FDA Grants Priority Review to Cogent's GIST Drug Bezuclastinib NDA, Sets November PDUFA Date
Summary
The FDA has accepted Cogent Biosciences' New Drug Application for bezuclastinib in combination with sunitinib for GIST patients, granting it Priority Review. This follows the NDA submission announced on April 1st and builds on the drug's prior Breakthrough Therapy Designation. The PDUFA target action date is set for November 30, 2026, with no advisory committee meeting currently planned. This is a major de-risking event for a lead pipeline candidate, as the Phase 3 PEAK trial demonstrated a statistically significant 50% reduction in disease progression or death. Full results from the PEAK trial are scheduled for an oral presentation at ASCO on May 30, 2026.
At the time of this announcement, COGT was trading at $34.91 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $5.9B. The 52-week trading range was $4.80 to $43.73. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.