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Cogent Biosciences, Inc.

Pipeline5 assets

  • bezuclastinibCGT9486 / KIT exon 17/KIT D816V / small molecule tyrosine kinase inhibitor / Oncology; hematology
    NonAdvanced Systemic MastocytosisNDA acceptedFDA review; PDUFA December 30, 2026USGastrointestinal Stromal Tumors after prior imatinibNDA submittedFDA reviewUSAdvanced Systemic Mastocytosisregistration-directed trial completedNDA planned 1H 2026US
  • CGT4255CGT4255 / mutant ErbB2/HER2 / CNS-penetrant small molecule inhibitor / Oncology
    Advanced solid tumors with HER2 mutations or HER2 overexpressionPhase 1dose escalation ongoing
  • CGT6297CGT6297 / PI3Kα / small molecule inhibitor / Oncology
    PI3Kα-mutant cancersPhase 1initiated
  • CGT1815CGT1815 / pan-KRAS(ON) / small molecule inhibitor / Oncology
  • CGT1145CGT1145 / JAK2 V617F / small molecule inhibitor / Hematology

Latest news15 items

All news

Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST

NDA acceptance with Priority Review builds upon previous assignment of Breakthrough Therapy Designation and Real-Time Oncology Review following Phase 3 PEAK results; PDUFA date set for November 30, 2026 Bezuclastinib combination is first treatment ever to demonstrate statistically significant

Presentation / Abstract • Phase 3ASCO oral presentation Sat, May 30, 2026, 3:00 PM CT

Cogent Biosciences Announces Multiple Presentations at the European Hematology Association (EHA) 2026 Congress

Pivotal data from APEX trial in Advanced Systemic Mastocytosis accepted for oral presentation; Cogent’s third oral presentation of pivotal data with bezuclastinib at major medical meetings Preclinical data from selective, potent JAK2 V617F program accepted for poster presentation WALTHAM, Mass.

Presentation / Abstract • Phase 3Oral presentation Sat, Jun 13, 2026, 5:15 PM CEST

Cogent Biosciences Announces Oral Presentation of Positive Phase 3 PEAK Trial in Gastrointestinal Stromal Tumors (GIST) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

WALTHAM, Mass. and BOULDER, Colo., April 21, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the results from the Phase 3 PEAK trial have been selected for

Presentation / Abstract • Phase 3

Cogent Biosciences Announces Multiple SUMMIT Posters at the 2026 AAAAI Annual Meeting

WALTHAM, Mass. and BOULDER, Colo., Feb. 10, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced multiple upcoming posters highlighting bezuclastinib results from the

Presentation / Abstract • Phase 2
Cogent Biosciences, Inc. • Endpoint Arena