Cogent Biosciences Submits NDA for Bezuclastinib in Advanced Systemic Mastocytosis, Citing Strong APEX Trial Data
COGT has more than doubled off its 52-week low of $7.07.
Summary
Cogent Biosciences announced the submission of a New Drug Application (NDA) for bezuclastinib in Advanced Systemic Mastocytosis (AdvSM). This submission is based on positive results from the APEX pivotal trial, which demonstrated a 65% objective response rate and an 81% ORR per PPR criteria, alongside a well-tolerated safety profile. This marks the third NDA submission for bezuclastinib in six months, following the FDA's acceptance of an NDA for GIST in late May. The move significantly advances bezuclastinib towards market approval for another key indication, expanding its commercial potential. The company anticipates approvals for other bezuclastinib indications in Q4 2026.
At the time of this announcement, COGT was trading at $38.60 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $6.6B. The 52-week trading range was $7.07 to $43.73. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.