Incyte

68 articles with Incyte

• Incyte Announces U.S. FDA Has Extended the sNDA Review Period for Ruxolitinib (Jakafi®) in Chronic Graft-Versus-Host Disease (GVHD)

  6/8/2021

  Incyte Announces U.S. FDA Has Extended the sNDA Review Period for Ruxolitinib (Jakafi ® ) in Chronic Graft-Versus-Host Disease (GVHD).

• 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

  6/4/2021

  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)

• Data from Incyte’s Oncology Portfolio Accepted for Presentation at the 2021 ASCO Annual Meeting

  5/19/2021

  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.

• Incyte Announces Positive Results from Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream in Patients with Vitiligo

  5/17/2021

  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

• Data From Incyte’s Oncology Portfolio Accepted for Presentation at the 2021 EHA Virtual Congress

  5/12/2021

  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.

• 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

  5/11/2021

  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

• Incyte Reports 2021 First Quarter Financial Results and Provides Updates on Key Clinical Programs

  5/4/2021

    Total product and royalty revenues of $605 million in Q1 2021 (+6% vs Q1   2020) Jakafi ® (ruxolitinib) revenues of $466 million in Q1   2021 (+1% vs Q1   2020); reaffirming full year guidance of $2.125-$2.20 billion Pemazyre ® (pemigatinib) now also approved in Europe and Japan, becoming the first internally discovered product to be globally commercialized by Incyte

• Incyte Announces Data on Ruxolitinib Cream in Atopic Dermatitis Accepted for Presentation at the Society for Investigative Dermatology (SID) Virtual Meeting 2021

  5/3/2021

  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.

• Incyte Announces New Findings from Pooled Analyses of the Phase 3 TRuE-AD Program Evaluating Ruxolitinib Cream in Patients with Atopic Dermatitis

  4/23/2021

  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).

• Incyte Announces New Findings from a Randomized Phase 2 Study of Ruxolitinib Cream in Patients with Vitiligo

  4/23/2021

  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.

• Multiple Abstracts from Incyte’s Dermatology Portfolio Accepted for Presentation at the AAD Virtual Meeting Experience

  4/20/2021

  More than 14 abstracts, including new findings from Incyte’s clinical trial programs for ruxolitinib cream in patients with vitiligo and atopic dermatitis, to be presented

• 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 Lymphoma

  4/19/2021

  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 Lymphoma

• Lilly and Incyte communicate review extension of supplemental New Drug Application for baricitinib for the treatment of moderate to severe atopic dermatitis

  4/6/2021

   Eli Lilly and Company (NYSE: LLY) and Incyte (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 baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD).

• 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 (FGFR2) Fusion or Rearrangement

  3/29/2021

  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.

• Incyte Announces Data from Multiple Programs Within its Oncology Portfolio Accepted for Presentation at the AACR Annual Meeting 2021

  3/11/2021

  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.

• Incyte Reports 2020 Fourth Quarter and Year-End Financial Results, Provides 2021 Financial Guidance and Updates on Key Clinical Programs

  2/9/2021

  - Total FY revenues of $2.67 billion (+24% y/y); total FY product and royalty revenues increased 18% to $2.46 billion; three new FDA approvals in 2020 - Jakafi ® (ruxolitinib) FY revenue increased to $1.94 billion (+15% y/y); Jakafi ® guidance range of $2.125 to $2.20 billion for 2021 - Successful launches of Monjuvi ® (tafasitamab-cxix) and Pemazyre ® (pemigatinib) in the U.S.

• 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 Factor Receptor 2 (FGFR2) Fusion or Rearrangement

  1/29/2021

  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

• 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)

  1/21/2021

  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. Th

• Incyte to Report Fourth Quarter and Year-End 2020 Financial Results

  1/19/2021

  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.

• Incyte and Cellenkos Enter into Global Development Collaboration Agreement for CK0804

  12/30/2020

  - Incyte and Cellenkos will evaluate the combination of ruxolitinib (Jakafi ® ) and CK0804, cord blood-derived T-regulatory cells, in patients with myelofibrosis - Incyte has an exclusive option to acquire sole rights to CK0804