Incyte Reports 2020 Fourth Quarter and Year-End Financial Results, Provides 2021 Financial Guidance and Updates on Key Clinical Programs
Incyte reported robust financial results for Q4 and full year 2020, highlighting strong revenue growth fueled by Jakafi's demand and successful launches of Monjuvi and Pemazyre. The company anticipates regulatory decisions on seven new applications in 2021, including potential FDA approval for ruxolitinib cream by mid-year. Key clinical advancements include ongoing Phase 3 trials for ruxolitinib combined with parsaclisib for myelofibrosis and a new collaboration with Cellenkos for innovative treatments in hematology.
- Strong revenue growth driven by Jakafi, Monjuvi, and Pemazyre.
- Expected FDA approval of ruxolitinib cream mid-2021.
- Seven regulatory applications in progress for 2021.
- Positive results reported from multiple late-stage clinical trials.
- None.
Incyte (Nasdaq: INCY) today reports 2020 fourth quarter and full year financial results, and provides a status update on the Company’s development portfolio.
“Our team achieved many important accomplishments in the past year. Revenue growth was strong, driven by demand for Jakafi® (ruxolitinib), and the launches of Monjuvi® (tafasitamab-cxix) and Pemazyre® (pemigatinib) continue to gain momentum. During 2020, we also announced positive results across multiple late-stage programs, including the pivotal trials of ruxolitinib in chronic GVHD, ruxolitinib cream in atopic dermatitis, parsaclisib in NHL, and retifanlimab in SCAC,” stated Hervé Hoppenot, Chief Executive Officer, Incyte. “During 2021, we expect regulatory decisions on seven applications seeking approval, including four in the U.S, two in Europe and one in Japan, and we are working towards the potential U.S. launch of ruxolitinib cream, which we expect to be approved by the FDA in the middle of the year.”
Portfolio Updates
MPNs and GVHD – key highlights
Our LIMBER development program, to improve patient outcomes in MPNs and GHVD, is progressing well.
The two Phase 3 trials of ruxolitinib in combination with parsaclisib are both underway, evaluating the combination versus monotherapy ruxolitinib as a first-line therapy for patients with myelofibrosis (MF) (LIMBER-313) and as a therapy for MF patients with a suboptimal response to ruxolitinib monotherapy (LIMBER-304).
Monotherapy trials of INCB57643 (BET) and INCB00928 (ALK2) are underway, and are expected to lead to proof-of-concept combination trials of both agents with ruxolitinib in patients with myelofibrosis. A monotherapy trial of itacitinib (JAK1) in patients previously treated with ruxolitinib is ongoing.
In December 2020, Incyte and Cellenkos announced a development collaboration to investigate the combination of ruxolitinib and CK0804, Cellenkos’ cryopreserved CXCR4 enriched, allogeneic, umbilical cord blood-derived T-regulatory cells, in patients with myelofibrosis. In addition, Incyte obtained an exclusive option to acquire sole rights to develop and commercialize CK0804, and genetically-modified variants of CK0804, in benign and malignant hematology indications.
The sNDA seeking approval of Jakafi in steroid-refractory chronic graft-versus-host disease (GVHD) has been submitted, based on data from the successful results of the REACH3 trial, which were presented at ASH 2020.
Indication and status |
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Once-a-day ruxolitinib
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Myelofibrosis, polycythemia vera & GVHD: clinical pharmacology studies |
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ruxolitinib + parsaclisib
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Myelofibrosis: Phase 3 (first-line therapy) (LIMBER-313) Myelofibrosis: Phase 3 (suboptimal responders to ruxolitinib) | |
FAQ
What were Incyte's Q4 2020 financial results?
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