Gossamer Bio (GOSS) Targets September FDA Submission For Lead Drug Seralutinib

Melissa Masters Tue, July 28, 2026 at 2:04 PM UTC

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Gossamer Bio

Clinical-stage biopharmaceutical company Gossamer Bio, Inc. (Nasdaq: GOSS) announced Monday a series of regulatory, strategic, and corporate milestones, including plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its flagship drug candidate, seralutinib, in September 2026.

The upcoming submission follows a Pre-NDA Type B meeting held with the FDA in mid-June and the receipt of official meeting minutes. According to Gossamer, the FDA characterized the degree of statistical significance and treatment effect observed in its Phase 3 PROSERA study as review issues rather than filing issues.

On this basis, the company intends to submit the application using the Phase 3 PROSERA trial supported by confirmatory evidence from its Phase 2 TORREY trial and related analyses.

If the FDA accepts the submission for filing, seralutinib—an inhaled inhibitor targeting PDGFR, CSF1R, and c-KIT for the treatment of pulmonary arterial hypertension (PAH)—could be eligible for an approval decision in the third quarter of 2027. The company noted that final approval determinations will depend on the agency’s review of the full NDA package.

Lab (Unsplash)

Alongside its regulatory updates, Gossamer announced it has terminated its Collaboration and License Agreement with Chiesi, reacquiring full worldwide development and commercialization rights for seralutinib. The move consolidates global control of manufacturing, pricing, and commercial strategy under Gossamer while eliminating the previous 50/50 U.S. profit-sharing structure.

Under the terms of the termination, Chiesi will pay Gossamer a one-time fee of $5 million to settle outstanding obligations, including costs from the second quarter of 2026. Gossamer paid no upfront cash to reclaim the rights. In exchange, Chiesi will receive specified regulatory and commercial milestone payments, along with a capped royalty on future worldwide net sales.

“This is a defining moment for Gossamer,” said Faheem Hasnain, Chairman, Co-Founder, and CEO of Gossamer. “Following a very productive and collaborative engagement with FDA at our Pre-NDA Type B meeting and now with the FDA’s final meeting minutes in hand, we are moving forward with a planned NDA submission for seralutinib in PAH in September. After years of disciplined execution, we are now closer than ever to bringing forward what we believe can be a first-in-class, important new medicine for PAH patients who need better options.”

Hasnain added that reacquiring global rights “returns global development and commercialization decisions to Gossamer and secures the substantial majority of the program’s long-term economics for our shareholders, positioning us to realize the full strategic and financial value of seralutinib across PAH and future indications.”

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The company also announced results from a July 14 special stockholders meeting. Shareholders approved proposals connected to a previously completed exchange of Gossamer’s 5.00% Convertible Senior Notes due 2027. Through the transaction, Gossamer exchanged roughly $181.1 million (90.5%) of the $200.0 million total principal for approximately $65.2 million in new 7.50% Convertible Senior Secured First Lien Notes due 2030, alongside applicable equity securities and warrants.

The note exchange reduced the company’s overall debt principal by approximately $115.9 million, leaving around $18.9 million remaining on the 2027 notes.

Stockholders also authorized the board of directors to execute a reverse stock split, which Gossamer expects to implement in or shortly after the third quarter of 2026 to maintain compliance with Nasdaq’s minimum bid price requirements.

On a preliminary basis, Gossamer reported having approximately $57 million in cash, cash equivalents, and marketable securities as of June 30, 2026.

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Gossamer Bio (GOSS) Targets September FDA Submission For Lead Drug Seralutinib

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Source: “AOL Money”