Gossamer Bio Inc. (NASDAQ:GOSS) shares surged 25% on Monday after the biotechnology company provided a positive regulatory update on its lead drug candidate, seralutinib, and announced it had regained full global rights to the therapy.
The clinical-stage drug developer said it recently completed a Pre-NDA Type B meeting with the U.S. Food and Drug Administration, receiving formal meeting minutes that support a planned New Drug Application (NDA) submission for seralutinib in pulmonary arterial hypertension (PAH) this September.
FDA feedback supports planned NDA filing
According to Gossamer Bio, the FDA indicated that questions surrounding the statistical significance and treatment effect observed in the Phase 3 PROSERA trial would be considered review issues rather than obstacles to accepting the application for filing.
The company intends to submit its NDA in September. If the application is accepted, a regulatory decision from the FDA could be expected during the third quarter of 2027.
Company regains worldwide rights to seralutinib
Gossamer Bio also announced it has reacquired the worldwide development and commercialization rights to seralutinib from Chiesi after the companies agreed to terminate their collaboration and licensing agreement.
The termination ends the previous 50/50 U.S. profit-sharing arrangement and restores international rights to Gossamer Bio without requiring an upfront payment from the company.
Under the agreement, Chiesi will make a one-time payment of $5 million to Gossamer Bio. In return, Chiesi will remain eligible to receive capped royalties on future global net sales of seralutinib, along with payments tied to specified regulatory and commercial milestones.
Debt reduced as shareholders approve restructuring measures
Earlier this month, shareholders approved proposals linked to the company’s previously completed exchange of its 5.00% Convertible Senior Notes due 2027 and authorized the board to implement a reverse stock split if required.
The debt exchange reduced Gossamer Bio’s outstanding principal debt by approximately $115.9 million, strengthening its balance sheet.
As of June 30, the company reported approximately $57 million in cash, cash equivalents and marketable securities to support its ongoing operations and regulatory plans.
Gossamer Bio stock price
