FDA Accepts Cogent's Bezuclastinib NDA for Advanced Systemic Mastocytosis, Sets June 2027 Decision Date
COGT has more than doubled off its 52-week low of $11.6.
Summary
The FDA accepted Cogent's NDA for bezuclastinib in Advanced Systemic Mastocytosis and set a PDUFA target action date of June 29, 2027. The agency indicated no advisory committee is planned and no review issues have been identified, reducing regulatory risk. This follows the NDA submission announced in June and adds to the two other NDAs under review with PDUFA dates in late 2026. The APEX trial data showed a 65% overall response rate and 81% pure pathological response, supporting approval prospects. With a market cap near $5.8 billion, this milestone de-risks the lead program and positions the company for potential commercial launches across three indications.
At the time of this announcement, COGT was trading at $33.50 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $5.8B. The 52-week trading range was $11.60 to $43.73. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.