Gossamer确认Seralutinib可按9月NDA路径推进并收回全球权益

Gossamer Bio, Inc. (GOSS) announced that following a productive Pre-NDA Type B meeting with the U.S. FDA and receipt of the official meeting minutes, the company is moving forward with a planned NDA submission for Seralutinib in pulmonary arterial hypertension in September 2026.
If accepted for filing, Seralutinib could be eligible for an FDA approval decision in the third quarter of 2027.
Pulmonary arterial hypertension (PAH) is a rare, progressive disease that causes high blood pressure in the lungs, leading to shortness of breath, fatigue, and heart failure. Current therapies often slow progression but do not fully address the unmet need for patients living with this condition.
Seralutinib is an investigational, inhaled, small-molecule therapy designed to target key pathways involved in PAH and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company believes it has the potential to be a first-in-class treatment option.
Alongside the regulatory update, Gossamer announced it has reacquired worldwide development and commercial rights to Seralutinib from Chiesi, giving the company full global control over the program. Management emphasized that this move secures the majority of long-term economics for shareholders and positions Gossamer to maximize the strategic and financial value of Seralutinib.
The company also reported preliminary cash, cash equivalents, and marketable securities of approximately $57 million as of June 30, 2026. Through the exchange, Gossamer exchanged approximately $181.1 million, or 90.5%, of the $200 million aggregate principal amount of 2027 Notes outstanding for approximately $65.2 million of new 7.50% Convertible Senior Secured First Lien Notes due 2030, together with the applicable equity securities and warrants.
Shareholders approved proposals related to a convertible note exchange and a reverse stock split, strengthening the capital structure ahead of the NDA filing.The company expects to effect the reverse stock split in or promptly following the third quarter of 2026.
"This is a defining moment for Gossamer," said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer, noting that years of disciplined execution have brought the company closer than ever to delivering a new medicine for PAH patients who need better options.
GOSS has traded between $0.11 and $3.87 over the past year. The stock is currently trading at $0.19, up 41.16%.
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