Bezuclastinib and Sunitinib for Gastrointestinal Stromal Tumors

Bezuclastinib and Sunitinib for Gastrointestinal Stromal Tumors
100%75%50%25%0%May 21May 22May 23May 24May 25May 21 • YES 40.1%May 22 • YES 41.2%May 23 • YES 42.1%May 24 • YES 29.4%May 25 • YES 29.9%
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COGT

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 3Matched bezuclastinib, sunitinib, gastrointestinal, stromal, plus
COGT

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 CTMatched bezuclastinib, sunitinib, gastrointestinal, stromal
COGT

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

Presentation / Abstract • Phase 3Matched bezuclastinib, sunitinib, gastrointestinal, stromal, plus
COGT

Cogent Biosciences Announces Anticipated 2026 Commercial and Clinical Milestones for Bezuclastinib and Precision Therapies Portfolio

New Drug Application (NDA) for NonAdvSM submitted in December 2025, NDA submission for AdvSM on track for 1H 2026 NDA submission for GIST on track for April 2026; bezuclastinib has the potential to be the first new therapy for second-line GIST in over 20 years Clinical data presentations from all

Trial Design Update • Phase 1/2Matched bezuclastinib, sunitinib, gastrointestinal, stromal
COGT

Cogent Biosciences Highlights Additional Data with Six Bezuclastinib Posters from SUMMIT Trial at 2026 AAAAI Annual Meeting

Bezuclastinib mean TSS reduction deepens to –32.0 points at 48 weeks of treatment with further improvement shown across all measured symptoms 99% of patients achieve >50% reduction in serum tryptase at 48 weeks, with 83% rate of normalization Strong evidence of bezuclastinib’s potential as first

Presentation / AbstractMatched bezuclastinib, gastrointestinal, stromal
COGT

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 CESTMatched bezuclastinib, gastrointestinal, stromal
COGT

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 2Matched bezuclastinib, gastrointestinal, stromal