Incyte Corp (OQ:INCY)
Business Focus: Biopharmaceuticals
Apr 23, 2024 07:00 am ET
Incyte Announces Acquisition of Escient Pharmaceuticals and its Pipeline of First-in-Class Oral MRGPR Antagonists
Incyte (Nasdaq:INCY) and Escient Pharmaceuticals, a clinical-stage drug discovery and development company advancing novel small molecule therapeutics for systemic immune and neuro-immune disorders, have entered into a definitive agreement under which Incyte has agreed to acquire Escient, including EP262, a first-in-class, potent, highly selective, once-daily small molecule antagonist of Mas-related G protein-coupled receptor X2 (MRGPRX2) and EP547, a first-in-class oral MRGPRX4 antagonist.
Apr 11, 2024 08:00 am ET
Incyte to Report First Quarter Financial Results
Incyte (Nasdaq:INCY) announced today that it has scheduled its first quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, April 30, 2024.
Apr 01, 2024 08:30 am ET
Incyte and CMS Announce Collaboration and License Agreement for Povorcitinib, an Oral JAK1 Inhibitor, in Mainland China, Hong Kong, Macau, Taiwan and Southeast Asia
Incyte (Nasdaq:INCY) (“Incyte”) and China Medical System Holdings Limited (“CMS” or the “Group”) are pleased to announce that on March 31, 2024, Incyte and CMS, through a wholly-owned dermatology medical aesthetic subsidiary of the Company (“CMS Skinhealth”), entered into a Collaboration and License Agreement for the development and commercialization of povorcitinib (the “Product”), a selective oral JAK1 inhibitor, to research, develop, register and commercialize the Product in Mainland China, Hong Kong, Macao, Taiwan Region and eleven Southeast Asian countries (the “Territory”) and a non-excl
Mar 29, 2024 04:30 pm ET
Incyte Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
Incyte (Nasdaq:INCY) announced today that it granted equity inducement awards to Matteo Trotta, the Company’s new Executive Vice President and General Manager of U.S. Dermatology, pursuant to the Company’s 2024 Inducement Stock Incentive Plan. The awards were approved by the compensation committee of the Company’s Board of Directors as an inducement material to the new employee entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).
Mar 10, 2024 04:05 pm ET
Incyte Announces New Data from Phase 2 Study Evaluating Ruxolitinib Cream (Opzelura®) in Patients with Mild-to-Moderate Hidradenitis Suppurativa
Incyte (Nasdaq:INCY) today announced new results from a Phase 2 study evaluating the efficacy and safety of twice-daily ruxolitinib cream 1.5% (Opzelura®) in adult patients with Hurley stage 1 or 2 (mild-to-moderate) hidradenitis suppurativa (HS). These data were presented as a late-breaking oral presentation (Session: S050 – Late-Breaking Research: Session 2) at the American Academy of Dermatology (AAD) Annual Meeting, held from March 8-12, 2024, in San Diego.
Mar 10, 2024 04:05 pm ET
Incyte Presents New Late-Breaking Data from Phase 2 Study Evaluating Povorcitinib in Patients with Prurigo Nodularis
Incyte (Nasdaq:INCY) today announced results from a Phase 2 study evaluating the efficacy and safety of povorcitinib (INCB54707), an oral JAK1 inhibitor, in adult patients with prurigo nodularis (PN). These data were presented as a late-breaking oral presentation (Session: S050 – Late-Breaking Research: Session 2) at the American Academy of Dermatology (AAD) Annual Meeting, held from March 8-12, 2024, in San Diego.
Mar 04, 2024 08:00 am ET
New Data from Incyte’s Growing Dermatology Portfolio to be Presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting
Incyte (Nasdaq:INCY) today announced multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming 2024 American Academy of Dermatology (AAD) Annual Meeting, held March 8-12, 2024, in San Diego.
Feb 29, 2024 10:19 am ET
Incyte Launches The Unseen Journey to Elevate the Hidden Impact of Myeloproliferative Neoplasms (MPNs) on Patients’ Lives through Generative AI
Incyte (Nasdaq: INCY) today announced the launch of The Unseen Journey, a program that brings to life the hidden emotional and physical toll of myeloproliferative neoplasms (MPNs), a group of rare, chronic and progressive blood cancers. Through the use of generative artificial intelligence (AI), the stories and experiences of MPN patients were transformed into unique images to help them show their health care team and their loved ones the significant impact of their MPN symptoms.
Feb 29, 2024 07:30 am ET
Knight Therapeutics Announces Launch of Minjuvi® in Brazil
Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of Minjuvi® (tafasitamab) by its Brazilian affiliate, United Medical Ltda. Minjuvi® is indicated in combination...
Feb 27, 2024 04:08 pm ET
Incyte Announces U.S. Food and Drug Administration Grants Priority Review for Axatilimab for the Treatment of Chronic Graft-Versus-Host Disease
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for axatilimab, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. The Prescription Drug User Fee Act (PDUFA) date for the FDA decision is August 28, 2024.
Feb 15, 2024 08:00 am ET
Incyte to Present at Upcoming Investor Conference
Incyte (Nasdaq:INCY) announced today that it will present at the Cowen 44th Annual Health Care Conference on Monday, March 4, 2024 at 9:50 a.m. (EST) in Boston.
Feb 13, 2024 07:00 am ET
Incyte Reports 2023 Fourth Quarter and Year-End Financial Results, Provides 2024 Financial Guidance and Highlights R&D Priorities
Incyte (Nasdaq:INCY) today reports 2023 fourth quarter financial results, provides 2024 financial guidance and provides a status update on the Company’s research and development portfolio.
Feb 05, 2024 04:46 pm ET
Incyte Gains Exclusive Global Development and Commercialization Rights to Tafasitamab (Monjuvi®)
“This new agreement with MorphoSys provides Incyte with exclusive global rights to tafasitamab and full control over its development and commercialization, allowing us to realize significant operating efficiencies and cost synergies,” said Hervé Hoppenot, Chief Executive Officer, Incyte.
Jan 23, 2024 08:00 am ET
Incyte to Report Fourth Quarter and Year-End 2023 Financial Results
Incyte (Nasdaq:INCY) announced today that it has scheduled its fourth quarter and year-end 2023 financial results conference call and webcast for 8:00 a.m. ET on Tuesday, February 13, 2024.
Jan 08, 2024 08:30 am ET
Incyte Highlights Growth Opportunities and Provides Business Updates at the 42nd Annual J.P. Morgan Healthcare Conference
Incyte (Nasdaq:INCY) will highlight growth opportunities and provide key updates across its investigational pipeline and commercial portfolio during a presentation today at 7:30 a.m. PT at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco.
Dec 12, 2023 08:00 am ET
Incyte to Present at Upcoming Investor Conferences
Incyte (Nasdaq:INCY) announced today that it will present at the following investor conferences during the month of January:
Dec 10, 2023 05:00 pm ET
Incyte and Syndax Present Additional Data from Positive AGAVE-201 Trial at ASH Plenary Session Showing Axatilimab Efficacy Including Durable Responses in Chronic Graft-Versus-Host Disease
Incyte (Nasdaq:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX) today announced the full results from the pivotal Phase 2 AGAVE-201 trial of axatilimab, an anti-CSF-1R antibody, in adult and pediatric patients with refractory chronic graft-versus-host disease (GVHD) who had received at least two prior lines of systemic therapy. These data are featured today in the Plenary Scientific Session (Abstract #1) at the 65th American Society of Hematology Annual Meeting 2023 (ASH 2023), held December 9-12, 2023, in San Diego and virtually.
Nov 02, 2023 09:00 am ET
Incyte to Spotlight More Than 40 Hematology and Oncology Abstracts Including a Plenary Presentation at the ASH Annual Meeting
Incyte (Nasdaq:INCY) today announced that more than 40 abstracts highlighting data from eight of its hematology and oncology products will be presented at the upcoming 65th American Society of Hematology Annual Meeting 2023 (ASH 2023), held December 9-12, 2023, in San Diego and virtually.
Oct 31, 2023 07:00 am ET
Incyte Reports 2023 Third Quarter Financial Results and Provides Updates on Key Clinical Programs
Incyte (Nasdaq:INCY) today reports 2023 third quarter financial results, and provides a status update on the Company’s clinical development portfolio.
Oct 27, 2023 08:00 am ET
Science Magazine Recognizes Incyte as #2 “Top Employer” of 2023
Science magazine announced today that for the sixth consecutive year, Incyte has been named a top five employer based on its annual survey of approximately 6,800 individuals. Incyte ranked second on this year’s list, two spots higher than its 2022 ranking, and was specifically recognized for its loyal employees, social responsibility and treating employees with respect.
Oct 18, 2023 08:00 am ET
Incyte to Present at Upcoming Investor Conferences
Incyte (Nasdaq:INCY) announced today that it will present at the following investor conferences during the month of November:
Oct 16, 2023 08:00 am ET
Incyte Announces New Data from across its Oncology Portfolio to be Presented at ESMO Congress 2023
Incyte (Nasdaq:INCY) today announced that abstracts featuring new data from its oncology portfolio will be presented at the upcoming European Society for Medical Oncology (ESMO) Congress 2023, held October 20-24 in Madrid.
Oct 13, 2023 10:30 am ET
Incyte Announces New Data for Ruxolitinib Cream (Opzelura®) in Children with Atopic Dermatitis
Incyte (Nasdaq:INCY) today announced expanded results from the pivotal Phase 3 TRuE-AD3 study evaluating the safety and efficacy of ruxolitinib cream (Opzelura®) in children (age ≥2 to
Oct 13, 2023 08:00 am ET
Data From Incyte’s Povorcitinib Clinical Program to Be Featured at the 8th Annual Symposium on Hidradenitis Suppurativa Advances (SHSA)
Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring new data from the company’s clinical program on povorcitinib, an investigational oral JAK-1 inhibitor, have been accepted for oral presentation at the 8th Annual Symposium on Hidradenitis Suppurativa Advances (SHSA) held October 13-15 in Phoenix.
Oct 12, 2023 09:00 am ET
Global CAR T-cell Therapy Market Projected to Reach $83 Billion by 2032
FinancialNewsMedia.com News Commentary - Significant influences driving the CAR T-cell therapy market is a rising demand for model therapeutics for treatment of cancer, increase in prevalence of cancer and an escalating awareness of CAR T-cell...
Oct 11, 2023 10:30 am ET
New Long-Term Data from Incyte Phase 3 TRuE-V Program Demonstrates Efficacy of Continued Treatment with Opzelura® (Ruxolitinib) Cream in Nonsegmental Vitiligo Patients
Incyte (Nasdaq:INCY) today announced new results of a pooled analysis of long-term extension (LTE) data from the pivotal Phase 3 TRuE-V program assessing Opzelura® (ruxolitinib) cream 1.5% in patients 12 years of age and older with nonsegmental vitiligo who previously experienced limited or no response to treatment at Week 24. These data were presented today in a late-breaking oral presentation (Abstract #6479; Session: D1T01.1I: Late Breaking News) at the European Academy of Dermatology and Venereology (EADV) Congress 2023, held from October 11-14 in Berlin.
Oct 11, 2023 09:15 am ET
Incyte and Mandy Moore Partner to Empower People with Atopic Dermatitis to Find Their Moments of Clarity
Incyte (Nasdaq:INCY) announced today its partnership with actress, singer and songwriter Mandy Moore on Moments of Clarity, an educational initiative highlighting the authentic stories of people living with mild to mode
Oct 11, 2023 08:15 am ET
Incyte Announces Positive 52-Week Data from Phase 2b Study Evaluating Povorcitinib (INCB54707) in Patients with Extensive Nonsegmental Vitiligo
Incyte (Nasdaq:INCY) today announced new 52-week data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo. Results showed that treatment with oral povorcitinib was associated with substantial total body and facial repigmentation across all treatment groups at Week 52. These data were presented today in a late-breaking oral presentation (Abstract #6749 Session: D1T01.1A – Late-Breaking News) at the European Academy of Dermatology and Venereology (EADV) Congre
Oct 10, 2023 04:45 pm ET
Knight Therapeutics Announces Regulatory Submission of Pemigatinib in Brazil
Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Brazilian affiliate, United Medical Ltd., has submitted a marketing authorization application for pemigatinib to...
Oct 10, 2023 08:00 am ET
Incyte to Report Third Quarter Financial Results
Incyte (Nasdaq:INCY) announced today that it has scheduled its third quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, October 31, 2023.
Sep 29, 2023 01:43 pm ET
Incyte to Present Multiple Studies from Dermatology Portfolio at 2023 European Academy of Dermatology and Venereology (EADV) Congress
Incyte (Nasdaq:INCY) today announced multiple abstracts featuring new data from across its dermatology portfolio have been accepted for presentation at the upcoming European Academy of Dermatology and Venereology (EADV) Congress 2023 held October 11-14 in Berlin.
Aug 22, 2023 08:00 am ET
Incyte to Present at Upcoming Investor Conferences
Incyte (Nasdaq:INCY) announced today that it will present at the following investor conferences during the month of September:
Aug 01, 2023 07:00 am ET
Incyte Reports 2023 Second Quarter Financial Results and Provides Updates on Key Clinical Programs
Incyte (Nasdaq:INCY) today reports 2023 second quarter financial results, and provides a status update on the Company’s clinical development portfolio.
Jul 31, 2023 04:01 pm ET
Replimune and Incyte Enter into Clinical Trial Collaboration and Supply Agreement to Evaluate RP1 and INCB99280 in Patients with Cutaneous Squamous Cell Carcinoma
Replimune Group, Inc. (NASDAQ:REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, and Incyte (NASDAQ:INCY), a global biopharmaceutical company, today announced a clinical trial collaboration and supply agreement to study RP1, Replimune’s lead product candidate, in combination with INCB99280, Incyte’s small molecule oral PD-L1 inhibitor.
Jul 24, 2023 07:00 am ET
Syndax and Incyte Announce Positive Topline Results from the Pivotal AGAVE-201 Trial of Axatilimab in Chronic Graft-Versus-Host Disease
– Trial met its primary endpoint across all cohorts with an overall response rate (ORR) of 74% at a dose of 0.3 mg/kg administered every two weeks –
Jul 11, 2023 04:05 pm ET
Incyte Announces Positive Topline Results from Phase 3 Trial Evaluating Ruxolitinib Cream (Opzelura®) in Children with Atopic Dermatitis
Incyte (Nasdaq:INCY) today announced positive topline results from its randomized, vehicle-controlled, pivotal Phase 3 TRuE-AD3 study evaluating the safety and efficacy of ruxolitinib cream (Opzelura®) in children (age ≥2 to
Jul 11, 2023 08:00 am ET
Incyte to Report Second Quarter Financial Results
Incyte (Nasdaq:INCY) announced today that it has scheduled its second quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, August 1, 2023.
Jul 05, 2023 06:12 am ET
MHRA Grants Marketing Authorisation for Opzelura® (ruxolitinib) Cream for the Treatment of Non-Segmental Vitiligo with Facial Involvement in Adults and Adolescents
Incyte Biosciences UK today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for Opzelura® (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Opzelura is the first and only approved treatment in the United Kingdom (UK) to offer eligible patients with non-segmental vitiligo support for repigmentation. The MHRA decision follows the European Commission approval1 earlier in April.
May 25, 2023 05:01 pm ET
Data from Across Incyte’s Oncology Portfolio Accepted for Presentation at the 2023 ASCO Annual Meeting and EHA2023 Hybrid Congress
Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from across its oncology portfolio will be presented at the upcoming 2023 American Society of Clinical Oncology (ASCO) Annual Meeting held June 2-6 in Chicago, and at the European Hematology Association 2023 (EHA2023) Hybrid Congress held in Frankfurt, Germany, from June 8-11 and virtually from June 14-15.
May 23, 2023 08:00 am ET
Incyte to Present at Upcoming Investor Conferences
Incyte (Nasdaq:INCY) announced today that it will present at the following investor conferences during the month of June:
May 08, 2023 08:30 am ET
Incyte Strengthens Research & Development Efforts Appointing Pablo J. Cagnoni, M.D. to New Leadership Role
Incyte (Nasdaq:INCY) today announced the creation of a new leadership role, appointing Pablo J. Cagnoni, M.D. President and Head of Research & Development (R&D) effective June 5, 2023. In this role and as a member of the Executive Team, Dr. Cagnoni will lead Incyte’s R&D efforts across its portfolio of programs in Oncology, Hematology and Inflammation and Autoimmunity including Dermatology.
May 02, 2023 07:00 am ET
Incyte Reports 2023 First Quarter Financial Results and Provides Updates on Key Clinical Programs
Incyte (Nasdaq:INCY) today reports 2023 first quarter financial results, and provides a status update on the Company’s clinical development portfolio.
May 01, 2023 03:00 pm ET
Incyte Announces Results from SCRATCH-AD Trial Demonstrating Substantial and Rapid Itch Reduction in Patients with Mild-Moderate Atopic Dermatitis Treated with Opzelura® (ruxolitinib) Cream
Incyte (Nasdaq:INCY) today announced new data from the Phase 2 SCRATCH-AD trial evaluating the short-term clinical benefits of Opzelura® (ruxolitinib) cream 1.5% to control pruritus (itching) and reduce disease severity in adult patients with atopic dermatitis (AD), the most common type of eczema. These data were featured in a poster presentation (Poster #396) at the Revolutionizing Atopic Dermatitis (RAD) Conference, held from April 29-May 1 in Washington, D.C.
Apr 24, 2023 02:19 pm ET
SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Incyte Corporation – INCY
Pomerantz LLP is investigating claims on behalf of investors of Incyte Corporation (“Incyte” or the “Company”) (NASDAQ: INCY). Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext. 7980. The...
Apr 20, 2023 10:21 am ET
Incyte Announces European Commission Approval of Opzelura® (ruxolitinib) Cream for the Treatment of Non-Segmental Vitiligo with Facial Involvement in Adults and Adolescents
Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has granted a marketing authorization for Opzelura® (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age. Opzelura is the first and only approved treatment in the European Union (EU) to offer support for repigmentation in eligible patients with non-segmental vitiligo, a chronic autoimmune disease characterized by depigmentation of skin and reduced quality of life.
Apr 19, 2023 05:48 am ET
SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Incyte Corporation - INCY
NEW YORK, April 19, 2023 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Incyte Corporation ("Incyte" or the "Company") (NASDAQ: INCY). Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext. 7980.
Apr 18, 2023 08:00 am ET
Incyte to Present at Upcoming Investor Conferences
Incyte (Nasdaq:INCY) announced today that it will present at the following investor conferences during the month of May:
Apr 16, 2023 03:15 pm ET
SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Incyte Corporation - INCY
Pomerantz LLP is investigating claims on behalf of investors of Incyte Corporation (“Incyte” or the “Company”) (NASDAQ: INCY). Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext. 7980. The...
Apr 16, 2023 03:01 pm ET
MorphoSys and Incyte Announce Five-Year Results of L-MIND Study Showed Prolonged, Durable Responses in Relapsed or Refractory DLBCL Patients Treated with Monjuvi® (tafasitamab-cxix)
MorphoSys U.S. Inc., a fully owned subsidiary of MorphoSys AG (FSE: MOR; NASDAQ: MOR), and Incyte (Nasdaq: INCY) today announced final five-year follow-up data from the Phase 2 L-MIND study showing that Monjuvi® (tafasitamab-cxix) plus lenalidomide followed by Monjuvi monotherapy provided prolonged, durable responses in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). These data were featured as a late-breaking oral presentation (Abstract # CT022) at the American Association for Cancer Research (AACR) Annual Meeting 2023 in Orlando, Florida.
Apr 11, 2023 08:00 am ET
Incyte to Report First Quarter Financial Results
Incyte (Nasdaq:INCY) announced today that it has scheduled its first quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, May 2, 2023.
Apr 09, 2023 02:38 am ET
SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Incyte Corporation - INCY
Pomerantz LLP is investigating claims on behalf of investors of Incyte Corporation (“Incyte” or the “Company”) (NASDAQ: INCY). Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext. 7980. The...
Mar 27, 2023 02:00 am ET
Incyte Announces Japanese Approval of Pemazyre® (pemigatinib) for the Treatment of Patients with Myeloid/Lymphoid Neoplasms (MLNs)
Incyte (Nasdaq:INCY) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of myeloid/lymphoid neoplasms (MLNs) with FGFR1 fusion (also known as 8p11 myeloproliferative syndrome). MLNs are a rare, aggressive group of cancers characterized by an over-production of myeloid cells, or bone tissue, with the tendency to rapidly progress to an acute myeloid leukemia (AML).
Mar 23, 2023 08:55 pm ET
Incyte Provides Regulatory Update on Ruxolitinib Extended-Release Tablets
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for ruxolitinib extended-release (XR) tablets, a JAK1/JAK2 inhibitor, for once-daily (QD) use in the treatment of certain types of myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD).
Mar 22, 2023 01:14 pm ET
Incyte Announces FDA Approval of Zynyz™ (retifanlimab-dlwr) for the Treatment of Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC)
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynyz™ (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). The Biologics License Application (BLA) for Zynyz for this indication has been approved under accelerated approval by the U.S. FDA based on tumor response rate and duration of response (DOR). Continued approval of Zynyz for this indication may be contingent on verification and des
Mar 18, 2023 03:40 pm ET
Incyte Announces Data from Phase 2b Study Evaluating Povorcitinib (INCB54707) in Patients with Extensive Nonsegmental Vitiligo
Incyte (Nasdaq:INCY) today announced new data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo. These data were presented today in a late-breaking oral presentation (Session: S042 – Late-Breaking Research: Session 2) at the 2023 American Academy of Dermatology (AAD) Annual Meeting, held from March 17-21 in New Orleans.
Mar 18, 2023 10:40 am ET
Incyte Announces Long-Term Extension Data from Phase 3 TRuE-V Program Demonstrating Long-Term Safety and Durability of Response of Opzelura® (Ruxolitinib) Cream in Vitiligo
Incyte (Nasdaq:INCY) today announced new 104-week results from the pivotal Phase 3 TRuE-V clinical trial program evaluating Opzelura® (ruxolitinib) cream 1.5% in patients 12 years of age and older with nonsegmental vitiligo, a chronic autoimmune disease characterized by depigmentation of skin. These data were presented today in two late-breaking oral presentations (Session: S025 – Late Breaking Research: Session 1) at the 2023 American Academy of Dermatology (AAD) Annual Meeting, held from March 17-21 in New Orleans.
Mar 14, 2023 06:30 pm ET
Incyte Announces Data from Across its Oncology Portfolio will be Presented at the AACR Annual Meeting 2023
Incyte (Nasdaq:INCY) today announced that multiple abstracts from across its oncology portfolio will be presented during the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023, held April 14-19, in Orlando, Florida.
Mar 06, 2023 12:23 pm ET
Multiple Abstracts from Incyte’s Growing Dermatology Portfolio Featured at American Academy of Dermatology (AAD) Annual Meeting
Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming 2023 American Academy of Dermatology (AAD) Annual Meeting, held March 17-21, 2023, in New Orleans.
Mar 03, 2023 04:35 pm ET
Incyte Provides Update on Interim Analysis of Phase 3 LIMBER-304 Study of Parsaclisib and Ruxolitinib in Patients with Myelofibrosis
While further review of the data is conducted, Incyte will inform investigators of the results and work with them to appropriately conclude the study in a manner consistent with the best interest of each patient. Data from this study will be submitted for presentation at an upcoming scientific meeting.
Feb 24, 2023 07:07 am ET
Incyte Announces Positive CHMP Opinion for Ruxolitinib Cream (Opzelura™) for the Treatment of Non-segmental Vitiligo in Adults and Adolescents
Incyte (Nasdaq:INCY) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of ruxolitinib cream (Opzelura™) for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
Feb 16, 2023 08:00 am ET
Incyte to Present at Upcoming Investor Conference
Incyte (Nasdaq:INCY) announced today that it will present at the Cowen 43rd Annual Health Care Conference on Monday, March 6, 2023 at 11:10 a.m. (EST) in Boston.
Feb 10, 2023 08:20 am ET
Incyte Announces 52-Week Results from Phase 2 Study Evaluating Povorcitinib (INCB54707) in Patients with Hidradenitis Suppurativa
Incyte (Nasdaq:INCY) today announced new 52-week results from a Phase 2 study evaluating the efficacy and safety of povorcitinib (formerly INCB54707), an oral JAK1 inhibitor, in adult patients with hidradenitis suppurativa (HS). These data were presented as an oral presentation (Abstract #258) at the 12th Conference of the European Hidradenitis Suppurativa Foundation, held from February 8-10, 2023, in Florence, Italy.
Feb 07, 2023 07:00 am ET
Incyte Reports 2022 Fourth Quarter and Year-end Financial Results, Provides 2023 Financial Guidance and Updates on Key Clinical Programs
Incyte (Nasdaq:INCY) today reports 2022 fourth quarter financial results, provides 2023 financial guidance and provides a status update on the Company’s clinical development portfolio.
Jan 24, 2023 08:00 am ET
Incyte to Present at Upcoming Investor Conference
Incyte (Nasdaq:INCY) announced today that it will present at the Guggenheim Healthcare Talks l Oncology Day on Wednesday, February 8, 2023 at 1:35 p.m. (EST) in New York.
Jan 17, 2023 08:00 am ET
Incyte to Report Fourth Quarter and Year-End 2022 Financial Results
Incyte (Nasdaq:INCY) announced today that it has scheduled its fourth quarter and year-end 2022 financial results conference call and webcast for 8:00 a.m. ET on Tuesday, February 7, 2023.
Dec 15, 2022 08:00 am ET
Incyte to Present at Upcoming Investor Conferences
Incyte (Nasdaq:INCY) announced today that it will present at the following investor conferences during the month of January:
Dec 11, 2022 03:00 pm ET
Incyte’s Novel Mutant CALR Antibody Unveiled at ASH 2022 Plenary Scientific Session
Incyte (Nasdaq:INCY) today announced new research detailing the development and mechanism of action of INCA033989, an Incyte-discovered, investigational novel anti-mutant calreticulin (CALR)-targeted monoclonal antibody. Pre-clinical data indicate that INCA033989 can alter disease course by reducing mutant CALR allele burden and thus may be an efficacious and safe treatment in patients with myelofibrosis (MF) and essential thrombocythemia (ET). This
Dec 10, 2022 03:00 pm ET
Incyte Announces Data from Two LIMBER Studies Evaluating Combination Treatments in Patients with Myelofibrosis (MF) Presented at ASH 2022
Incyte (Nasdaq:INCY) today announced new data from two of its LIMBER (Leadership In MPNs and GVHD BEyond Ruxolitinib) trials evaluating monotherapy and combination strategies using ruxolitinib (Jakafi®) with parsaclisib, its investigational phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor, and INCB00928 (zilurgisertib), its activin receptor-like kinase (ALK2) inhibitor, in patients with myelofibrosis (MF). These Phase 2 and Phase 1/2 trials (
Dec 05, 2022 06:00 am ET
Syndax Pharmaceuticals and Incyte Announce Axatilimab Phase 1/2 Data in Patients with Chronic Graft-Versus-Host Disease Published in the Journal of Clinical Oncology
– Treatment with axatilimab resulted in an overall response rate (ORR) of 67% across all patients; and an ORR of 82% in patients dosed at 1 mg/kg every 2 weeks in the Phase 2 portion of the trial –
Dec 02, 2022 08:30 am ET
Incyte and CMS Announce Collaboration and License Agreement for Ruxolitinib Cream in Greater China and Southeast Asia
Incyte (NASDAQ:INCY) and CMS Aesthetics, a dermatology medical aesthetic company and subsidiary of CMS (HKEX: 00867), today announced that the companies have entered into a Collaboration and License Agreement for the development and commercialization of ruxolitinib cream, a novel cream formulation of Incyte’s selective JAK inhibitor ruxolitinib, for the treatment of autoimmune and inflammatory dermatologic diseases in Greater China and certain countries in Southeast Asia.
Nov 17, 2022 08:00 am ET
Incyte to Present at Upcoming Investor Conferences
Incyte (Nasdaq:INCY) announced today that it will present at the following investor conferences during the month of November and December:
Nov 07, 2022 08:15 am ET
Incyte And Mirati Therapeutics Enter Into Clinical Trial Collaboration and Supply Agreement to Evaluate INCB99280 and Adagrasib in Patients with KRASG12C-Mutated Solid Tumors
Incyte (NASDAQ:INCY) and Mirati Therapeutics, Inc. (NASDAQ:MRTX), a clinical-stage targeted oncology company, today announced a clinical trial collaboration and supply agreement to investigate the combination of INCB99280, Incyte’s small molecule PD-L1 inhibitor, and adagrasib, a KRASG12C selective inhibitor.
Nov 07, 2022 08:00 am ET
Data From Incyte’s Oncology Portfolio to Be Presented at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting
Incyte (Nasdaq:INCY) today announced that abstracts featuring data from its oncology portfolio will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, held November 8-12, 2022, in Boston and virtually.
Nov 03, 2022 10:24 am ET
More than 50 Abstracts from Incyte’s Robust Oncology Portfolio to be Featured at the 64th ASH Annual Meeting
Incyte (Nasdaq:INCY) will present data from its oncology portfolio at the upcoming 64th American Society of Hematology Annual Meeting (ASH 2022), held December 10-13, 2022, in New Orleans and virtually. More than 50 abstracts featuring Incyte compounds will be presented, highlighting its robust portfolio and clinical development programs.
Nov 01, 2022 07:00 am ET
Incyte Reports 2022 Third Quarter Financial Results and Provides Updates on Key Clinical Programs
Incyte (Nasdaq:INCY) today reports 2022 third quarter financial results, and provides a status update on the Company’s clinical development portfolio.
Oct 19, 2022 06:17 pm ET
Pivotal Phase 3 Data Showing Significant Improvements in Facial and Total Body Repigmentation with Ruxolitinib Cream (Opzelura™) in Vitiligo Published in New England Journal of Medicine
Incyte (Nasdaq:INCY) today announced that data from the pivotal Phase 3 TRuE-V clinical trial program evaluating ruxolitinib cream (Opzelura™) 1.5% in patients 12 years of age and older with nonsegmental vitiligo have been published in The New England Journal of Medicine (NEJM). In the trials (TRuE-V1 and TRuE-V2), application of ruxolitinib cream resulted in significant facial and total body repigmentation versus vehicle-control as shown by greater proportions of patients reaching the facial and total body Vitiligo Area Scoring Index (F-VASI and T-VASI, respectively) endpoints at Week
Oct 11, 2022 08:00 am ET
Incyte to Report Third Quarter Financial Results
Incyte (Nasdaq:INCY) announced today that it has scheduled its third quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, November 1, 2022.
Oct 06, 2022 06:12 pm ET
Knight Therapeutics Announces Regulatory Submission for Tafasitamab in Brazil
Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Brazilian affiliate, United Medical Ltd., has submitted a marketing authorization application for tafasitamab in...
Oct 04, 2022 08:00 am ET
Incyte Names New Member to Its Board of Directors
Incyte (Nasdaq:INCY) announces the appointment of Susanne Schaffert, Ph.D., as a new member of its Board of Directors.
Oct 03, 2022 06:00 am ET
Incyte Announces Agreement to Acquire Medicxi-backed Villaris Therapeutics and Auremolimab (VM6), an Anti-IL-15Rβ Monoclonal Antibody
Incyte (NASDAQ:INCY) today announced that the Company has entered into an agreement to acquire Villaris Therapeutics, an asset-centric biopharmaceutical company seeded by Medicxi and focused on the development of novel antibody therapeutics for vitiligo. Its lead asset, auremolimab (VM6), an anti-IL-15Rβ monoclonal antibody (mAb), is expected to enter clinical development in 2023.
Aug 26, 2022 10:00 am ET
Incyte Announces FDA Approval of Pemazyre® (pemigatinib) as the First and Only Targeted Treatment for Myeloid/Lymphoid Neoplasms (MLNs) with FGFR1 Rearrangement
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. MLNs with FGFR1 rearrangement are extremely rare and aggressive blood cancers that may impact less than 1 in 100,000 people in the United States1.
Aug 24, 2022 08:00 am ET
Data from Incyte’s Dermatology Portfolio Accepted for Presentation at the 2022 European Academy of Dermatology and Venereology (EADV) Congress
Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming 2022 European Academy of Dermatology and Venereology (EADV) Congress, held September 7-10, 2022, in Milan and virtually.
Aug 23, 2022 08:00 am ET
Incyte to Present at Upcoming Investor Conference
Incyte (Nasdaq:INCY) announced today that it will present at the Morgan Stanley 20th Annual Global Healthcare Conference on Monday, September 12, 2022 at 12:30 p.m. (EDT) in New York.
Aug 02, 2022 07:00 am ET
Incyte Reports 2022 Second Quarter Financial Results and Provides Updates on Key Clinical Programs
Incyte (Nasdaq:INCY) today reports 2022 second quarter financial results, and provides a status update on the Company’s clinical development portfolio.
Jul 18, 2022 09:08 pm ET
Incyte Announces U.S. FDA Approval of Opzelura™ (ruxolitinib) Cream for the Treatment of Vitiligo
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Opzelura is the first and only FDA-approved treatment for repigmentation in patients with vitiligo, and the only topical formulation of a Janus kinase (JAK) inhibitor approved in the United States. Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin.
Jul 12, 2022 08:00 am ET
Incyte to Report Second Quarter Financial Results
Incyte (Nasdaq:INCY) announced today that it has scheduled its second quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, August 2, 2022.
Jun 13, 2022 09:50 pm ET
FDA Approves Lilly and Incyte's OLUMIANT® (baricitinib) As First and Only Systemic Medicine for Adults with Severe Alopecia Areata
INDIANAPOLIS, June 13, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata (AA), available as 4-mg, 2-mg and 1-mg tablets.1 The recommended dose is OLUMIANT 2-mg/day, with an increase to 4-mg/day if treatment response is inadequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treat
May 26, 2022 06:00 am ET
Data from Incyte’s Robust and Progressing Oncology Portfolio to be Presented at 2022 EHA Annual Meeting
Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its oncology portfolio will be presented at the upcoming European Hematology Association 2022 (EHA2022) Congress (June 9-17; virtual and in Vienna).
May 24, 2022 08:00 am ET
Incyte to Present at Upcoming Investor Conference
The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.
May 20, 2022 08:11 am ET
CHMP Recommends Approval of Lilly and Incyte's OLUMIANT® (baricitinib) as the First and Only Centrally-Authorized Treatment for Adults with Severe Alopecia Areata (AA)
INDIANAPOLIS, May 20, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for OLUMIANT® (baricitinib) for the treatment of adults with severe alopecia areata (AA).
May 11, 2022 06:45 am ET
FDA Approves Lilly and Incyte's OLUMIANT® (baricitinib) for the Treatment of Certain Hospitalized Patients with COVID-19
OLUMIANT is the first and only JAK inhibitor FDA-approved for the treatment of COVID-19 in certain hospitalized adults requiring various degrees of oxygen support
May 05, 2022 01:20 am ET
Incyte Announces European Commission Approval of Jakavi® (ruxolitinib) as the First Post-Steroid Treatment for Acute and Chronic Graft-Versus-Host Disease
Incyte (Nasdaq:INCY) today announced the European Commission (EC) has approved Jakavi® (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic GVHD who have inadequate response to corticosteroids or other systemic therapies. Ruxolitinib is marketed as Jakavi by Novartis in Europe and as Jakafi® by Incyte in the United States.
May 04, 2022 04:15 pm ET
Incyte to Present at Upcoming Investor Conference
Incyte (Nasdaq:INCY) announced today that it will present at the 2022 RBC Capital Markets Healthcare Conference on Tuesday, May 17, 2022 at 10:30 a.m. ET in New York.
May 03, 2022 07:00 am ET
Incyte Reports 2022 First Quarter Financial Results and Provides Updates on Key Clinical Programs
Incyte (Nasdaq:INCY) today reports 2022 first quarter financial results, and provides a status update on the Company’s clinical development portfolio.
Apr 28, 2022 04:05 pm ET
Incyte and Maruho Announce Strategic Alliance Agreement for Ruxolitinib Cream in Japan
Incyte (NASDAQ:INCY) and Maruho Co., Ltd. today announced that the companies have entered into a Strategic Alliance Agreement for the development, manufacturing and exclusive commercialization of ruxolitinib cream, a novel cream formulation of Incyte’s selective JAK2 inhibitor ruxolitinib, for treatment of autoimmune and inflammatory dermatology indications in Japan.
Apr 22, 2022 09:40 am ET
Incyte Announces Positive CHMP Opinion for Capmatinib (Tabrecta®) for the Treatment of METex14 Advanced Non-Small Cell Lung Cancer
Incyte (Nasdaq:INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency’s (EMA) has issued a positive opinion that recommends granting marketing authorization for capmatinib (Tabrecta®) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymalepithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
Apr 12, 2022 08:00 am ET
Incyte to Report First Quarter Financial Results
Incyte (Nasdaq:INCY) announced today that it has scheduled its first quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, May 3, 2022.
Mar 26, 2022 11:20 am ET
Nearly 40% of Adults with Alopecia Areata Taking OLUMIANT® 4-mg Saw at Least 80% Scalp Hair Coverage at 52 Weeks in Lilly's Pivotal Phase 3 Studies
New England Journal of Medicine published OLUMIANT 36-week alopecia areata data today
Mar 26, 2022 10:40 am ET
Incyte Announces 52-Week Data From the Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream (Opzelura™) in Patients With Vitiligo
Incyte (Nasdaq:INCY) today announced new 52-week results from its pivotal Phase 3 TRuE-V clinical trial program evaluating ruxolitinib cream (Opzelura™), a topical JAK1/JAK2 inhibitor, in adolescent and adult patients (age ≥12 years) with nonsegmental vitiligo. These data were presented today as an oral presentation in a late-breaking abstract session (Session #S026 – Late-Breaking Research: Clinical Trials) at the 2022 American Academy of Dermatology (AAD) Annual Meeting, held from March 25-29 in Boston.
Mar 25, 2022 08:30 am ET
Incyte Announces Positive CHMP Opinion for Ruxolitinib (Jakavi®) for the Treatment of Acute and Chronic Graft-Versus-Host Disease
Incyte (Nasdaq:INCY) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of ruxolitinib (Jakavi®) for the treatment of patients aged 12 years and older with acute graft-versus-host disease or chronic graft-versus-host disease (GVHD) and who have inadequate response to corticosteroids or other systemic therapies. If approved, ruxolitinib will be the first JAK1/2 inhibitor available for patients with GVHD in Europe.4 Ruxolitinib is marketed as Jakavi by Novartis in Eur
Mar 18, 2022 09:56 am ET
Incyte Announces Multiple Abstracts from its Dermatology Portfolio have been Accepted for Presentation at the 2022 American Academy of Dermatology (AAD) Annual Meeting
Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming American Academy of Dermatology (AAD) Annual Meeting, held March 25-29, 2022, in Boston.
Mar 14, 2022 08:00 am ET
Incyte Announces U.S. FDA Has Extended the Supplemental New Drug Application Review Period for Ruxolitinib Cream (Opzelura™) for the Treatment of Vitiligo
Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura™) for the treatment of vitiligo. The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to July 18, 2022.
Mar 01, 2022 07:55 am ET
Actuate Therapeutics Announces First Patient Enrolled in Phase 2 Clinical Trial of Elraglusib Plus Retifanlimab as Investigational First Line Therapy for Patients With Advanced Pancreatic Cancer
Actuate Therapeutics and The University of Kansas Cancer Center today announced the enrollment of the first patient on a Phase 2 study of elraglusib (9-ING-41) plus retifanlimab combined with gemcitabine/nab-paclitaxel for the treatment of patients...
Feb 15, 2022 08:00 am ET
Incyte to Present at Upcoming Investor Conference
Incyte (Nasdaq:INCY) announced today that it will present at the virtual Cowen 42nd Annual Health Care Conference on Monday, March 7, 2022 at 9:50 a.m. ET.
Feb 08, 2022 07:00 am ET
Incyte Reports 2021 Fourth Quarter and Year-End Financial Results, and Provides 2022 Financial Guidance and Updates on Key Clinical Programs
Incyte (Nasdaq:INCY) today reports 2021 fourth quarter financial results, provides 2022 financial guidance and a status update on the Company’s clinical development portfolio.
Feb 03, 2022 08:00 am ET
Incyte to Present at Upcoming Investor Conference
Incyte (Nasdaq:INCY) announced today that it will present at the 11th Annual SVB Leerink Global Healthcare Conference (Virtual) on Thursday, February 17, 2022 at 11:20 a.m. ET.
Jan 28, 2022 07:00 am ET
Updates on OLUMIANT® (baricitinib) Phase 3 lupus program and FDA review for atopic dermatitis
INDIANAPOLIS, Jan. 28, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) today announced updates on the Phase 3 development program for OLUMIANT® (baricitinib) in adults with active systemic lupus erythematosus (also referred to as SLE and lupus) and the status of the U.S. atopic dermatitis supplemental new drug application (sNDA).
Jan 25, 2022 04:30 pm ET
Incyte Provides Update on Parsaclisib and MCLA-145
Incyte (Nasdaq:INCY) today announced updates regarding the clinical development of parsaclisib, the Company’s next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), and MCLA-145, its CD137/PD-L1 bispecific antibody co-developed under a global collaboration and license agreement with Merus.
Jan 25, 2022 04:30 pm ET
Merus Appoints Shannon Campbell as Chief Commercial Officer and Regains Worldwide Rights to MCLA-145
Merus N.V. (Nasdaq: MRUS) (“Merus”, “the Company”, “we”, or “our”), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced the appointment of Shannon Campbell as...
Jan 18, 2022 08:00 am ET
Incyte to Report Fourth Quarter and Year-End 2021 Financial Results
Incyte (Nasdaq:INCY) announced today that it has scheduled its fourth quarter and year-end 2021 financial results conference call and webcast for 8:00 a.m. ET on Tuesday, February 8, 2022.
Dec 14, 2021 04:30 pm ET
Incyte Announces Acceptance and Priority Review of sNDA for Ruxolitinib Cream (Opzelura™) as a Treatment for Patients with Vitiligo
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for ruxolitinib cream 1.5% (Opzelura™) a topical JAK inhibitor, as a potential treatment for adolescents and adults (age ≥12 years) with vitiligo. The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. The Prescription Drug User Fee Act (PDUFA) target action date is April 18, 2022.
Dec 14, 2021 08:00 am ET
Incyte to Present at Upcoming Investor Conferences
Incyte (Nasdaq:INCY) announced today that it will present at the following investor conferences during the month of January:
Dec 11, 2021 12:00 pm ET
MorphoSys and Incyte Announce Additional Real-World Evidence Results from RE-MIND2 Study of Tafasitamab (Monjuvi®) in Combination with Lenalidomide for the Treatment of Relapsed or Refractory Diffuse
MorphoSys US Inc., a fully owned subsidiary of MorphoSys AG (FSE: MOR; NASDAQ: MOR), and Incyte (NASDAQ:INCY) today announced additional real-world evidence results from the RE-MIND2 study comparing tafasitamab (Monjuvi®) in combination with lenalidomide against the most frequently used treatments in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). These treatments include polatuzumab vedotin plus bendamustine and rituximab (Pola-BR), rituximab plus lenalidomide (R2), and CD19 chimeric antigen receptor T-cell (CAR-T) therapies. The data, which builds
Dec 11, 2021 09:00 am ET
Incyte Announces Updated Data Demonstrating Rapid and Durable Responses of Parsaclisib in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
Incyte (Nasdaq:INCY) today announced data from three ongoing Phase 2 studies evaluating parsaclisib, an investigational novel potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), for the treatment of patients with relapsed or refractory follicular lymphoma (FL) (CITADEL-203), marginal zone lymphoma (MZL) (CITADEL-204) and mantle cell lymphoma (MCL) (CITADEL-205). These data were accepted as oral presentations at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH 2021), held December 11–14, 2021 in Atlanta, Georgia and
Nov 09, 2021 08:00 am ET
Incyte to Present at Upcoming Investor Conference
Incyte (Nasdaq:INCY) announced today that it will present at the Evercore ISI 4th Annual HealthCONx Conference (Virtual) on Tuesday, November 30, 2021 at 2:15 p.m. ET.
Nov 09, 2021 07:30 am ET
OLUMIANT® Long-Term Safety Profile Established Up to 9.3 Years in Integrated Analysis of More Than 3,700 Patients with Rheumatoid Arthritis
INDIANAPOLIS, Nov. 9, 2021 /PRNewswire/ -- OLUMIANT® (baricitinib) maintained a consistent safety profile in a long-term, integrated safety analysis of patients with rheumatoid arthritis (RA) who received OLUMIANT for 14,744 patient years of exposure, in line with previously published findings. Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) will present these results, along with real-world safety results from 3,445 patients with RA in Japan, at ACR Convergence 2021, the American College of Rheumatology's virtual annual meeting taking place November 3-9, 2021. Detailed and additi
Nov 04, 2021 10:07 am ET
Cellenkos® Inc. Secures $15 Million Series A Financing to Accelerate the Development of Transformation Cell-Based Therapies
HOUSTON and SHANGHAI, Nov. 4, 2021 /PRNewswire/ -- Cellenkos® Inc. ("Cellenkos"), a biotech company focused on developing transformative novel T regulatory (Treg) cell therapies to treat autoimmune and inflammatory disorders, today announced the close of $15 million Series A financing led by BVCF Management Ltd ("BVCF"). Proceeds from this financing will be used to further its development on the Treg cell therapy platform to address high unmet needs in autoimmune and inflammatory disorders.
Nov 04, 2021 09:00 am ET
More than 35 Abstracts from Incyte’s Oncology Portfolio Accepted for Presentation at the 63rd Annual ASH Meeting and Exposition
Incyte (Nasdaq:INCY) today announced that numerous abstracts highlighting data from its oncology portfolio will be presented at the upcoming 63rd American Society of Hematology Annual Meeting and Exposition (ASH 2021), held December 11–14, 2021 in Atlanta, Georgia and virtually.
Nov 02, 2021 07:00 am ET
Incyte Reports 2021 Third Quarter Financial Results and Provides Updates on Key Clinical Programs
Incyte (Nasdaq:INCY) today reports 2021 third quarter financial results and provides a status update on the Company’s development portfolio.
Nov 01, 2021 09:16 am ET
Data from Incyte’s Oncology Portfolio Accepted for Presentation at the Society for Immunotherapy of Cancer (SITC) 2021 Annual Meeting
Incyte (Nasdaq:INCY) today announced that multiple abstracts highlighting data from its oncology portfolio will be presented at the Society for Immunotherapy of Cancer’s (SITC) 36th Annual Meeting, held from November 10-14, 2021 in Washington, D.C and virtually.
Nov 01, 2021 07:00 am ET
Incyte Announces Acceptance of NDA for Parsaclisib for Three Types of Relapsed or Refractory Non-Hodgkin Lymphomas
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for parsaclisib, an investigational novel potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), for the treatment of patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL).
Oct 28, 2021 07:47 am ET
Incyte Announces the Validation of the European Marketing Authorization Application for Ruxolitinib Cream in Vitiligo
Incyte (Nasdaq:INCY) today announced the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream, a topical JAK inhibitor, as a potential treatment for adolescents and adults (age >12 years) with non-segmental vitiligo with facial involvement. The validation of the MAA by the European Medicines Agency (EMA) confirms that the submission is ready to enter the formal review process.
Oct 13, 2021 08:00 am ET
Incyte to Report Third Quarter Financial Results
Incyte (Nasdaq:INCY) announced today that it has scheduled its third quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, November 2, 2021.
Oct 02, 2021 05:15 am ET
Incyte Announces Full Results From Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream (Opzelura™) in Patients With Vitiligo
Incyte (Nasdaq:INCY) today announced the full 24-week results from its pivotal Phase 3 TRuE-V clinical trial program investigating ruxolitinib cream (Opzelura™), a topical JAK inhibitor, in adolescent and adult patients (age ≥12 years) with nonsegmental vitiligo. These data will be presented today as a late-breaking oral presentation (Abstract #D3T01.2A) at the European Academy of Dermatology and Venereology (EADV) 30th Congress, held virtually from September 29-October 2, 2021.
Sep 30, 2021 05:56 am ET
OLUMIANT® Significantly Improved Hair Regrowth to At Least 80% Scalp Coverage as Early as 24 Weeks Across First Completed Phase 3 Studies for Alopecia Areata
INDIANAPOLIS, Sept. 30, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today detailed results from two pivotal Phase 3 trials (BRAVE-AA1 and BRAVE-AA2), which found once-daily OLUMIANT® (baricitinib) 4-mg was superior to placebo in achieving significant scalp hair regrowth as early as 24 weeks in adults with severe alopecia areata (AA) as defined by ≥50% scalp hair loss at baseline.
Sep 28, 2021 05:00 pm ET
Incyte Names New Member to Its Board of Directors
Incyte (Nasdaq:INCY) announces the appointment of Otis Brawley, M.D., as a new member of its Board of Directors, effective September 27, 2021.
Sep 27, 2021 06:00 am ET
Syndax Pharmaceuticals and Incyte Announce Global Collaboration to Develop and Commercialize Axatilimab for Chronic Graft-Versus-Host Disease and Other Fibrotic Diseases
WALTHAM, Mass. and WILMINGTON, Del., Sept. 27, 2021 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX) and Incyte (Nasdaq: INCY) announced today that they have entered into an exclusive worldwide collaboration and license agreement to develop and commercialize axatilimab, Syndax's anti-CSF-1R monoclonal antibody.
Sep 23, 2021 07:30 am ET
Knight Therapeutics Enters into Exclusive Supply and Distribution Agreement with Incyte for Tafasitamab and Pemigatinib in Latin America
Knight Therapeutics Inc. (TSX: GUD) (“Knight”), a pan-American (ex-USA) specialty pharmaceutical company, today announced that it has entered into a definitive agreement with Incyte Biosciences International Sàrl, the Swiss-based affiliate of...
Sep 22, 2021 12:38 pm ET
Incyte Announces FDA Approval of Jakafi® (ruxolitinib) for Treatment of Chronic Graft-Versus-Host Disease (GVHD)
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi® (ruxolitinib) for treatment of chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Sep 21, 2021 04:13 pm ET
Incyte Announces U.S. FDA Approval of Opzelura™ (ruxolitinib) Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis (AD)
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States. Research shows dysregulation of the JAK-STAT pathway contributes to key features
Sep 17, 2021 04:00 pm ET
Incyte Announces Health Canada Conditional Approval of Pemazyre® (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarc
MONTREAL, Sept. 17, 2021 /CNW/ - Incyte (NASDAQ: INCY) today announced that Health Canada has granted a Notice of Compliance with conditions for Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
Sep 13, 2021 04:30 pm ET
Incyte Announces Ruxolitinib Cream Data Accepted for Presentation at the 2021 European Academy of Dermatology and Venereology (EADV) Virtual Congress
Incyte (Nasdaq:INCY) today announced that multiple abstracts highlighting data for ruxolitinib cream, an investigational topical JAK1/JAK2 inhibitor, in patients with vitiligo and atopic dermatitis (AD) will be presented at the upcoming European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress, held virtually from September 29-October 2, 2021.
Aug 26, 2021 04:01 pm ET
Incyte and MorphoSys Announce the European Commission Approval of Minjuvi® (tafasitamab) in Combination With Lenalidomide for the Treatment of Adults With Relapsed or Refractory Diffuse Large B-Cell L
Incyte (Nasdaq:INCY) and MorphoSys AG (FSE:MOR; NASDAQ:MOR) today announced that the European Commission (EC) has granted conditional marketing authorization for Minjuvi® (tafasitamab) in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). The EC decision follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2021 recommending
Aug 24, 2021 08:30 am ET
Incyte Announces Health Canada Approval of Minjuvi® (tafasitamab) in Combination with Lenalidomide for the Treatment of Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- Minjuvi is an important new therapeutic option for eligible patients with DLBCL in Canada, addressing an urgent unmet medical need
Aug 17, 2021 08:00 am ET
Incyte to Present at Upcoming Investor Conference
Incyte (Nasdaq:INCY) announced today that it will present at the Morgan Stanley 19th Annual Global Healthcare Conference (Virtual) on Monday, September 13, 2021 at 11:45 a.m. ET.
Aug 16, 2021 07:00 pm ET
Incyte and InnoCare Announce Collaboration and License Agreement for Tafasitamab in Greater China
Incyte (NASDAQ:INCY) and InnoCare (HKEX: 09969) today announced that Incyte and a subsidiary of InnoCare have entered into a collaboration and license agreement for the development and commercialization of tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in Greater China.
Aug 03, 2021 07:00 am ET
Incyte Reports 2021 Second Quarter Financial Results and Provides Updates on Key Clinical Programs
Incyte (Nasdaq:INCY) today reports 2021 second quarter financial results and provides a status update on the Company’s development portfolio.
Aug 03, 2021 06:00 am ET
Lilly and Incyte's baricitinib reduced deaths among patients with COVID-19 receiving invasive mechanical ventilation
INDIANAPOLIS, Aug. 3, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today results from an additional cohort of 101 adult patients from the COV-BARRIER trial. In this sub-study, patients with COVID-19 on mechanical ventilation or extracorporeal membrane oxygenation (ECMO) who received baricitinib plus standard of care were 46 percent less likely to die by Day 28 compared to patients who received placebo plus standard of care (nominal p-value=0.0296; hazard ratio [HR] [95% CI] = 0.54 [0.31, 0.96]; analysis not adjusted for multiplicity). The cumulati
Jul 23, 2021 04:30 pm ET
Incyte Provides Regulatory Update on Retifanlimab for the Treatment of Certain Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)
Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy.
Jul 15, 2021 08:00 am ET
Incyte to Report Second Quarter Financial Results
Incyte (Nasdaq:INCY) announced today that it has scheduled its second quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, August 3, 2021.
Jul 14, 2021 05:00 pm ET
Incyte Announces Positive Phase 3 REACH3 Study Data Published in NEJM for Ruxolitinib (Jakafi®) in Chronic Graft-Versus-Host Disease
Incyte (Nasdaq:INCY) today announced that positive data from the Phase 3 REACH3 study have been published in The New England Journal of Medicine (NEJM) demonstrating that treatment with ruxolitinib (Jakafi®) resulted in significantly improved outcomes in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GVHD) compared to best available therapy (BAT)1. The study’s main findings, previously presented at the 62nd American Society of Hematology (ASH) Annual Meeting, were published along with new subgroup analyses showing favorable
Jun 25, 2021 07:42 am ET
Incyte and MorphoSys Announce Positive CHMP Opinion for Tafasitamab in Combination with Lenalidomide for the Treatment of Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Incyte (Nasdaq:INCY) and MorphoSys AG (FSE:MOR; NASDAQ:MOR) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT).
Jun 24, 2021 03:30 pm ET
Incyte Announces Outcome of FDA Oncologic Drugs Advisory Committee (ODAC) Meeting Reviewing Retifanlimab as a Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)
Incyte (Nasdaq:INCY) today announced the outcome of a meeting of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA), which reviewed the Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The Committee voted 13-4 that a regulatory decision on retifanlimab for the treatment of advanced or metastatic SCAC should be de
Jun 12, 2021 05:01 pm ET
Incyte Announces Updated Data for Ruxolitinib Cream Accepted for Presentation at the 2021 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference
Incyte (Nasdaq:INCY) today announced that multiple abstracts highlighting updated data for ruxolitinib cream, an investigational topical JAK1/JAK2 inhibitor, in patients with atopic dermatitis (AD) will be presented at the upcoming 2021 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference, held on June 13, 2021.
Jun 11, 2021 07:30 am ET
Incyte Announces U.S. FDA Has Extended the New Drug Application Review Period for Ruxolitinib Cream for the Treatment of Atopic Dermatitis
Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for ruxolitinib cream for the treatment of atopic dermatitis (AD). The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to September 21, 2021.
Jun 08, 2021 07:30 am ET
Incyte Announces U.S. FDA Has Extended the sNDA Review Period for Ruxolitinib (Jakafi®) in Chronic Graft-Versus-Host Disease (GVHD)
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi®) for the treatment of adult and pediatric patients 12 years and older with steroid-refractory chronic graft-versus-host disease (GVHD). The new Prescription Drug User Fee Act (PDUFA) target action date is September 22, 2021.
Jun 04, 2021 02:00 pm ET
MorphoSys and Incyte Announce Three-Year Results from Phase 2 L-MIND Study of Tafasitamab in Combination with Lenalidomide for the Treatment of Relapsed or Refractory DLBCL
Presentation will be available on demand as part of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting
Jun 04, 2021 01:45 pm ET
Incyte and MorphoSys Announce Three-Year Results from Phase 2 L-MIND Study of Tafasitamab in Combination with Lenalidomide for the Treatment of Relapsed or Refractory DLBCL
Incyte (NASDAQ:INCY) and MorphoSys US Inc., a fully owned subsidiary of MorphoSys AG (FSE: MOR; NASDAQ:MOR), today announced new three-year follow-up data from the ongoing Phase 2 L-MIND study of tafasitamab (Monjuvi®) in combination with lenalidomide in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). A total of 80 out of 81 enrolled study patients receiving tafasitamab plus lenalidomide were included in the efficacy analysis at approximately three years follow-up (≥35 months)1. The long-term analysis, as assessed by an indepen
May 20, 2021 08:00 am ET
Incyte to Present at Upcoming Investor Conferences
Incyte (Nasdaq:INCY) announced today that it will present at the following investor conferences during the month of June:
May 20, 2021 06:00 am ET
Positive Primary Analysis from the Phase 2 OPTIC Study of Ponatinib (Iclusig®) in Chronic Phase-Chronic Myeloid Leukemia (CP-CML) to be Presented at the 2021 ASCO Annual Meeting
Incyte (Nasdaq:INCY) today announced that data from the primary analysis of the Phase 2 OPTIC (Optimizing Ponatinib Treatment In CML) trial will be presented during an oral session (Abstract #7000) at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, held virtually June 4-8, 2021. The OPTIC trial – an ongoing, randomized, open-label study prospectively evaluating response-based dosing regimens of ponatinib (Iclusig®) over a range of three starting doses (45mg, 30mg, 15mg) followed by dose reduction to 15mg with the aim of optimi
May 19, 2021 05:14 pm ET
Data from Incyte’s Oncology Portfolio Accepted for Presentation at the 2021 ASCO Annual Meeting
Incyte (Nasdaq: INCY) today announced that multiple abstracts highlighting data from its oncology portfolio will be presented during the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, held virtually from June 4-8, 2021.
May 17, 2021 07:30 am ET
Incyte Announces Positive Results from Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream in Patients with Vitiligo
Incyte (Nasdaq:INCY) today announced positive topline results from its pivotal Phase 3 TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream, an investigational, nonsteroidal, anti-inflammatory, JAK inhibitor, topical therapy, in adolescent and adult patients (age ≥12 years) with vitiligo.
May 12, 2021 04:18 pm ET
Data From Incyte’s Oncology Portfolio Accepted for Presentation at the 2021 EHA Virtual Congress
Incyte (Nasdaq:INCY) today announced that multiple abstracts highlighting data from its oncology portfolio will be presented during the upcoming European Hematology Association (EHA) 2021 Virtual Congress, held virtually from June 9-17, 2021.
May 11, 2021 04:01 pm ET
Incyte and MorphoSys Announce First Patient Dosed in Phase 3 frontMIND Study Evaluating Tafasitamab Combination as a First-Line Treatment for Diffuse Large B-Cell Lymphoma
Incyte (NASDAQ:INCY) and MorphoSys AG (FSE:MOR; NASDAQ:MOR) today announced that the first patient has been dosed in the pivotal Phase 3 frontMIND study evaluating tafasitamab and lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) compared to R-CHOP alone as first-line treatment for high-intermediate and high-risk patients with untreated diffuse large B-cell lymphoma (DLBCL). Tafasitamab is a humanized, monoclonal antibody designed to effectively target the B-cell specific antigen CD19 and to induce immune cell activation.
May 04, 2021 07:00 am ET
Incyte Reports 2021 First Quarter Financial Results and Provides Updates on Key Clinical Programs
Incyte (Nasdaq: INCY) today reports 2021 first quarter financial results, and provides a status update on the Company’s development portfolio.
May 03, 2021 08:00 am ET
Incyte Announces Data on Ruxolitinib Cream in Atopic Dermatitis Accepted for Presentation at the Society for Investigative Dermatology (SID) Virtual Meeting 2021
Incyte (Nasdaq:INCY) today announced that multiple abstracts from its dermatology portfolio highlighting data on ruxolitinib cream, a selective JAK1/JAK2 inhibitor designed for topical application, in patients with atopic dermatitis (AD) will be presented at the Society for Investigative Dermatology (SID) Virtual Meeting 2021, held virtually from May 3-8, 2021.
Apr 27, 2021 08:00 am ET
Incyte to Present at Upcoming Investor Conference
Incyte (Nasdaq:INCY) announced today that it will present at the Bank of America Securities Virtual 2021 Healthcare Conference on Thursday, May 13, 2021 at 12:30 p.m. ET.
Apr 23, 2021 10:00 am ET
Incyte Announces New Findings from a Randomized Phase 2 Study of Ruxolitinib Cream in Patients with Vitiligo
Incyte (Nasdaq:INCY) today announced findings from two analyses of its randomized, dose-ranging, vehicle-controlled Phase 2 study evaluating ruxolitinib cream, an investigational nonsteroidal, anti-inflammatory, JAK inhibitor therapy, in adult patients with vitiligo. These presentations (Poster #27535 and #27568) will be available on demand as part of the American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX), held virtually from April 23–25, 2021.
Apr 23, 2021 10:00 am ET
Incyte Announces New Findings from Pooled Analyses of the Phase 3 TRuE-AD Program Evaluating Ruxolitinib Cream in Patients with Atopic Dermatitis
Incyte (Nasdaq:INCY) today announced findings from three pooled analyses of its randomized, double-blind, vehicle-controlled Phase 3 studies – TRuE-AD1 and TRuE-AD2 – evaluating ruxolitinib cream, an investigational JAK1/JAK2 inhibitor designed for topical application, as a treatment for patients with atopic dermatitis (AD). These presentations (Posters #27716, #27620 and #26887) will be available on demand as part of the American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX), held virtually April 23–25, 2021.
Apr 20, 2021 08:00 am ET
Multiple Abstracts from Incyte’s Dermatology Portfolio Accepted for Presentation at the AAD Virtual Meeting Experience
Incyte (Nasdaq:INCY) today announced that multiple abstracts highlighting data from its dermatology portfolio will be presented at the upcoming American Academy of Dermatology Virtual Meeting Experience (AAD VMX), held virtually from April 23-25, 2021.
Apr 19, 2021 04:01 pm ET
Incyte and MorphoSys Announce First Patient Dosed in Phase 3 inMIND Study Evaluating the Addition of Tafasitamab to Lenalidomide and Rituximab in Relapsed or Refractory Follicular or Marginal Zone Lym
Incyte (Nasdaq:INCY) and MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) today announced the first patient has been dosed in the placebo-controlled Phase 3 inMIND study evaluating the efficacy and safety of tafasitamab or placebo in combination with lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL).
Apr 13, 2021 08:00 am ET
Incyte to Report First Quarter Financial Results
Incyte (Nasdaq:INCY) announced today that it has scheduled its first quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, May 4, 2021.
Mar 29, 2021 12:04 pm ET
Incyte Announces the European Commission Approval of Pemazyre® (pemigatinib) as a Treatment for Adults with Locally Advanced or Metastatic Cholangiocarcinoma with a Fibroblast Growth Factor Receptor 2
Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has approved Pemazyre® (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. The decision follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use in January 2021 recommending the conditional marketing authorization of Pemazyre.
Mar 23, 2021 05:13 am ET
Incyte Announces Approval of Pemazyre® (pemigatinib) in Japan for the Treatment of Patients with Unresectable Biliary Tract Cancer (BTC) with a Fibroblast Growth Factor Receptor 2 (FGFR2) Fusion Gene,
Incyte (Nasdaq:INCY) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene1, worsening after cancer chemotherapy.
Mar 18, 2021 04:30 pm ET
Incyte Announces Results from the Phase 3 DEVENT Study Evaluating Ruxolitinib (Jakafi®) as a Treatment for Patients with COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS) on Mechanical Ve
Incyte (Nasdaq:INCY) today announced results from the Phase 3 DEVENT study evaluating the efficacy and safety of ruxolitinib (5mg and 15mg) plus standard of care (SoC) versus SoC in patients on mechanical ventilation with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS), a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs.
Mar 11, 2021 08:00 am ET
Incyte Announces Data from Multiple Programs Within its Oncology Portfolio Accepted for Presentation at the AACR Annual Meeting 2021
Incyte (Nasdaq:INCY) today announced that multiple abstracts from across its oncology portfolio will be presented during Week 1 of the upcoming American Association for Cancer Research (AACR) Annual Meeting 2021, held virtually from April 10-15, 2021.
Feb 26, 2021 03:00 am ET
Incyte Announces the Validation by the European Medicines Agency of its Marketing Authorization Application for Retifanlimab as a Treatment for Patients with Squamous Cell Anal Carcinoma (SCAC)
Incyte (Nasdaq:INCY) today announced the validation of the Company’s Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.
Feb 22, 2021 08:00 am ET
Incyte Announces Acceptance and Priority Review of sNDA for Jakafi® (ruxolitinib) as a Treatment for Patients with Chronic Graft-Versus-Host Disease
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi®) for treatment of steroid-refractory chronic graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.
Feb 19, 2021 08:00 am ET
Incyte Announces Acceptance and Priority Review of NDA for Ruxolitinib Cream for Atopic Dermatitis
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ruxolitinib cream, a selective JAK1/JAK2 inhibitor designed for topical application, as a treatment for atopic dermatitis (AD), a type of eczema.
Feb 11, 2021 08:00 am ET
Incyte to Present at Upcoming Investor Conference
Incyte (Nasdaq:INCY) announced today that it will present at the virtual Cowen 41st Annual Health Care Conference on Wednesday, March 3, 2021 at 2:00 p.m. EST.
Feb 09, 2021 07:00 am ET
Incyte Reports 2020 Fourth Quarter and Year-End Financial Results, Provides 2021 Financial Guidance and Updates on Key Clinical Programs
Incyte (Nasdaq: INCY) today reports 2020 fourth quarter and full year financial results, and provides a status update on the Company’s development portfolio.
Jan 29, 2021 01:36 pm ET
Incyte Announces Positive CHMP Opinion for Pemigatinib for the Treatment of Adults With Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma With a Fibroblast Growth Fact
Incyte (Nasdaq:INCY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that is relapsed or refractory, after at least one line of systemic therapy.
Jan 21, 2021 04:30 pm ET
Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy.
Jan 19, 2021 08:00 am ET
Incyte to Report Fourth Quarter and Year-End 2020 Financial Results
Incyte (Nasdaq:INCY) announced today that it has scheduled its fourth quarter and year-end 2020 financial results conference call and webcast for 8:00 a.m. ET on Tuesday, February 9, 2021.
Jan 12, 2021 03:00 pm ET
Incyte and MorphoSys Announce Acceptance by Health Canada of the New Drug Submission for Tafasitamab
MONTREAL and PLANEGG/MUNICH, Germany, Jan. 12, 2021 /CNW/ - Incyte (NASDAQ: INCY) and MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) today announced that Health Canada has accepted the New Drug Submission (NDS) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologo
Dec 30, 2020 07:30 am ET
Incyte and Cellenkos Enter into Global Development Collaboration Agreement for CK0804
Incyte (Nasdaq:INCY) and Cellenkos, Inc., a privately held, clinical stage biotech company, today announced a development collaboration to investigate the combination of ruxolitinib (Jakafi®) and CK0804, Cellenkos’ cryopreserved CXCR4 enriched, allogeneic, umbilical cord blood-derived T-regulatory cells, in patients with myelofibrosis (MF). In addition, Incyte has an exclusive option to acquire sole rights to develop and commercialize CK0804, and genetically-modified variants of CK0804, in benign and malignant hematology indications.
Dec 14, 2020 01:15 am ET
Incyte Announces Results of Phase 3 RUXCOVID Study of Ruxolitinib (Jakafi®) as a Treatment for Patients with COVID-19 Associated Cytokine Storm
Incyte (Nasdaq:INCY) today announced that the Phase 3 RUXCOVID study evaluating the safety and efficacy of ruxolitinib (Jakafi®), a JAK1/JAK2 inhibitor, plus standard-of-care (SoC) as a treatment for patients 12 years and older with COVID-19 associated cytokine storm did not meet its primary endpoint. Initial data show that there was no reduction in the proportion of patients receiving ruxolitinib plus SoC who experienced severe complications including death, respiratory failure requiring mechanical ventilation or admission to the intensive care unit (ICU) care by Day 29, compared t
Dec 11, 2020 01:01 pm ET
Data from ACTT-2 Trial of Baricitinib in Hospitalized COVID-19 Patients Supportive of the EUA Published in New England Journal of Medicine
INDIANAPOLIS, Dec. 11, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today that The New England Journal of Medicine has published peer-reviewed results from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The Phase 3 study included 1,033 patients from 67 trial sites in eight countries. These results support the emergency use authorization (EUA) issued by the U.S. Food and Drug Administration (FDA) on Nov. 19 for baricitin
Dec 09, 2020 08:00 am ET
Incyte to Present at Upcoming Investor Conference
Incyte (Nasdaq:INCY) announced today that it will present at the 39th Annual J. P. Morgan Virtual Healthcare Conference on Monday, January 11, 2021 at 7:30 a.m. EST.
Dec 07, 2020 10:00 am ET
Data Evaluating Tafasitamab with and without Lenalidomide in Combination with R-CHOP in Patients with DLBCL Presented at ASH 2020
Incyte (Nasdaq:INCY) and MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) announce that preliminary data from firstMIND, the ongoing Phase 1b, open-label, randomized study on the safety and efficacy of tafasitamab or tafasitamab plus lenalidomide in addition to R-CHOP for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) were presented today during the 62nd American Society of Hematology Annual Meeting & Exposition (ASH). Additionally, a long-term subgroup analysis of the L-MIND study investigating tafasitamab combined with lenalido
Dec 07, 2020 10:00 am ET
Incyte Announces Parsaclisib Treatment Results in High Rate of Rapid and Durable Responses in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
Incyte (Nasdaq:INCY) today announced data from three ongoing Phase 2 studies evaluating parsaclisib, a potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), for the treatment of patients with relapsed or refractory follicular (CITADEL-203), marginal zone (CITADEL-204) and mantle cell (CITADEL-205) lymphomas. These data were accepted for presentation at the 62nd American Society of Hematology Annual Meeting and Exposition (ASH 2020), held virtually from December 5–8, 2020.
Dec 04, 2020 12:30 pm ET
Incyte Announces First Data from REACH3 Trial Showing Ruxolitinib (Jakafi®) Significantly Improved Outcomes in Patients with Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease
Incyte (Nasdaq:INCY) today announced that detailed results from the pivotal Phase 3 REACH3 study demonstrate Jakafi® (ruxolitinib) significantly improved outcomes across a range of efficacy measures in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GVHD) compared to best available therapy (BAT)1. The results of REACH3, the first successful, randomized Phase 3 trial in chronic GVHD, were highlighted in a press briefing today and will be presented during the 62nd American Society of Hematology Annual Meeting & Exposition
Nov 19, 2020 04:20 pm ET
Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19
INDIANAPOLIS, Nov. 19, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the distribution and emergency use of baricitinib to be used in combination with remdesivir in hospitalized adult and pediatric patients two years of age or older with suspected or laboratory confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Nov 12, 2020 08:00 am ET
Incyte to Present at Upcoming Investor Conference
Incyte (Nasdaq:INCY) announced today that it will present at the 3rd Annual Evercore ISI Virtual HealthCONx Conference on Tuesday, December 1, 2020 at 10:30 a.m. EST.
Nov 11, 2020 04:02 pm ET
Xencor, MorphoSys and Incyte Enter into Global Development Collaboration for Tafasitamab in Combination with Plamotamab
Xencor (NASDAQ: XNCR), MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) and Incyte (NASDAQ: INCY) today announced a clinical collaboration to investigate the combination of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), first-line DLBCL, and relapsed or refractory follicular lymphoma (FL).
Nov 09, 2020 08:00 am ET
Data from Incyte’s Oncology Portfolio Accepted for Presentation at the Society for Immunotherapy of Cancer 2020 Annual Meeting
Incyte (Nasdaq:INCY) today announced that abstracts highlighting data from its oncology portfolio will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, held virtually from November 11-14, 2020.
Nov 05, 2020 07:00 am ET
Incyte Reports 2020 Third Quarter Financial Results and Provides Updates on Key Clinical Programs
Incyte (Nasdaq: INCY) today reports 2020 third quarter financial results, and provides a status update on the Company’s development portfolio.
Nov 04, 2020 03:55 pm ET
More than 40 Abstracts from Incyte’s Oncology Portfolio Accepted for Presentation at the 62nd Annual ASH Virtual Meeting
Incyte (Nasdaq: INCY) today announced that numerous abstracts highlighting data from its oncology portfolio will be presented at the upcoming 62nd American Society of Hematology Annual Meeting and Exposition (ASH 2020), held virtually December 5–8, 2020.
Nov 02, 2020 01:00 pm ET
ACR 2020: Lilly and Incyte Highlight Positive Data for Olumiant® in Rheumatoid Arthritis
INDIANAPOLIS, Nov. 2, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today positive data for Olumiant® (baricitinib) will be presented at ACR Convergence 2020, the American College of Rheumatology's virtual annual meeting taking place November 5-9, 2020. The Olumiant data being presented at this year's meeting include new long-term studies in adult patients living with rheumatoid arthritis (RA), along with real-world evidence (RWE) on safety and efficacy.
Oct 31, 2020 10:45 am ET
EADV 2020: Lilly and Incyte Showcase New Data for Baricitinib for the Treatment of Moderate to Severe Atopic Dermatitis
INDIANAPOLIS, Oct. 31, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib will be presented at the 29th annual European Academy of Dermatology and Venereology (EADV) Congress taking place virtually October 29-31, 2020. The data reinforce Lilly's commitment to developing medicines for the treatment of dermatologic diseases such as moderate to severe atopic dermatitis (AD). AD—also known as eczema—is a chronic inflammatory skin disorder that causes intense skin itching, redness, rash and sores.
Oct 30, 2020 09:00 am ET
Incyte Ranked Second Among Science Magazine’s 2020 Top Biopharma Employers
Incyte (Nasdaq:INCY) today announced that the company has again been named a top biopharma employer by Science magazine through its Top Employers Survey of the global pharmaceutical and biotech industry. This year, Incyte ranked second, marking the third consecutive year the company has been included in the top three on this prestigious industry list.
Oct 30, 2020 06:45 am ET
Fall Clinical Dermatology 2020: Lilly and Incyte Showcase Positive New Data for Baricitinib in Adult Patients with Alopecia Areata
INDIANAPOLIS, Oct. 30, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib (marketed as OLUMIANT®) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020. The data underscore Lilly's commitment to providing medicines for dermatologic diseases that have high unmet need, including alopecia areata (AA). AA is an autoimmune disorder that can cause unpredictable hair loss on the scalp, face and other areas of the body.
Oct 29, 2020 08:00 am ET
Pooled Results from Incyte’s TRuE-AD1 and TRuE-AD2 Atopic Dermatitis Studies of Ruxolitinib Cream Show Clinically Meaningful Improvements in Patient-Reported Quality of Life Assessments
Incyte (Nasdaq:INCY) today announced efficacy and safety results from a pooled analysis of two randomized, double-blind, vehicle-controlled Phase 3 studies – TRuE-AD1 and TRuE-AD2 – evaluating ruxolitinib cream for the treatment of patients with mild-to-moderate atopic dermatitis (AD). The presentation (FC08.08) will be available on-demand as part of the 29th European Academy of Dermatology and Venereology (EADV) Congress, held virtually from October 29-31, 2020.
Oct 26, 2020 09:00 am ET
Incyte Announces Health Canada Acceptance of the New Drug Submission for Pemigatinib as a Treatment for Patients with Cholangiocarcinoma
MONTREAL, Oct. 26, 2020 /CNW/ - Incyte (Nasdaq: INCY) today announced that Health Canada has accepted its New Drug Submission (NDS) for pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor, as a treatment for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or other rearrangement.
Oct 20, 2020 08:00 am ET
Incyte to Report Third Quarter Financial Results
Incyte (Nasdaq:INCY) announced today that it has scheduled its third quarter financial results conference call and webcast for 8:00 a.m. ET on Thursday, November 5, 2020.
Oct 05, 2020 12:00 pm ET
Nimble Announces Strategic Research Collaboration with Incyte to Discover Novel Peptide-Based Therapeutics
Nimble Therapeutics Inc. today announced the company has entered into a strategic collaboration with Incyte (NASDAQ: INCY) to discover first-in-class peptide therapies across various disease areas.
Sep 18, 2020 06:00 am ET
Incyte Announces Encouraging Results From Phase 2 Trial of Retifanlimab (INCMGA0012) in Patients With Previously Treated, Advanced Squamous Cell Carcinoma of the Anal Canal
Incyte (Nasdaq:INCY) today announced results from its Phase 2 POD1UM-202 trial evaluating retifanlimab, a PD-1 inhibitor, in previously treated patients with advanced squamous cell carcinoma of the anal canal (SCAC) who have progressed following standard platinum-based chemotherapy. The trial enrolled 94 patients, including those with well-controlled human immunodeficiency virus (HIV) infection (10%).
Sep 17, 2020 04:03 pm ET
Incyte and MorphoSys to Host Investor Event to Discuss the Unmet Need and Global Opportunities for Tafasitamab in Non-Hodgkin Lymphomas
Incyte (Nasdaq:INCY) and MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) today announced that the companies intend to host a conference call and webcast to discuss global development, unmet need and commercial opportunities for tafasitamab.
Sep 09, 2020 10:05 am ET
Incyte Announces Recipient of the Inaugural Incyte Ingenuity Award to Recognize Innovative Solutions that Address Needs in the GVHD Community
Incyte (Nasdaq:INCY) today announced that Massachusetts General Cancer Center is the recipient of the first Incyte Ingenuity Award, an annual program that was created to support people living with graft-versus-host disease (GVHD) by encouraging innovative and novel solutions that address specific challenges facing the GVHD community.
Sep 02, 2020 05:04 pm ET
Incyte Announces Pivotal GEOMETRY mono-1 Study Results of Capmatinib (Tabrecta™) in Patients with METex14 Metastatic Non-Small Cell Lung Cancer Published in NEJM
Incyte (Nasdaq: INCY) today announced that data from the Novartis pivotal Phase 2 GEOMETRY mono-1 study demonstrating that treatment with Tabrecta™ (capmatinib) resulted in positive overall response rates (ORR) with durable responses among adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to skipping of MET exon 14 (METex14) have been published in The New England Journal of Medicine.1
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