Seralutinib Update: U.S. Approval Filing Planned
- Robyn Kalda
- 4 days ago
- 1 min read
Back in March, we noted that Gossamer Bio’s phase 3 clinical trial of seralutinib (a drug for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease) didn’t meet its primary endpoint, causing a steep drop in its stock price. The study had some promising results: it showed a potentially good response to seralutinib, but some locations had an unusually good response to the placebo, which may have affected the analysis. Despite the study's technical failure, Gossamer Bio said it would explore a path forward for seralutinib in the U.S.
Subsequent months involved corporate machinations and meetings with the U.S. Food and Drug Agency.
On July 27, Gossamer Bio announced it had acquired the rights to develop seralutinib from its partner and planned to submit a New Drug Application (NDA) in the U.S. for seralutinib in September 2026. The FDA could approve seralutinib as early as the 3rd quarter of 2027.
At this point, they have not mentioned any plans to submit seralutinib for approval in Canada.
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