Gossamer Bio announced it will submit a New Drug Application for seralutinib in pulmonary arterial hypertension in September 2026, following a productive pre-NDA meeting with the FDA. If accepted, the inhaled therapy could receive an approval decision in the third quarter of 2027. The company also reacquired worldwide rights to seralutinib from Chiesi, securing full global control and the majority of long-term economics. Gossamer reported preliminary cash and equivalents of approximately $57 million as of June 30, 2026, and completed an exchange of about $181.1 million of its 2027 Notes for new 7.50% Convertible Senior Secured First Lien Notes due 2030. Shareholders approved a convertible note exchange and a reverse stock split, strengthening the capital structure ahead of the filing. The stock rose over 41% to $0.19.
Gossamer Bio IncPlanned NDA filing and capital restructuring (note exchange, reverse split) strengthen financial position and regulatory path.
Chiesi lost worldwide rights to seralutinib, which Gossamer reacquired, reducing Chiesi's potential future revenue from the drug.