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COGT · Cogent Biosciences, Inc. · Investor Relations

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Volume · Oct 21 204.68K Avg daily vol (3M) 1.98M

Press releases and events scraped from the company’s investor relations website. Past events open our own call or event page when we host one; otherwise listings link to the original source.

Recent news

Date Headline
2026-09-15 Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

NDA supported by positive results from the APEX pivotal trial demonstrating clinically meaningful responses and evidence of disease modification in patients with AdvSM PDUFA target action date set for June 29, 2027 WALTHAM, Mass. and BOULDER, Colo., Sept.

2026-08-10 Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2026 Financial Results

On track for potential approval of bezuclastinib for GIST patients (PDUFA November 30) and NonAdvSM patients (PDUFA December 30) later this year; AdvSM New Drug Application submitted to FDA on June 30 Completed onboarding of expert cross-functional Cogent customer-facing team, including all

2026-06-30 Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM)

Submission based on results of APEX pivotal trial which demonstrated bezuclastinib objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria with a well-tolerated safety profile for AdvSM patients APEX NDA is third submission for bezuclastinib in six months; PEAK

2026-06-12 Cogent Biosciences Announces Preclinical Data from Novel JAK2 V617F Inhibitor at the 2026 European Hematology Association (EHA) Congress

- JAK2 V671F poster presentation showcases potential best-in-class properties, including improved selectivity compared with currently approved JAK inhibitors - - Selective JAK V617F inhibitor, CGT1145, on track for IND in 2026 - WALTHAM, Mass. and BOULDER, Colo., June 12, 2026 (GLOBE NEWSWIRE) --

2026-06-12 Cogent Biosciences Announces Detailed Data from APEX Pivotal Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis at the 2026 European Hematology Association (EHA) Congress

-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an updated objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria – -- Bezuclastinib demonstrated a powerful effect on mast cell burden with 91% of patients achieving

2026-05-30 Cogent Biosciences Announces Detailed Clinical Data from PEAK Phase 3 Trial with Bezuclastinib in Combination with Sunitinib in Gastrointestinal Stromal Tumors (GIST) at 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

Bezuclastinib combination is first treatment ever to demonstrate statistically significant advantage against active comparator in GIST patients; median PFS of 16.5 months versus 9.2 months (HR=0.50, CI: 0.39-0.65, p

2026-05-28 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

2026-05-27 Cogent Biosciences Announces Participation in the 2026 Jefferies Global Healthcare Conference

WALTHAM, Mass. and BOULDER, Colo., May 27, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced its participation in the Jefferies Global Healthcare Conference in New

2026-05-12 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.

2026-05-05 Cogent Biosciences Reports Recent Business Highlights and First Quarter 2026 Financial Results

- Planning for dual launches of bezuclastinib in Systemic Mastocytosis and Gastrointestinal Stromal Tumors (GIST) - Pivotal data from Phase 3 PEAK trial in GIST patients selected for oral presentation at 2026 ASCO annual meeting - Ended 1Q 2026 with $866.4 million in cash, sufficient to fund

Past events

Date Event Type
2026-06-03 Jefferies Healthcare Conference Conference
2026-06-03 Jefferies Global Healthcare Conference in New York Conference
2026-06-03 Jefferies Global Healthcare Conference Conference
2025-12-08 SM Update December 2025 Webcast
2025-11-10 Top-Line Results from PEAK Trial in GIST Patients Earnings call
2025-07-07 Top-Line Results from SUMMIT Trial in NonAdvanced SM Patients Event

Source: https://investors.cogentbio.com/

Key facts CIK 1622229 CUSIP 19240Q201 13F (30d) 20 filings 20 filers Visit website Investor relations