Cogent Biosciences Stock Gains 8% After FDA Accepts NDA For Bezuclastinib, Assigns PDUFA Date

Cogent Biosciences shares jumped ~8% after the FDA accepted its New Drug Application for bezuclastinib in patients with non-advanced systemic mastocytosis, marking a key regulatory milestone. The acceptance increases probability of eventual approval and could meaningfully affect the company's commercial outlook if approved; market participants reacted quickly with a sizable intraday move.

Analysis

Cogent Biosciences shares jumped ~8% after the FDA accepted its New Drug Application for bezuclastinib in patients with non-advanced systemic mastocytosis, marking a key regulatory milestone. The acceptance increases probability of eventual approval and could meaningfully affect the company's commercial outlook if approved; market participants reacted quickly with a sizable intraday move.