Gossamer Bio to submit NDA for seralutinib in PAH in Sep 2026; reacquires worldwide rights from Chiesi

Gossamer Bio, Inc.

FDA Pre-NDA meeting minutes allow NDA submission based on Phase 3 PROSERA plus confirmatory evidence; submission planned for September 2026.
Gossamer reacquired worldwide rights to seralutinib from Chiesi; Chiesi pays $5M to Gossamer, no upfront cash from Gossamer; Gossamer retains majority of global economics.
Preliminary cash, cash equivalents and marketable securities ~$57M as of June 30, 2026.
Stockholders approved convertible note exchange (reduced debt by ~$115.9M) and authorized reverse stock split to support Nasdaq compliance.
If NDA accepted, FDA approval decision possible in Q3 2027.

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