Cogent Biosciences (COGT) announced the FDA has accepted its New Drug Application for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors who have received prior treatment with imatinib. The FDA has granted the application Priority Review and assigned a PDUFA target action date of November 30, 2026. Also, the FDA communicated that at this time, there is no plan to hold an advisory committee, nor have they identified any potential review issues.
Andrew Robbins, President and CEO of Cogent Biosciences, said:: "We look forward to presenting the full, groundbreaking results from the PEAK trial at ASCO this weekend, and our preparations for expected bezuclastinib launches in both GIST and systemic mastocytosis later this year are well underway."
In pre-market trading on NasdaqGS, Cogent Biosciences shares are up 2.75 percent to $35.46.
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May 22, 2026 14:46 ET Minutes of the latest Fed policy session was the highlight of the week along with survey data on the U.S. housing market. In Europe, survey data signaled the trends in the euro area private sector. Further, consumer price inflation data from the U.K. was in focus. In Asia, various economic indicators from China drew attention to the health of the economy.