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.
“In the first quarter, we continued to make significant progress in our strategy to drive growth and diversification. While Jakafi® (ruxolitinib) net sales were affected by typical seasonal effects and softer patient demand growth due to the ongoing pandemic, we remain confident in our full-year outlook. We are already seeing a return of new patient starts to pre-COVID levels and are excited for the potential launch in steroid-refractory chronic graft-versus-host disease (GVHD) later this year. The launches of Monjuvi® (tafasitamab) and Pemazyre® (pemigatinib) continue to progress with good uptake by both academic and community physicians,” stated Hervé Hoppenot, Chief Executive Officer, Incyte. “We expect an exciting year ahead for Incyte with the potential for multiple approvals, including ruxolitinib cream in atopic dermatitis, and several regulatory filings, notably parsaclisib in NHL and ruxolitinib cream in vitiligo. We are also initiating pivotal trials across key development programs for both tafasitamab and LIMBER this year.”
Portfolio Update
MPNs and GVHD – key highlights
Ruxolitinib in GVHD: The supplemental New Drug Application (sNDA) seeking approval of ruxolitinib for the treatment of steroid-refractory chronic GVHD has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA); the Prescription Drug User Fee Act (PDUFA) date is June 22, 2021. The application for approval was based on the successful randomized REACH3 trial comparing ruxolitinib with best available therapy (BAT).
LIMBER: Our Leadership In MPNs BEyond Ruxolitinib (LIMBER) development program continues to progress with once daily (QD) ruxolitinib in stability testing, and multiple ongoing and planned combination trials with ruxolitinib on track. Both monotherapy trials of INCB57643 (BET) and INCB00928 (ALK2) are ongoing, and combination trials of both agents with ruxolitinib in patients with myelofibrosis (MF) are expected to initiate later this year. Two Phase 3 trials of ruxolitinib in combination with parsaclisib as a first-line therapy for patients with MF (LIMBER-313) and as a therapy for MF patients with a suboptimal response to ruxolitinib monotherapy (LIMBER-304) are ongoing.
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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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