Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST)
Cogent Biosciences has completed the submission of a New Drug Application (NDA) to the FDA for bezuclastinib in treatment-resistant Gastrointestinal Stromal Tumors (GIST) patients, based on strong Phase 3 PEAK trial results. The application was submitted under the FDA's expedited Real-Time Oncology Review program. The PEAK trial demonstrated signif…