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Incyte (Nasdaq:INCY) reported updated Phase 1 data (data cut-off Sep 25, 2025) for INCA033989, a first‑in‑class mutCALR‑targeted monoclonal antibody, in essential thrombocythemia (ET) patients resistant/intolerant to prior cytoreductive therapy.
At higher doses (400–2,500 mg) 90% achieved a hematologic response and 83.3% achieved complete hematologic response (CHR); 46.4% achieved durable (≥12 weeks) CHR. A mutCALR VAF reduction occurred in 96.2% of patients with post‑baseline measurements; 52% had ≥25% VAF reduction and 31% had ≥50% reduction. No dose‑limiting toxicities were observed and the FDA granted Breakthrough Therapy designation for Type 1 CALR ET.
Incyte (Nasdaq:INCY) announced the U.S. FDA granted Breakthrough Therapy designation to INCA033989, a first‑in‑class mutCALR‑targeted monoclonal antibody, for treatment of essential thrombocythemia (ET) patients with a Type 1 CALR mutation who are resistant or intolerant to at least one cytoreductive therapy.
The designation was supported by early Phase 1 data showing INCA033989 was well‑tolerated and produced rapid, durable platelet normalization; updated Phase 1 data and new myelofibrosis results will be presented at ASH 2025 on December 8. Incyte plans to seek regulator alignment and begin a Phase 3 program in mid‑2026 to evaluate patients with all CALR mutation types.
Key context: CALR mutations occur in ~25% of ET patients and Type 1 deletions represent ~55% of CALR mutations.
Incyte (NASDAQ:INCY) reported Phase 1 data for INCA033989, a mutCALR-targeted monoclonal antibody, showing rapid spleen-volume and symptom reductions and anemia improvements in myelofibrosis (data cut-off Sept 25, 2025). As monotherapy (n=36 evaluable at Week 24) SVR25 was 41.7% and SVR35 33.3%; higher responses were seen in JAK‑naïve patients. Anemia response occurred in 56% (14/25) with 40% major responses. Most patients showed reductions in mutCALR VAF and bone marrow mutCALR+ progenitors. No dose‑limiting toxicities; MTD not reached. Registrational program planned for 2026.
Incyte (Nasdaq: INCY) announced inducement equity awards for Richard Hoffman, its new Executive Vice President and General Counsel, with a grant and vesting commencement date of December 1, 2025.
Mr. Hoffman received stock options to purchase 43,301 shares (exercise price $102.04, ten-year term, 25% vest at one year then monthly over 36 months), 9,466 RSUs (25% vest each year for four years) and performance shares with a target of 23,665 (payout 0–200% based on relative TSR over a three-year period beginning January 1, 2025, vesting on the third anniversary, subject to continued service).
Incyte (NASDAQ:INCY) announced on December 2, 2025 a partnership with supermodel and entrepreneur Winnie Harlow to launch “The Power of Choice” campaign to raise awareness of vitiligo.
The campaign features two new videos where Harlow revisits her childhood, shares advice for others living with vitiligo, and encourages people to learn about the condition and discuss options with dermatologists. Incyte said the initiative aims to validate lived experiences and promote patient choice in managing vitiligo. The release directs readers to ThisIsVitiligo.com for more information and notes Winnie Harlow was compensated for participation.
Incyte (Nasdaq:INCY) appointed Richard Hoffman as Executive Vice President and General Counsel effective December 1, 2025. Mr. Hoffman will join the Executive Leadership Team and lead legal and compliance functions.
He brings more than 20 years of experience advising biopharma on corporate governance, strategic transactions, intellectual property and litigation, most recently as a partner in Goodwin's Life Sciences group. Mr. Hoffman has advised companies including Anthos Therapeutics, Compass Therapeutics, Deciphera, PepGen and Syntimmune, and previously held senior roles at Hybridon and Avitech. He holds a B.A. from Harvard, a J.D. from Columbia and an M.B.A. from Wharton.
Mr. Hoffman succeeds Sheila Denton, who will leave to pursue new opportunities and will provide transitional support into the new year.
Incyte (Nasdaq:INCY) will present at investor conferences in December 2025: Citi’s 2025 Global Healthcare Conference on Tuesday, December 2, 2025 at 11:15 AM ET and the 8th Annual Evercore Healthcare Conference on Wednesday, December 3, 2025 at 1:20 PM ET. The presentations will be webcast live at Investor.Incyte.com and replays will be available for 30 days.
Incyte (NASDAQ:INCY) announced a positive CHMP opinion recommending approval of Minjuvi (tafasitamab) with lenalidomide and rituximab for adult patients with relapsed or refractory follicular lymphoma (FL) after ≥1 systemic therapy.
Phase 3 inMIND (n=548) showed median investigator-assessed PFS of 22.4 months vs 13.9 months (HR 0.43; P<0.0001); IRC-assessed median PFS was not reached vs 16.0 months (HR 0.41). Safety was described as manageable; common adverse reactions ≥20% included respiratory infections, diarrhea, rash, and fatigue. The CHMP opinion now goes to the European Commission for a final decision.
Incyte (Nasdaq:INCY) announced on November 6, 2025 the expansion of its Moments of Clarity program to include six new patient stories focused on nonsegmental vitiligo and pediatric mild-to-moderate atopic dermatitis (eczema). The release highlights individual journeys, the role of healthcare engagement, and patient experience with Opzelura (ruxolitinib) cream 1.5%. Opzelura's approved topical uses and age ranges are noted. The program directs audiences to MyMomentsOfClarity.com for multimedia stories; participants were compensated.
Incyte (Nasdaq: INCY) announced that more than 50 abstracts will be presented at the 2025 ASH Annual Meeting (Dec 6–9, 2025) in Orlando, highlighting clinical and translational data across MPNs, GVHD and other hematology programs.
Key highlights: oral presentations for the first‑in‑class mutCALR antibody INCA033989 (monotherapy and ruxolitinib combination) in myelofibrosis and essential thrombocythemia; axatilimab (Niktimvo) GVHD safety/interim data; multiple poster sessions across INCB programs, tafasitamab in follicular lymphoma, and real‑world ruxolitinib analyses.
Incyte will host an investor webcast on Dec 7, 2025, 11:00 a.m. – 12:30 p.m. ET to discuss the mutCALR oral presentation; replay available for 30 days.
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