Gossamer Bio (GOSS) said it plans to submit a New Drug Application for seralutinib in pulmonary arterial hypertension in September 2026 after a Pre-NDA Type B meeting with the FDA and receipt of official meeting minutes.
The company also said it reacquired worldwide development and commercial rights to seralutinib from Chiesi, reported approximately $57 million in cash, cash equivalents and marketable securities as of June 30, 2026, and received stockholder approvals tied to a convertible note exchange and reverse stock split authorization.
- Gossamer plans to submit the seralutinib NDA for PAH in September 2026.
- If accepted for filing, seralutinib could be eligible for an FDA approval decision in the third quarter of 2027.
- Gossamer and Chiesi agreed to terminate their collaboration and license agreement, returning worldwide rights to Gossamer.
- Chiesi will make a one-time $5 million payment to Gossamer under the termination agreement.
- The company exchanged approximately $181.1 million of 2027 notes for approximately $65.2 million of new 2030 notes, related equity securities and warrants.
- Gossamer said the exchange reduced aggregate debt principal by approximately $115.9 million.
- The company expects to effect the reverse stock split in or promptly following the third quarter of 2026, subject to final board action.
