NasdaqGS:COGTBiotechs
Cogent Biosciences (COGT) Is Up 5.5% After FDA NDA Filing For Bezuclastinib In GIST - Has The Bull Case Changed?
Cogent Biosciences has completed its New Drug Application submission to the FDA for bezuclastinib in previously treated GIST, leveraging positive Phase 3 PEAK trial results and Breakthrough Therapy Designation under the Real-Time Oncology Review program.
The PEAK data showed the bezuclastinib plus sunitinib regimen cut the risk of disease progression or death by half versus sunitinib alone, while maintaining a generally manageable safety profile and supporting expanded access programs for...