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FDA application seeks approval of inhaled therapy for PAH
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Fusion42 · 28 September 2026 · Fusion42 review
Gossamer Bio has submitted a New Drug Application to the FDA seeking approval for seralutinib, an inhaled therapy for pulmonary arterial hypertension (PAH), supported by data from Phase 3 PROSERA and Phase 2 TORREY studies. The FDA will decide on filing acceptance after initial review later this year.
This Wire brief sits within Fusion42's coverage of Biotech.
◆ ◆ The Wire takeaway
You face a new chance to enter the PAH treatment market as Gossamer’s inhaled seralutinib nears FDA review, opening a doorway for therapies improving exercise capacity in higher-risk patients. Recalibrate your clinical focus to this evolving approval path and patient subset demand now.
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1 source · 28 Sep 2026
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