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Incyte Reports 2018 Fourth Quarter and Year-End Financial Results, Provides 2019 Financial Guidance and Provides Updates on Key Clinical Programs

Nachrichtenquelle: Business Wire (engl.)
14.02.2019, 13:00  |  1988   |   |   

Incyte Corporation (Nasdaq:INCY) today reports 2018 fourth quarter and year-end financial results, announces 2019 guidance and provides a status update on the Company’s development portfolio.

“Sales of Jakafi were strong in 2018, which is a testament to its well-established efficacy and safety profile, and we continue to work with the FDA to facilitate the review of the GVHD indication,” stated Hervé Hoppenot, Chief Executive Officer, Incyte. “Our late-stage product portfolio provides us with multiple additional opportunities to accelerate revenue growth. Our submission to the FDA seeking marketing approval of pemigatinib in patients FGFR2 translocated cholangiocarcinoma is expected later this year, as is the submission, by Novartis, for the approval of capmatinib in patients with MET exon-14 skipping non-small cell lung cancer. Results from the pivotal trial of itacitinib in newly-diagnosed GVHD patients are expected later this year, as are the results of two additional pivotal trials of ruxolitinib in patients with steroid-refractory GVHD, as well as proof-of-concept data from the trial of ruxolitinib cream in patients with vitiligo. Success with these product candidates would not only serve to further diversify our sources of revenue, but would also illustrate the productivity of the research and development group at Incyte.”

Portfolio Update

Oncology – key highlights

The U.S. Food and Drug Administration (FDA) recently extended the review of the supplemental New Drug Application (sNDA) seeking approval of ruxolitinib (JAK1/JAK2) for the treatment of steroid-refractory acute GVHD, assigning a new Prescription Drug User Fee Act (PDUFA) date of May 24, 2019. The sNDA is supported by data from REACH1, which were presented at the American Society of Hematology (ASH) Annual Meeting in December. Incyte is prepared for an immediate launch in the U.S. should ruxolitinib be approved in this new indication.

Phase 3 trials of ruxolitinib in patients with steroid-refractory GVHD (REACH2 [acute]; REACH3 [chronic]) are expected to deliver results in the second half of 2019, as is the Phase 3 trial of itacitinib (JAK1) in patients with steroid-naïve acute GVHD (GRAVITAS-301).

The FDA has recently granted pemigatinib (FGFR) Breakthrough Therapy designation for the treatment of previously treated, advanced/metastatic or unresectable FGFR2 translocated cholangiocarcinoma. The FDA’s Breakthrough Therapy designation is designed to expedite the development and review of drugs for serious conditions that have shown encouraging early clinical results and may demonstrate substantial improvements over available medicines.

The New Drug Application (NDA) seeking approval of pemigatinib for the second-line treatment of patients with FGFR2 translocated cholangiocarcinoma is expected to be submitted in the third quarter of 2019, and we are now recruiting patients into a pivotal trial of pemigatinib for the first-line treatment of cholangiocarcinoma. A pivotal program for the first-line treatment of patients with bladder cancer is planned to launch this year. Based on data generated from ongoing trials in patients with FGFR-driven cholangiocarcinoma, bladder cancer and 8p11 MPN, Incyte is planning to initiate a pivotal tumor-agnostic trial evaluating pemigatinib in patients with driver-activations of FGF/FGFR later this year.

Status updates for Incyte’s later-stage clinical programs are provided below.

             
     

Indication

   

Status Update

Ruxolitinib
(JAK1/JAK2)

    Steroid-refractory acute GVHD     sNDA accepted for Priority Review (based on REACH1), review period extended by three months; Phase 3 (REACH2)

Ruxolitinib
(JAK1/JAK2)

Steroid-refractory chronic GVHD Phase 3 (REACH3)

Ruxolitinib
(JAK1/JAK2)

Essential thrombocythemia Phase 2 (RESET)

Ruxolitinib
(JAK1/JAK2)

Refractory myelofibrosis Phase 2 in combination with parsaclisib (PI3Kδ), INCB53914 (PIM) or itacitinib (JAK1)

Itacitinib
(JAK1)

Treatment-naïve acute GVHD Phase 3 (GRAVITAS-301)

Itacitinib
(JAK1)

Treatment-naïve chronic GVHD Phase 3 (GRAVITAS-309)

Itacitinib
(JAK1)

NSCLC Phase 1/2 in combination with osimertinib (EGFR)

Pemigatinib
(FGFR1/2/3)

Bladder cancer Phase 2 (FIGHT-201)

Pemigatinib
(FGFR1/2/3)

Cholangiocarcinoma Phase 2 (FIGHT-202); Phase 3 (FIGHT-302) now recruiting

Pemigatinib
(FGFR1/2/3)

8p11 MPN Phase 2 (FIGHT-203)

Pemigatinib
(FGFR1/2/3)

Solid tumors with driver activations of FGF/FGFR

Pivotal program in preparation

INCMGA0012
(PD-1)
1

Solid tumors Phase 2 trials (MSI-high endometrial cancer, merkel cell carcinoma, anal cancer)

Parsaclisib
(PI3Kδ)

    Non-Hodgkin lymphoma     Phase 2 (CITADEL-203, follicular lymphoma), (CITADEL-204, marginal zone lymphoma), (CITADEL-205, mantle cell lymphoma)
 
Notes:
1) INCMGA0012 licensed from MacroGenics
 

Incyte also has a portfolio of compounds in proof-of-concept trials, as detailed below.

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