Gossamer Bio announced that it has reacquired the ex-US rights to its seralutinib dry powder inhaler for the treatment of pulmonary hypertension from Chiesi, which acquired the rights to the seralutinib DPI in 2024. According to Gossamer, Chiesi will pay $5 million on termination of the previous deal to settle all outstanding commitments and will receive a capped royalty on potential sales and as well as potential milestone payments.
Earlier this year, Gossamer announced that the Phase 3 PROSERA trial of the DPI in patients with pulmonary arterial hypertension had missed its primary endpoint. Despite the trial result, Gossamer said that it planned to meet with the FDA regarding a way forward and now says that it plans to submit an NDA in the near future.
Gossamer Bio Chairman and CEO Faheem Hasnain commented, “This is a defining moment for 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 continued, “Reacquiring the worldwide rights to seralutinib is equally significant. It 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. We enter the second half of 2026 with increased clarity on our planned regulatory path, worldwide rights in hand, a healthier balance sheet and real momentum behind us. There has never been a more exciting time in Gossamer’s history, and we look forward to the milestones ahead.”
Read the Gossamer Bio press release
