Press release
Gossamer Bio Announces First Quarter 2023 Financial Results and Provides Business Update
- Feedback on Planned Registrational Program for Seralutinib Received from FDA and EMA following Successful Phase 2 TORREY Study - - Registrational Phase 3
About this update from Gossamer Bio, Inc.
[{"type":"text","content":"\n- Feedback on Planned Registrational Program for Seralutinib Received from FDA and EMA following Successful Phase 2 TORREY Study -\n\n\n- Registrational Phase 3 Clinical Trial in PAH Patients Expected to Initiate in 3Q23 -\n\n\n- Initial TORREY Study Open-Label Extension Data Expected Mid 2023 -\n\n\n- Operational Restructuring Implemented to Prioritize Seralutinib -\n\n\n- $202 million in cash, cash equivalents & marketable securities, as of March 31, 2023 -\n\n\n SAN DIEGO--(BUSINESS WIRE)--\nGossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension (PAH), today announced its financial results for the first quarter ended March 31, 2023, and provided a business update.\n\n\n“Our team continues to build momentum across multiple fronts following the positive results from our Phase 2 TORREY study of seralutinib in PAH patients. With recent feedback from both the FDA and EMA, we are well positioned to commence our registration program,” said Faheem Hasnain, Chairman, Co-Founder and CEO of Gossamer. “We remain on track to begin our Phase 3 clinical trial of seralutinib in the coming months, moving one step closer towards our goal of bringing a potential new medicine to patients suffering from PAH.”\n\n\n“Additionally, we made the difficult decision to undergo an operational restructuring and headcount reduction to prioritize resources around the development of seralutinib. We believe that this restructuring was a necessary step to focus the organization on activities which maximize the potential of seralutinib. We truly appreciate the hard work and dedication of all of our employees, past and present.”\n\n\nSeralutinib (GB002): Inhaled PDGFR, CSF1R and c-KIT Inhibitor for PAH\n\n\n\nGossamer has successfully concluded an End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) and the Scientific Advice process with the European Medicines Agency (EMA) following the completion of its positive Phase 2 TORREY Study in patients with PAH. The Company has reached agreement with both FDA and EMA regarding key design elements of the Phase 3 program and expects to commence a single registrational Phase 3 PAH clinical trial in the third quarter of 2023.\n\n\n\nThe planned Phase 3 clinical tri...