Gossamer Bio (GOSS) Reports Topline Phase 3 Results for Seralutinib in Pulmonary Arterial Hypertension

Gossamer Bio Inc. (NASDAQ:GOSS) is one of the best penny stocks under $1 to buy right now. On February 23, Gossamer Bio announced topline results from its Phase 3 PROSERA study evaluating seralutinib for Pulmonary Arterial Hypertension/PAH. The study achieved a placebo-adjusted improvement of +13.3 meters in the Six-Minute Walk Distance at Week 24. However, with a p-value of 0.0320, the trial narrowly missed its stringent prespecified statistical alpha threshold of 0.025.

Despite this, the drug showed significant activity in a heavily pre-treated population, where 55% of participants were already on triple or quadruple background therapies. The treatment demonstrated a more pronounced clinical impact in higher-risk patients, a finding consistent with previous Phase 2 data. Secondary endpoints, including a significant reduction in NT-proBNP levels, a key biomarker for heart stress, also favored seralutinib, reinforcing the drug’s non-vasodilatory mechanism of action.

Seralutinib was generally well tolerated, with a safety profile consistent with prior clinical experience. Gossamer Bio Inc. (NASDAQ:GOSS) plans to meet with the FDA to discuss a potential path forward for the drug. In the meantime, the company has paused enrollment in its SERANATA study to further analyze regional discrepancies in placebo responses observed during the PROSERA trial.

Gossamer Bio Inc. (NASDAQ:GOSS) is a clinical-stage biopharmaceutical company that develops and commercializes seralutinib for the treatment of pulmonary arterial hypertension in the US.