Incyte

DGAP-News: FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Saturday, August 1, 2020 - 1:00am

The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.

Key Points: 
  • The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.
  • "The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States," said Herv Hoppenot, Chief Executive Officer, Incyte.
  • "Today's FDA decision offers new hope for patients with this aggressive form of DLBCL who progressed during or after first-line therapy."
  • The FDA previously granted Fast Track and Breakthrough Therapy Designation for the combination of Monjuvi and lenalidomide in relapsed or refractory DLBCL.

FDA Approves Monjuvi® (tafasitamab-cxix) in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Saturday, August 1, 2020 - 12:51am

The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.

Key Points: 
  • The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.
  • The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States, said Herv Hoppenot, Chief Executive Officer, Incyte.
  • The FDA approval was based on data from the MorphoSys-sponsored Phase 2 L-MIND study, an open label, multicenter, single arm trial of Monjuvi in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL.
  • The FDA previously granted Fast Track and Breakthrough Therapy Designation for the combination of Monjuvi and lenalidomide in relapsed or refractory DLBCL.

Incyte Announces REACH3 Trial of Ruxolitinib (Jakafi®) in Patients with Chronic Graft-Versus-Host Disease Met Primary and Both Key Secondary Endpoints

Thursday, July 23, 2020 - 12:15pm

In addition, the study also met both key secondary endpoints, significantly improving failure-free survival (FFS) and patient-reported symptoms assessed by the modified Lee chronic GVHD symptom scale (mLSS).

Key Points: 
  • In addition, the study also met both key secondary endpoints, significantly improving failure-free survival (FFS) and patient-reported symptoms assessed by the modified Lee chronic GVHD symptom scale (mLSS).
  • The primary endpoint was overall response rate (ORR) at Day 1 of the Cycle 7 (Day 168) visit, defined as the percentage of participants demonstrating a complete or partial response.
  • The REACH clinical trial program evaluating ruxolitinib in patients with steroid-refractory GVHD includes the randomized pivotal Phase 3 REACH2 and REACH3 trials, conducted in collaboration with Novartis.
  • Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States.

Incyte to Report Second Quarter Financial Results

Thursday, July 16, 2020 - 1:00pm

The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international callers is 201-612-7415.

Key Points: 
  • The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international callers is 201-612-7415.
  • The live webcast with slides can be accessed at Investor.Incyte.com and will be available for replay for 90 days.
  • Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.
  • For additional information on Incyte, please visit Incyte.com and follow @Incyte .

Incyte Announces Approval of Tabrecta™ (capmatinib) in Japan for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with METex14

Monday, June 29, 2020 - 12:05pm

Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type.

Key Points: 
  • Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type.
  • Tabrecta is the third Incyte-discovered medicine to receive approval in Japan.
  • Approval of Tabrecta in Japan triggers a $20 million milestone payment to Incyte, and Incyte is also eligible to receive 12-14% royalties on global net sales of Tabrecta by Novartis.
  • This approval highlights the strength of the Incyte in-house discovery program, and our commitment to finding solutions for serious medical needs.

Incyte Investor Conference Update

Wednesday, June 17, 2020 - 1:00pm

Incyte (Nasdaq:INCY) has updated its presentation time at the following investor conference:

Key Points: 
  • Incyte (Nasdaq:INCY) has updated its presentation time at the following investor conference:
    JMP Securities Hematology & Oncology Forum (Virtual) on Thursday, June 18, 2020, now at 3:00 p.m. (EDT).
  • The presentation at the BMO Prescriptions for Success Healthcare Conference (Virtual) on Tuesday, June 23, 2020 at 1:30 p.m. (EDT) is unchanged.
  • Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.
  • For additional information on Incyte, please visit Incyte.com and follow @Incyte .

Incyte Launches New Global Responsibility Section on Incyte.com

Monday, June 15, 2020 - 1:00pm

Incyte (Nasdaq:INCY) today announced that a new Global Responsibility section has been launched as part of Incyte.com.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced that a new Global Responsibility section has been launched as part of Incyte.com.
  • In addition, and as part of this newly available content, Incyte has also released its first annual Sustainable Accounting Standards Board ( SASB) Summary as well as a summary of 2019 Global Responsibility Highlights .
  • We are proud to have formalized our Global Responsibility initiative.
  • Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.

Incyte to Present at Upcoming Investor Conferences

Wednesday, June 3, 2020 - 1:00pm

Incyte (Nasdaq:INCY) announced today that it will present at the following investor conferences during the month of June:

Key Points: 
  • Incyte (Nasdaq:INCY) announced today that it will present at the following investor conferences during the month of June:
    Goldman Sachs 41st Annual Global Healthcare Conference (Virtual) on Tuesday, June 9, 2020 at 8:00 am (EDT);
    JMP Securities Hematology & Oncology Forum (Virtual) on Thursday, June 18, 2020 at 4:40 pm (EDT); and
    BMO Prescriptions for Success Healthcare Conference (Virtual) on Tuesday, June 23, 2020 at 1:30 pm (EDT)
    The presentations will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.
  • Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.
  • For additional information on Incyte, please visit Incyte.com and follow @Incyte .
  • View source version on businesswire.com: https://www.businesswire.com/news/home/20200603005070/en/

Incyte to Present at Upcoming Investor Conference

Thursday, May 21, 2020 - 1:00pm

Incyte (Nasdaq:INCY) announced today that it will present at the Goldman Sachs 41st Annual Global Healthcare Conference (held virtually) on Tuesday, June 9, 2020 at 8:00 a.m.

Key Points: 
  • Incyte (Nasdaq:INCY) announced today that it will present at the Goldman Sachs 41st Annual Global Healthcare Conference (held virtually) on Tuesday, June 9, 2020 at 8:00 a.m.
  • The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.
  • Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.
  • For additional information on Incyte, please visit Incyte.com and follow @Incyte .

Incyte and MorphoSys Announce the Validation of the European Marketing Authorization Application for Tafasitamab

Wednesday, May 20, 2020 - 7:00pm

Incyte (NASDAQ:INCY) and MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) today announced the validation of the European Marketing Authorization Application (MAA) for tafasitamab, an anti-CD19 antibody.

Key Points: 
  • Incyte (NASDAQ:INCY) and MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) today announced the validation of the European Marketing Authorization Application (MAA) for tafasitamab, an anti-CD19 antibody.
  • Following the U.S. FDAs acceptance of our Biologics License Application filing for tafasitamab for Priority Review earlier this year, this represents another major step forward.
  • If approved, Incyte will hold the marketing authorization, and has exclusive commercialization rights for tafasitamab outside of the United States, including Europe.
  • In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally.