Cogent Biosciences (COGT) stock jumps as FDA filing timeline sharpens — what investors watch next

Cogent Biosciences shares rose about 8% on Wednesday, lifting the biotech’s stock toward recent highs as investors focused on a near-term U.S. regulatory checkpoint for its lead drug candidate, bezuclastinib. The stock was up at $38.17, after trading between $35.17 and $38.34.

Cogent Biosciences (COGT) soars ~115% after PEAK Phase 3 shows 16.5‑month PFS in GIST; NDA targeted for 1H 2026 (Nov. 10, 2025)

Cogent Biosciences (COGT) soars ~115% after PEAK Phase 3 shows 16.5‑month PFS in GIST; NDA targeted for 1H 2026 (Nov. 10, 2025)

Cogent Biosciences announced positive top‑line results from its Phase 3 PEAK trial testing bezuclastinib plus sunitinib in second‑line gastrointestinal stromal tumor, sending the stock sharply higher in Monday trading. The combination delivered a median progression‑free survival of 16.5 months vs. 9.2 months for sunitinib alone and a 46% objective response rate vs. 26% on sunitinib monotherapy. GlobeNewswire