Loading…
Loading…
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
Cogent Biosciences is positioned to build a niche KIT-mutant franchise, leveraging bezuclastinib across three pivotal indications with strong clinical data. COGT holds $866.4 million in cash, supporting operations through 2028 and enabling launches in systemic mastocytosis and GIST, mitigating near-term financing risk. Bezuclastinib has demonstrated robust efficacy in nonadvanced and advanced systemic mastocytosis and second-line GIST, with three regulatory filings and positive pivotal trial results.
- JAK2 V671F poster presentation showcases potential best-in-class properties, including improved selectivity compared with currently approved JAK inhibitors -
-- 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 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.
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
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
WALTHAM, Mass. and BOULDER, Colo.
Full call transcripts — prepared remarks + analyst Q&A — with speaker-by-speaker formatting and one-click switching across every quarter on file.
Click below to see what's inside, then upgrade to read every transcript for COGT and 80,000+ other tickers.
Transcripts source: company-published earnings calls. Speaker attribution and formatting are processed in-app.