NEW YORK, December 30, 2025, 14:40 ET — Regular session
Shares of Cogent Biosciences, Inc. fell 2.7% to $36.88 on Tuesday after the biotech said it submitted a New Drug Application to the U.S. Food and Drug Administration for its drug candidate bezuclastinib in nonadvanced systemic mastocytosis. Yahoo Finance
An NDA is the formal request asking the FDA to review a drug for marketing approval, a key inflection point for development-stage biotechs with no products on the market. U.S. Food and Drug Administration
Systemic mastocytosis is a rare disorder marked by abnormal accumulation and activation of mast cells — immune cells that can trigger wide-ranging, allergic-type symptoms and complications across organs. National Organization for Rare Disorders
“This NDA is the first of three planned submissions for bezuclastinib,” President and Chief Executive Officer Andrew Robbins said. Cogent said the filing is based on positive data from its SUMMIT trial and follows an FDA Breakthrough Therapy Designation granted in October, a status intended to speed development of treatments for serious conditions when early evidence suggests a substantial improvement. The company said it plans two additional bezuclastinib NDA submissions in the first half of 2026 for gastrointestinal stromal tumors, a type of cancer, and advanced systemic mastocytosis. GlobeNewswire
Cogent says bezuclastinib is a tyrosine kinase inhibitor — a targeted drug that blocks growth-signaling enzymes — designed to inhibit the KIT D816V mutation and related KIT exon 17 mutations implicated in the disease. Cogent Biosciences
Under federal regulations, the FDA generally decides within 60 days of receiving an NDA whether it is sufficiently complete to file for substantive review. eCFR
FDA performance goals under the Prescription Drug User Fee Act call for action on most standard new drug applications within 10 months of the 60-day filing date, and within six months for priority reviews. U.S. Food and Drug Administration
The biotech group also leaned lower on Tuesday, with the SPDR S&P Biotech ETF down about 1.5% and the iShares Nasdaq Biotechnology ETF off about 1.2%.
Cogent is seeking to expand options in a market where avapritinib, marketed as Ayvakit, is already approved in the United States for adults with indolent systemic mastocytosis. FDA Access Data
Raymond James reiterated its Strong Buy rating on Cogent and kept a $60 price target following the NDA submission, according to Investing.com. Investing
