Seralutinib advances toward NDA filing as Gossamer Bio cites strong data
Gossamer Bio says positive FDA interactions and robust clinical data support an imminent NDA filing for seralutinib. The company highlights efficacy in key subgroups, a favorable safety profile, and a CTD-associated PAH positioning focus.
Positive FDA interactions and clinical data support an imminent NDA filing for seralutinib, with efficacy in key subgroups and a favorable safety profile. The program is positioned to address unmet needs, especially in CTD-associated PAH, and Gossamer Bio said commercial readiness is high.