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Gossamer Bio Advances Seralutinib Toward NDA In September 2026, Reacquires Global Rights To Seralutinib From Chiesi

Benzinga·07/27/2026 11:02:58
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– Pre-NDA Type B Meeting and FDA Minutes Provide Path to September 2026 NDA Submission for Seralutinib in PAH –

– Gossamer Reacquires Worldwide Rights to Seralutinib, Aligning Global Commercial Control for a Potential First-in-Class Opportunity –

– Stockholders Approved Proposals Related to Convertible Note Exchange and Reverse Stock Split, Supporting a Strengthened Capital Structure –

– Cash, Cash Equivalents and Marketable Securities Totaled Approximately $57 Million as of June 30, 2026 –

Gossamer Bio, Inc. (NASDAQ:GOSS) (the "Company" or "Gossamer"), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), announced a series of regulatory, strategic, and corporate updates. Following a productive Pre-NDA Type B meeting with the U.S. Food and Drug Administration (FDA) and receipt of the official meeting minutes, the Company is proceeding toward a planned NDA submission for seralutinib for the treatment of patients with PAH in September 2026. In addition, Gossamer has reacquired worldwide development and commercial rights to seralutinib from Chiesi, and Gossamer’s stockholders approved proposals related to the previously announced convertible note exchange and authorized the Company to effect a reverse stock split and related proposals at a special meeting. The Company also reported, on a preliminary basis, that cash, cash equivalents and marketable securities totaled approximately $57 million as of June 30, 2026.