NasdaqGS:COGTBiotechs
Is FDA Breakthrough Status And Rapid Review For Bezuclastinib Reshaping The Case For Cogent Biosciences (COGT)?
In January 2026, Cogent Biosciences announced that the FDA granted Breakthrough Therapy Designation to bezuclastinib plus sunitinib for previously imatinib-treated GIST, based on PEAK trial data showing improved progression-free survival and a favorable safety profile compared with sunitinib alone.
The FDA’s decision to review Cogent’s New Drug Application under its Real-Time Oncology Review program highlights regulatory interest in potentially accelerating access to this combination...