Also known as: Incyte
Incyte is a U.S. multinational pharmaceutical company headquartered in Wilmington, Delaware. The company develops and manufactures prescription biopharmaceutical medicines across oncology, inflammation, and autoimmunity.
Incyte has started the phase 3 Dawn-03 trial of INCB161734 plus chemotherapy in first-line KRAS G12D-mutant pancreatic cancer. The move comes while the phase 1 study remains halted in four European countries after pneumonitis cases, including one grade 5 event.
Adagene and Incyte will collaborate on a Phase 1 study combining muzastotug with INCA33890 for MSS colorectal cancer patients, beginning in 2026. The collaboration marks the second instance where Adagene's SAFEbody technology is paired with a PD-1-based bispecific. Muzastotug has shown encouraging response rates in combination with pembrolizumab in previous trials.
The myelofibrosis therapeutic pipeline now includes over 40 candidates from more than 35 companies, with recent developments including Orphan Drug Designation for CK0804 and multiple Phase III trial initiations. Key clinical milestones include completed enrollment in Karyopharm's SENTRY trial and upcoming Phase I data from Incyte's combination therapy studies.
The FDA has approved Bristol Myers Squibb's CAR-T therapy Breyanzi for relapsed/refractory marginal zone lymphoma, while a novel multiple myeloma drug candidate DTP3 advances to Phase 2 trials after showing promising early results. Both developments represent significant progress in blood cancer treatment, with the marginal zone lymphoma approval based on a 95.5% response rate and the myeloma drug demonstrating selective cancer cell killing without toxicity.
DelveInsight pipeline reports reveal robust clinical development across three cancer indications, with 45+ companies advancing cutaneous squamous cell carcinoma therapies, 70+ companies developing liver cancer treatments, and multiple hepatocellular carcinoma candidates receiving FDA designations in 2025-2026.
Syndax Pharmaceuticals announced a collaboration to expand global access to Revuforj while reporting strong commercial performance for its two marketed products, with Revuforj generating $125 million and Niktimvo $152 million in the first 11 months of sales.
Incyte received a Complete Response Letter from the FDA for Zynyz in lung cancer due to third-party manufacturing issues, while the EMA recommended approval for the drug in anal cancer treatment based on Phase 3 trial data.
A comprehensive market report reveals over 180 companies are developing more than 200 PD-1 and PD-L1 inhibitor drugs, with recent fast-track designations and successful Phase III trial results driving expansion in cancer immunotherapy.
Oncolytics Biotech received FDA Fast Track Designation for pelareorep in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer, based on clinical data showing a 33% response rate and median overall survival of 27 months versus 11.2 months with standard treatment.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07588139 |
A Study to Evaluate Dermal Open-Flow Microperfusion and Plasma Pharmacokinetic Study of Multiple Doses of Oral Povorcitinib or Topical Ruxolitinib Cream in Healthy Adult Participants |
RECRUITING | PHASE1 |
| NCT07559474 |
A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment |
NOT_YET_RECRUITING | PHASE1 |
| NCT07559396 |
A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease |
NOT_YET_RECRUITING | PHASE1 |
| NCT07548983 |
Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation |
NOT_YET_RECRUITING | PHASE1 |
| NCT07522073 |
A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma |
RECRUITING | PHASE3 |
| NCT07511062 |
Axatilimab Combined With Decitabine/Venetoclax for the Treatment of TP53-mutated AML |
NOT_YET_RECRUITING | PHASE1 |
| NCT07502872 |
TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07448155 |
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous Administration in Healthy Adult Participants |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT07441694 |
Study of INCA036978 in Participants With Myeloproliferative Neoplasms |
RECRUITING | PHASE1 |
| NCT07434843 |
PH 2 Pemigatinib in SDH-deficient GIST |
RECRUITING | PHASE2 |
