Welcome to our dedicated page for Incyte news (Ticker: INCY), a resource for investors and traders seeking the latest updates and insights on Incyte stock.
News for Incyte Genomics Inc (Nasdaq: INCY), operating as Incyte Corporation, centers on its activities as a global biopharmaceutical company focused on Oncology and Inflammation & Autoimmunity. Company releases describe a portfolio of first‑in‑class medicines and a pipeline of proprietary therapeutics, making INCY news particularly relevant for investors and healthcare observers following cancer and immune‑related drug development.
Recent headlines highlight late-stage clinical trial results and regulatory milestones. Incyte has reported positive topline data from the Phase 3 frontMIND trial of tafasitamab (Monjuvi/Minjuvi) plus lenalidomide and R‑CHOP as first‑line therapy for diffuse large B‑cell lymphoma, meeting primary and key secondary endpoints. Other news covers European Commission and Japanese approvals of Minjuvi in combination regimens for relapsed or refractory follicular lymphoma and DLBCL, underscoring the company’s role in B‑cell lymphoma treatment.
In immuno‑oncology, Incyte Biosciences Japan G.K. has announced approval of Zynyz (retifanlimab) with platinum‑based chemotherapy as first‑line treatment for advanced squamous cell carcinoma of the anal canal, following earlier U.S. approval in a similar setting. Additional coverage describes submissions to European regulators and the broader POD1UM clinical program evaluating retifanlimab across solid tumors.
News flow also features pipeline updates for INCA033989, a first‑in‑class mutCALR‑targeted monoclonal antibody for myeloproliferative neoplasms. Incyte has disclosed Breakthrough Therapy designation from the U.S. FDA for essential thrombocythemia with Type 1 CALR mutations, along with Phase 1 data in ET and myelofibrosis showing hematologic responses, spleen volume reductions, symptom improvements and safety findings.
Beyond R&D, Incyte issues releases on leadership changes, board transitions, inducement equity grants and participation in major healthcare investor conferences. For investors and analysts, the INCY news page provides a centralized view of clinical, regulatory, corporate governance and capital markets developments affecting the company.
Incyte (NASDAQ:INCY) announced European Commission approval of Minjuvi (tafasitamab) in combination with lenalidomide and rituximab for adult patients with relapsed or refractory follicular lymphoma (Grade 1-3a) after ≥1 systemic therapy.
The approval follows a positive CHMP opinion and is supported by Phase 3 inMIND results: investigator-assessed median progression-free survival (PFS) 22.4 months versus 13.9 months (HR 0.43; P<0.0001); IRC-assessed PFS not reached versus 16.0 months (HR 0.41). Safety was described as generally well-tolerated; common adverse reactions (≥20%) included respiratory infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain and cough.
Incyte (Nasdaq: INCY) announced that Hervé Hoppenot has resigned from the company's Board of Directors, effective immediately on December 12, 2025.
Mr. Hoppenot had been serving as an advisor to the CEO and as a board member during a planned transition period. He joined Incyte in 2014 and previously served as chairman and CEO. Julian Baker, Incyte's chairman, thanked Mr. Hoppenot for his leadership and said he left a lasting impact on the company’s work delivering transformative science and medicines for patients.
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.