Business
Septerna Highlights Company Progress and Reports Third Quarter 2025 Financial Results
SEP-479 Selected as Next-Generation Oral PTH1R Agonist Development Candidate SEP-631 (MRGPRX2 NAM) Phase 1 Clinical Trial in Healthy Volunteers Ongoing Robust
About this update from Septerna, Inc.
[{"type":"text","content":"SEP-479 Selected as Next-Generation Oral PTH1R Agonist Development Candidate SEP-631 (MRGPRX2 NAM) Phase 1 Clinical Trial in Healthy Volunteers Ongoing Robust Financial Position of $561.6 Million Expected to Support Operations at Least into 2029 SOUTH SAN FRANCISCO, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today highlighted key business updates and upcoming milestones and reported financial results for the quarter ended September 30, 2025. “In the third quarter, we made meaningful progress across our portfolio, highlighted by the selection of SEP-479 as our next-generation PTH1R agonist development candidate for hypoparathyroidism and the initiation of our Phase 1 clinical trial for SEP-631 which targets MRGPRX2 for mast cell-driven diseases,” said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. “Both programs exemplify the power of our Native Complex Platform™ to generate differentiated oral small-molecule GPCR therapies with the potential to address serious diseases across a range of indications. With multiple milestones anticipated in the first half of 2026, we are executing with focus and momentum as we work to deliver meaningful therapies for patients.” Corporate Overview and Anticipated Milestones SEP-479 PTH1R Agonist for Hypoparathyroidism: In September, Septerna announced the selection of SEP-479 as its next-generation, oral PTH1R agonist development candidate. In a seven-day study in healthy cynomolgus monkeys, SEP-479 demonstrated robust, dose-dependent increases in serum calcium and decreases in endogenous parathyroid hormone levels. Based on preclinical studies from multiple species, SEP-479 is projected to have a human half-life supportive of once-daily dosing, aligned with the company’s goal of providing full-day calcium control for patients with hypoparathyroidism.Following the successful completion of the remaining preclinical development activities, Septerna plans to initiate a Phase 1 clinical trial for SEP-479 in the first half of 2026. SEP-631 MRGPRX2 NAM for Mast Cell Diseases: A Phase 1 clinical trial of SEP-631, an oral small-molecule MRGPRX2 negative allosteric modulator (NAM) for the treatment of mast cell diseases including chro...