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The team is preparing an NDA for seralutinib following positive FDA feedback and strong phase III and subgroup data, especially in CTD-associated PAH. Broad label approval is anticipated, with rapid commercial uptake expected due to favorable safety and efficacy, and future pipeline expansion plann…
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.