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Gossamer Bio reports clinical, financial, and corporate updates tied to seralutinib, its investigational inhaled tyrosine kinase inhibitor for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Recurring developments include Phase 3 study results, regulatory pathway updates, collaboration activity with Chiesi Group, quarterly financial results, and capital allocation updates.
Company news also covers Nasdaq Rule 5635(c)(4) employment inducement grants under the 2023 Employment Inducement Incentive Award Plan, investor conference participation, and business development or resource-allocation actions related to its pulmonary hypertension strategy.
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Gossamer Bio reported its financial results for Q4 and full year 2022, highlighting a net loss of $55.8 million or $0.59 per share in Q4, and a full-year net loss of $229.4 million or $2.71 per share. Cash, cash equivalents, and marketable securities were $256 million, expected to sustain operations into the second half of 2024. The company plans to initiate a Phase 3 clinical trial for Seralutinib (GB002) in pulmonary arterial hypertension in H2 2023, while enrollment in the Phase 1b/2 GB5121 CNS study is paused.
Gossamer Bio announced promising topline results from the TORREY Phase 2 study of seralutinib in treating pulmonary arterial hypertension (PAH). The primary endpoint, change in pulmonary vascular resistance (PVR) at Week 24, was met with a statistically significant P-value of 0.0310. Secondary endpoints also favored seralutinib, particularly in patients classified as WHO Functional Class III, showing a 21% reduction in PVR and a 37-meter improvement in six-minute walk distance (6MWD). Seralutinib exhibited a favorable safety profile, with most adverse events being mild to moderate.