NasdaqGS:COGTBiotechs
Does Cogent Biosciences (COGT) Bezuclastinib NDA Redefine Its Competitive Position in Mastocytosis Treatment?
Cogent Biosciences previously submitted a New Drug Application to the FDA for bezuclastinib in NonAdvanced Systemic Mastocytosis, supported by statistically significant SUMMIT trial data and Breakthrough Therapy Designation.
The SUMMIT results also marked the first time reductions in serum tryptase were clearly linked with symptom improvement in NonAdvSM, highlighting a potentially meaningful advance for this underserved patient group.
We will now examine how the NDA filing, underpinned by...