Gossamer reports Q2 2026 results, reacquires seralutinib rights from Chiesi
Gossamer says it remains on track to file its seralutinib NDA in PAH in September 2026 after a Pre-NDA meeting with the FDA, while reporting $57.0 million in cash as of June 30, 2026.
Gossamer Bio reported financial results for the quarter ended June 30, 2026, alongside a business update dated August 13, 2026. The company said it held a Pre-NDA Type B meeting with the FDA in mid-June 2026 and has since received the official meeting minutes, which characterized the statistical significance and treatment effect seen in the PROSERA trial as review issues rather than filing issues, along with feedback on the format and content of the planned submission.1
Based on that feedback, Gossamer plans to submit an NDA in September 2026 relying on one adequate and well-controlled study, the Phase 3 PROSERA trial, supported by confirmatory evidence from the Phase 2 TORREY trial and additional analyses; if the FDA accepts the filing, an approval decision could come in the third quarter of 2027.1 The company cautioned that the meeting minutes reflect FDA feedback as of the meeting date, and the agency's final approvability determination will depend on review of the complete NDA.1
Separately, Gossamer and Chiesi agreed to terminate their prior collaboration and license agreement, with Gossamer reacquiring worldwide development and commercial rights to seralutinib, ending the former U.S. 50/50 profit split and restoring ex-U.S. rights to Gossamer.1 Under the termination terms, Chiesi will pay Gossamer $5 million to settle all outstanding and future obligations from the prior deal, including second-quarter 2026 costs.1 Gossamer said it made no upfront payment for the rights, and Chiesi will instead receive a royalty on worldwide seralutinib sales up to a cap, plus potential regulatory and commercial milestone payments.
On the balance sheet, cash, cash equivalents and marketable securities totaled $57.0 million as of June 30, 2026, which Gossamer said should fund operations into the first quarter of 2027.1 Stockholders also approved a prior convertible note exchange and authorized a reverse stock split at a July 14, 2026 special meeting, according to the release.
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