Gossamer Bio regains rights to lung disease asset from Chiesi after Phase 3 failure, eyes FDA submission

Gossamer Bio announced that it has taken back the rights to its inhaled pulmonary hypertension candidate from partner Chiesi after the drug failed to meet its primary endpoint in a Phase 3 trial.

The Phase 3 study of seralutinib in pulmonary arterial hypertension did not show a statistically significant improvement in functional performance, prompting a sharp decline in the company’s share price.

Despite the setback, Gossamer’s leadership said the FDA’s review of the trial data highlighted "review issues" rather than filing deficiencies. The company plans to submit a new drug application in September, aiming for a regulatory decision by next August.

CEO Faheem Hasnain reiterated confidence in the program during an investor call, noting that the recent FDA meeting minutes provide new insight that could support the upcoming submission.