Cogent Submits NDA for Bezuclastinib in GIST Tumors, Eyes NDA for AdvSM in H1 2026
ByAinvest
Thursday, Apr 2, 2026 3:30 am ET1min read
COGT--
Cogent Biosciences has submitted an NDA to the FDA for Bezuclastinib in patients with GIST who have received prior Imatinib treatment. The submission is based on the positive results from the PEAK trial, which demonstrated a 50% reduction in disease progression or death compared to the standard of care. The company also plans to submit an NDA for Bezuclastinib in Advanced Systemic Mastocytosis in H1 2026.
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