GLOBAL RESEARCH ARCHIVE
GOSS: CT FRI Substudy Provides More Support for Seralutinib's Potential Treatment Effect, But Regulatory, Commercial and Financial Questions Remain; 1Q 2026 Earnings Recap
Research evidence excerpt
GOSS: CT FRI Substudy Provides More Support for Seralutinib's Potential Treatment Effect, But Regulatory, Commercial and Financial Questions Remain; 1Q 2026 Earnings Recap
May 18, 2026
Vamil Divan, M.D. vamil.divan@guggenheimpartners.com GOSS: CT FRI Substudy Provides More Support
212 823 6543 for Seralutinib's Potential Treatment Effect, But
Daniel Krizay, Ph.D.
daniel.krizay@guggenheimpartners.com Regulatory, Commercial and Financial Questions
212 823 6561 Remain; 1Q 2026 Earnings Recap Arseniy Shabashvili
arseniy.shabashvili@guggenheimpartners.com
212 699 1971 Key Message: Gossamer reported 1Q 2026 earnings and provided a corporate update
Edouard Mullarky, Ph.D. this morning. In this update, the company released topline data from their PROSERA
edouard.mullarky@guggenheimpartners.com CT functional respiratory imaging (FRI) substudy, announced their convertible notes
212 518 9579 exchange offer, and communicated their updated regulatory plans for seralutinib in
PAH. We believe the data from the CT FRI substudy supports our view that seralutinib
does have a moderate treatment effect in this patient population, with positive structural
changes observed in the pulmonary arteries, veins, and parenchyma. However, we still
question if this supportive data will be compelling enough to move the needle fromGOSS NEUTRAL a regulatory perspective, given the lack of a statistically significant improvement in Gossamer Bio, Inc. important clinical endpoints like six-minute walk distance (6MWD) and time to clinical Sector: Biotechnology
worsening. A Type B pre-NDA meeting has been scheduled with the FDA for mid-June,
Earnings Release with the company anticipating sharing FDA feedback from this meeting with the Street
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