Cogent: Itinakda ng FDA ang PDUFA sa Disyembre 30, 2026 para sa NonAdvSM NDA ng bezuclastinib

FDA accepted the bezuclastinib NDA for NonAdvanced Systemic Mastocytosis and assigned a PDUFA target action date of December 30, 2026. The filing was submitted under the Real-Time Oncology Review program. A separate NDA for GIST was also submitted under RTOR, with a third NDA for AdvSM planned for H1 2026.

Mahahalagang fact

Na-file: May 5, 2026, 12:08 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: COGTCogent
Asset: bezuclastinib
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Nob 30, 2026

Sipi mula sa source

EX-99.1 2 cogt-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Cogent Biosciences Reports Recent Business Highlights and First Quarter 2026 Financial Results - Planning for dual launches of bezuclastinib in Systemic Mastocytosis and Gastrointestinal Stromal Tumors (GIST) - Pivotal data from Phase 3 PEAK trial in GIST patients selected for oral presentation at 2026 ASCO annual meeting - Ended 1Q 2026 with $866.4 million in cash, sufficient to fund operations into 2028 WALTHAM, Mass. and BOULDER, Colo., May 5, 2026 – Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2026. “2026 is shaping up to be a p

SEC 8-K