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

Rhea-AI Summary

Incyte reports Q1 2021 financial results and a positive outlook despite softer demand for Jakafi due to COVID-19. CEO Hervé Hoppenot highlighted a return to pre-pandemic patient levels and potential launches for new treatments, including ruxolitinib for chronic GVHD and ongoing trials for tafasitamab. The FDA has accepted the sNDA for ruxolitinib in GVHD with a PDUFA date of June 22, 2021. Incyte anticipates multiple regulatory approvals and trial initiations this year, reinforcing its growth strategy.

Positive

• Return of new patient starts for Jakafi to pre-COVID levels.
• FDA accepts ruxolitinib sNDA for chronic GVHD with PDUFA date set.
• Progress in developmental programs for tafasitamab and LIMBER.

Negative

• Jakafi net sales impacted by seasonal effects and softer patient demand growth.

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.

	Indication and status
Once-a-day ruxolitinib (JAK1/JAK2)	Myelofibrosis, polycythemia vera & GVHD: clinical pharmacology studies
ruxolitinib + parsaclisib (JAK1/JAK2 + PI3Kδ)

FAQ

What are Incyte's Q1 2021 financial results?

Incyte reported softer demand for Jakafi in Q1 2021 but remains confident in its full-year outlook.

What is the status of ruxolitinib in chronic GVHD?

The FDA has accepted the sNDA for ruxolitinib for steroid-refractory chronic GVHD, with a PDUFA date of June 22, 2021.

What upcoming product launches and trials does Incyte have?

Incyte plans to launch ruxolitinib for chronic GVHD and has several pivotal trials underway, including for tafasitamab.