Incyte Corp. is a biopharmaceutical company, which engages in the discovery, development, and commercialization of proprietary therapeutics. It focuses on hematology and oncology, and inflammation and autoimmunity therapeutic areas. The company was founded in April 1991 and is headquartered in Wilmington, DE.
Clinical Trials
635
353 active
Approvals
15
Total approvals
Agencies
2
Regulatory bodies
Founded
N/A
Active, not recruiting
343
54.0%
Approved For Marketing
3
0.5%
Available
2
0.3%
Completed
151
23.8%
No Longer Available
5
0.8%
Not yet recruiting
10
1.6%
Recruiting
42
6.6%
Terminated
66
10.4%
Withdrawn
13
2.0%
- Ryvu Therapeutics SA has terminated its Phase 2 POTAMI-61 study of RVU120 in intermediate- or high-risk primary or secondary myelofibrosis. - The open-label trial tested oral RVU120 as monotherapy and combined with the JAK inhibitor ruxolitinib, with no placebo arm and non-random allocation. - The study record, first submitted 2024-04-29 and last updated 2026-09-15, is now listed as terminated before planned completion, pressuring the blood cancer pipeline.
- China's NMPA approved Lumirix® (ruxolitinib phosphate cream) on 2 September 2026 for mild-to-moderate atopic dermatitis in non-immunocompromised adults and pediatric patients aged 2 years and older. - In a Phase III trial, Lumirix® met its primary endpoint with 63.0% of patients achieving IGA 0/1 versus 9.2% for placebo (P < 0.001), and EASI 75 in 78.0% versus 15.4% (P < 0.001). - The approval expands Lumirix® beyond its January 2026 vitiligo indication, making it the first topical JAK inhibitor approved in China for vitiligo. - The indication addresses a large unmet need, with over 54 million AD patients in China as of 2024, of whom mild-to-moderate cases represent over 52.5 million.
- Knight Therapeutics submitted a supplemental application to ANVISA seeking approval for MINJUVI (tafasitamab) plus lenalidomide added to R-CHOP as first-line treatment for previously untreated DLBCL and HGBL. - The supplemental application was selected for review under Project Orbis, reflecting a coordinated regulatory pathway across participating agencies. - The submission builds on results from the Phase 3 frontMIND trial, which enrolled 899 adults and evaluated tafasitamab plus lenalidomide added to R-CHOP versus R-CHOP alone. - The filing addresses a significant unmet need, as roughly 40% of DLBCL patients do not respond to initial therapy or relapse thereafter.
- A Nature correspondence argues that pre-clinical data interpretation must be grounded in clinical context to avoid misleading translational conclusions. - The exchange involves researchers from The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust, and The University of Chicago. - The reply clarifies that the Matters Arising discussion concerns the broader clinical implications of findings rather than mechanistic aspects. - Authors disclose extensive industry relationships, including consulting, funding, and patent interests relevant to radiation oncology and cancer research.
- Minjuvi (tafasitamab) combined with rituximab and lenalidomide becomes the first chemotherapy-free CD19/CD20 dual-targeted immunotherapy listed on Australia's PBS for relapsed or refractory follicular lymphoma. - The pivotal Phase 3 inMIND trial demonstrated a 57% reduction in risk of disease progression, relapse, or death, with median PFS of 22.4 months versus 13.9 months in the control arm (HR: 0.43; P<0.0001). - This marks the first new therapy reimbursed on the PBS for relapsed or refractory follicular lymphoma in nine years, effective 1 August 2026. - Follicular lymphoma affects over 10,000 Australians, with approximately 1,500 new diagnoses annually, representing the second most common form of non-Hodgkin lymphoma.
- The AI Protein Design Market was valued at USD 1.58 billion in 2025 and is projected to reach USD 13.70 billion by 2035, growing at a 24.1% CAGR. - Drug Discovery & Therapeutics dominated applications with a 59.30% share in 2025, while De Novo Protein Generation is the fastest-growing technology segment at a 30.60% CAGR. - Isomorphic Labs closed a USD 2.1 billion Series B round, and Chai Discovery signed a licensing agreement with Pfizer for its de novo antibody design model Chai-3. - North America led the market with a 39.60% regional share in 2025, while Asia Pacific is expected to grow fastest at a 28.30% CAGR.
- The CHMP has issued a positive opinion recommending EU approval of Acadia's Daybue (trofinetide) for Rett syndrome following a successful re-examination after an initial rejection in February. - If approved by the European Commission, Daybue would become the first therapy specifically authorized in the EU for the neurobehavioral symptoms of Rett syndrome. - Acadia's Q1 2025 Daybue revenue reached $101 million, representing 20% year-over-year growth, and the company's 2028 sales guidance of $700 million includes European revenue. - The FDA first approved Daybue for Rett syndrome in pediatric and adult patients in 2023, and the drug faces little to no real competition in this indication.
- Incyte has agreed to acquire Vega Therapeutics, a Star Therapeutics subsidiary, for $1.25 billion upfront with up to $750 million in sales milestone payments. - The deal centers on VGA039, a first-in-class, Phase 3 monoclonal antibody targeting Protein S for von Willebrand disease, the most common inherited bleeding disorder. - VGA039 has the potential to be the first subcutaneous prophylactic therapy with once-monthly dosing, replacing current intravenous infusions required two to three times weekly. - The acquisition marks Incyte's first under CEO Bill Meury and aims to diversify the company's portfolio ahead of Jakafi's patent expiration in 2028.
- Exelixis surged 5.0% to $50.99 on Wednesday amid a broad biotechnology rally, with no company-specific catalysts driving the move. - PTC Therapeutics jumped 5.1% to $89.80 on Tuesday, riding the same sector-wide momentum alongside peers posting gains of 4.0% to 6.9%. - Coordinated buying across multiple biotech names suggests institutional investors are rotating into the sector, reflecting improved risk appetite toward growth-oriented healthcare. - Trading volumes remained moderate, with Exelixis at 1.1M shares and PTC Therapeutics at 823,046 shares, indicating measured rather than explosive positioning.
- The frontMIND phase 3 trial demonstrated that adding tafasitamab and lenalidomide to standard R-CHOP therapy reduced progression or death risk by 25% in patients with high-risk diffuse large B-cell lymphoma or high-grade B-cell lymphoma. - This represents only the second randomized phase 3 trial in 25 years to show improved primary efficacy outcomes compared to R-CHOP alone for newly diagnosed DLBCL patients. - The combination achieved 67.3% three-year progression-free survival versus 60.7% with R-CHOP alone, with benefits observed across all patient subgroups including molecular subtypes. - The regimen showed manageable toxicity profiles and maintained high R-CHOP dose delivery, positioning it as a potential new standard of care for high-risk aggressive B-cell lymphomas.
