NasdaqGS:COGTBiotechs
Is Bezuclastinib’s FDA Filing And Disease-Modifying Data Altering The Investment Case For Cogent Biosciences (COGT)?
Cogent Biosciences recently submitted a New Drug Application to the FDA for bezuclastinib in advanced systemic mastocytosis, supported by positive pivotal APEX trial data across multiple disease subtypes and response criteria.
An interesting aspect of the filing is the extensive evidence of disease modification, including normalization of bone marrow characteristics and undetectable KIT D816V levels in a meaningful subset of patients, alongside active Expanded Access Programs for those with...