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NOV 30 2026
UPCOMING · 122 DAYS TO PDUFA

Cogent Biosciences bezuclastinib $COGT

for imatinib-resistant gastrointestinal stromal tumor (GIST)

NDA · Priority Review · Breakthrough

Accepted MAY 28 2026.

About

Gastrointestinal stromal tumors (GISTs) are the most common connective tissue cancers of the digestive tract, and their growth is typically driven by mutations in a gene called KIT. Bezulcastinib is a pill designed to selectively block the specific, mutated form of the KIT protein that fuels these tumors. By precisely targeting this faulty driver, the drug could potentially stop tumor growth in patients whose cancers have become resistant to other treatments.

Pivotal trial

NCT05208047 Phase 3 recruiting NCT05208047

This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 482 patients

Source: ClinicalTrials.gov

Also in development