H.C. Wainwright reiterates a "Buy" rating and a $2.00 price target for Gossamer Bio Inc. shares. Gossamer prepares to submit a New Drug Application (NDA) for seralutinib in September 2026. Seralutinib treats pulmonary arterial hypertension. This planned submission follows the company's receipt of official minutes from a pre-NDA Type B meeting with the FDA.
The FDA characterized statistical significance and treatment effect from the PROSERA trial as review issues, not filing issues. This development is seen as positive. If the NDA is accepted, an approval decision could come in the third quarter of 2027. Gossamer recently reacquired worldwide rights for seralutinib. The company also reduced its debt. It arranged a private placement of up to $250 million to fund operations through potential FDA approval.