Gossamer Bio Submits First NDA to FDA for Seralutinib in PAH
GOSS sits 21% above its 52-week low of $9.104.
Summary
Gossamer Bio has submitted its first New Drug Application to the FDA for seralutinib in pulmonary arterial hypertension. The submission is supported by the Phase 3 PROSERA study, with confirmatory evidence from Phase 2 TORREY. FDA meeting minutes from June characterized the PROSERA efficacy findings as review issues rather than filing issues, which reduces near-term rejection risk. The company expects an FDA filing decision later this year. This is a major regulatory milestone for a company with a going concern warning and cash runway only into Q1 2027; approval would transform its outlook. Watch for the FDA's acceptance decision, expected in the coming months.
At the time of this announcement, GOSS was trading at $11.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $67.2M. The 52-week trading range was $9.10 to $309.60. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.