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Sagimet Biosciences Reports Third Quarter 2024 Financial Results and Provides Corporate Updates
Denifanstat received Breakthrough Therapy designation from FDA for MASH Results from Phase 2b FASCINATE-2 study of denifanstat published in The Lancet
About this update from Sagimet Biosciences Inc. - Series A
[{"type":"text","content":"Denifanstat received Breakthrough Therapy designation from FDA for MASH Results from Phase 2b FASCINATE-2 study of denifanstat published in The Lancet Gastroenterology & Hepatology Successful completion of end-of-Phase 2 interactions with FDA on the development of denifanstat for MASH; Phase 3 program initiation expected by end of 2024 Anticipated cash runway through 2025, with cash, cash equivalents and marketable securities totaling $170.0 million as of September 30, 2024 SAN MATEO, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported financial results for the third quarter ended September 30, 2024, and provided recent corporate updates. “As we approach the end of 2024, the Sagimet team remains focused on advancing denifanstat towards a pivotal Phase 3 program in MASH,” said David Happel, Chief Executive Officer of Sagimet. “The publication of our Phase 2b FASCINATE-2 study results in a highly regarded Lancet journal highlighted denifanstat’s strong efficacy and tolerability data and its highly differentiated mechanism of action which enables denifanstat to improve the key drivers of MASH: fat accumulation, inflammation, and fibrosis. In addition, we are proud to have recently received Breakthrough Therapy designation for denifanstat in MASH from the FDA, demonstrating denifanstat’s potential to address the significant unmet need for new therapies for this serious disease, and, with the successful completion of end-of-Phase 2 interactions with FDA, we look forward to initiating our planned Phase 3 program for denifanstat by the end of 2024.” Recent Corporate Highlights On October 29, Sagimet announced the successful completion of end-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA), supporting the advancement of denifanstat into Phase 3 development in metabolic-dysfunction associated steatohepatitis (MASH). The planned program will include two Phase 3 trials: FASCINATE-3, evaluating patients with F2/F3 (non-cirrhotic) MASH, and FASCINIT, evaluating patients with suspected or confirmed diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD)/MASH.On October 11, the Company announced the publication of results fr...