NEW YORK, December 31, 2025, 11:55 ET — Regular session
- Cogent Biosciences shares fell about 2.5% in late morning trade
- The company said it filed its first U.S. new drug application for bezuclastinib in non-advanced systemic mastocytosis
- SEC filings showed four senior executives sold shares late last week
Shares of Cogent Biosciences slid on Wednesday, paring losses from earlier in the session, after the biotech disclosed a key regulatory filing while investors digested a cluster of insider stock sales. The stock was down 2.5% at $36.19, after touching a low of $34.33.
The move comes as Cogent shifts from late-stage data to the U.S. Food and Drug Administration review process — a step that can widen the audience beyond biotech specialists and pull more short-term traders into the name.
A New Drug Application, or NDA, is the formal package drugmakers submit to the FDA to seek permission to market a medicine in the United States. Acceptance of the filing and the agency’s review timeline are typically the next near-term markers investors trade around.
Cogent said on Tuesday it submitted an NDA for bezuclastinib in non-advanced systemic mastocytosis, a rare disease driven in most patients by mutations in the KIT gene. “This NDA is the first of three planned submissions for bezuclastinib,” President and Chief Executive Officer Andrew Robbins said. GlobeNewswire
The company said the filing was supported by data from its SUMMIT pivotal trial and followed FDA Breakthrough Therapy designation — an expedited-development label the agency can grant to drugs aimed at serious conditions with potential to offer substantial improvement. BioSpace
Still, filings showed multiple executives sold shares in transactions dated Dec. 26 and signed on Dec. 30. Chief Financial Officer John L. Green sold 77,000 shares at an average price of $38.68, Chief Medical Officer Jessica Sachs sold 82,642 shares at about $38.70, Chief Scientific Officer John Edward Robinson sold 90,000 shares at $38.74, and Chief Legal Officer Evan Kearns sold 65,000 shares at about $38.70, the filings showed. SEC
Cogent’s pullback has come after a sharp rally earlier this year, leaving the stock within a wide 52-week range of $3.72 to $43.73, according to Nasdaq data. Nasdaq
Bezuclastinib is a targeted therapy known as a tyrosine kinase inhibitor — a type of drug that blocks enzymes that can drive abnormal cell growth — designed to inhibit KIT D816V and other KIT mutations linked to systemic mastocytosis, a recent quarterly filing described. SEC
Cogent is pushing into a field where Blueprint Medicines’ Ayvakit (avapritinib) is already approved for advanced and indolent systemic mastocytosis in the United States, according to the drug’s FDA label. FDA Access Data
Beyond the non-advanced systemic mastocytosis submission, Cogent said NDA filings for bezuclastinib in gastrointestinal stromal tumors (GIST) and advanced systemic mastocytosis remain on track for the first half of 2026. Businessinsider
For traders, the next immediate catalysts are procedural: whether the FDA accepts the NDA for review and what review clock it assigns. Any commentary around the agency’s questions, or the timing of the company’s next two planned submissions, is likely to set the tone into early 2026.
