공지 • May 04
Septerna, Inc., Annual General Meeting, Jun 26, 2026 Septerna, Inc., Annual General Meeting, Jun 26, 2026. 공지 • Apr 13
Septerna, Inc. Announces Initiation of Phase 1 Trial for Oral PTH1R Agonist SEP-479 in Hypoparathyroidism Septerna, Inc. announced the dosing of the first participants in its Phase 1 clinical trial of SEP-479, its potent oral small molecule PTH1R agonist being developed for the treatment of patients with hypoparathyroidism. The Phase 1 clinical trial is a single-ascending dose (SAD) and multiple-ascending dose (MAD) clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SEP-479 in healthy adult volunteers. The randomized, placebo-controlled Phase 1 clinical trial is expected to enroll up to 150 healthy adult participants. Dosing is underway in the SAD portion of the clinical trial, which will evaluate the safety and tolerability of SEP-479 at escalating oral doses. The MAD portion of the clinical trial is designed to evaluate the safety and tolerability of once-daily oral dosing of SEP-479 over multiple days of treatment, with secondary and exploratory endpoints including PK and PD, with the latter assessed by changes in endogenous PTH and serum calcium, as well as other biomarkers. Septerna anticipates reporting data from the trial in late 2026 or early 2027. 공지 • Mar 11
Septerna, Inc. has filed a Follow-on Equity Offering in the amount of $150 million. Septerna, Inc. has filed a Follow-on Equity Offering in the amount of $150 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering 공지 • Mar 02
Septerna, Inc. Announces Positive Phase 1 Data for Sep-631, an Oral Mrgprx2 Nam for the Treatment of Mast Cell-Driven Diseases, and Outlines Initial Phase 2 Development Strategy Septerna, Inc. announced positive results from its Phase 1 clinical trial evaluating SEP-631, a potent and selective oral negative allosteric modulator (NAM) of Mas-related G protein-coupled receptor X2 (MRGPRX2). These findings are consistent with the insurmountable NAM mechanism of SEP-631 observed preclinically and support potent target engagement and functional blockade of MRGPRX2 signaling in humans, providing clinical proof-of-mechanism. Phase 2 Development Strategy: Septerna plans to initiate a Phase 2b clinical trial of SEP-631 in chronic spontaneous urticaria (CSU) in the second half of this year, following the completion of ongoing long-term toxicology studies. Following the CSU study initiation, the company also plans to pursue an open-label study in chronic inducible urticaria (CIndU), specifically in patients with symptomatic dermatographism. In a Phase 1 clinical trial, SEP-631 demonstrated favorable tolerability, once-daily pharmacokinetics and pharmacodynamic evidence of MRGPRX2 pathway inhibition. 공지 • Jan 09
Septerna, Inc. Appoints Mark A. Wilson as Chief Legal Officer Septerna, Inc. has appointed Mark A. Wilson as Chief Legal Officer. Mr. Wilson is an accomplished pharmaceutical and biotech executive with more than 25 years of experience across intellectual property, corporate legal, strategic collaborations and corporate governance matters. Mr. Wilson joins Septerna from Nektar Therapeutics, where he most recently served as Senior Vice President and Chief Legal Officer. In this role, he served as chief attorney and senior manager for the legal, human resources, and information technology departments, and was a member of the company’s executive committee. During his tenure, Mr. Wilson served as lead attorney for several significant global development and commercialization collaborations, strategic corporate transactions and alternative financings, and he was responsible for the company’s global patent strategy. He joined Nektar in 2002 as Patent Counsel and held roles of increasing responsibility, including Vice President of Intellectual Property and General Counsel. Earlier in his career, Mr. Wilson was an associate at Reed & Associates, a patent law firm in Menlo Park, California, where he represented both start-up and Fortune 500 companies. Mr. Wilson holds a J.D. from Seton Hall University School of Law and a B.S. in Pharmacy from Rutgers University College of Pharmacy. He is registered to practice before the U.S. Patent and Trademark Office and is a member of the State Bar of California. 공지 • Sep 30
Septerna Appoints Keith Gottesdiener to its Board of Directors and as Chairperson of R&D Committee of the Board Septerna, Inc. announced the appointment of Keith Gottesdiener, M.D., to its board of directors. A seasoned biotechnology executive with over 30 years of experience advancing medicines from discovery through commercialization, Dr. Gottesdiener will serve as chairperson of a newly constituted R&D Committee of the Board. Dr. Gottesdiener has held leadership roles spanning academia, pharmaceutical R&D, and public biotechnology companies. He most recently served as President and Chief Executive Officer of Prime Medicine, Inc., leading the gene-editing company through IPO. Prior to that, Dr. Gottesdiener served as Chief Executive Officer of Rhythm Pharmaceuticals, Inc., where he oversaw the development and approval of setmelanotide for three indications in rare genetic forms of obesity. Before joining the biotechnology industry, Dr. Gottesdiener spent 16 years at Merck Research Laboratories, where he served as Worldwide Head of Late-Stage Development and Worldwide Head of Early Development, with major program responsibilities for the approval of more than 20 novel therapeutics and over 200 successful IND submissions. Earlier in his career, he was Associate Professor of Medicine at Columbia University College of Physicians and Surgeons. Dr. Gottesdiener previously served on the board of directors of Intercept Pharmaceuticals, Inc. He received his M.D. from the University of Pennsylvania Medical School and his A.B. in Applied Mathematics from Harvard University. 공지 • Apr 30
Septerna, Inc., Annual General Meeting, Jun 17, 2025 Septerna, Inc., Annual General Meeting, Jun 17, 2025. 공지 • Feb 19
Septerna Announces Discontinuation of SEP-786 Phase 1 Clinical Trial and Plans to Advance Next-Generation Oral Small Molecule PTH1R Agonist Septerna, Inc. announced its decision to discontinue the Phase 1 single- and multiple-ascending dose (SAD/MAD) clinical trial of SEP-786 in healthy volunteers. SEP-786 is an oral small molecule agonist of the parathyroid hormone 1 receptor (PTH1R) being developed for the treatment of hypoparathyroidism. Septerna’s decision follows the observation of two unanticipated severe (Grade 3) events of elevated unconjugated bilirubin in the MAD portion of the Phase 1 trial, both of which were without elevations in ALT, AST, and GGT liver enzyme levels. Dosing was discontinued for both study participants, and the bilirubin elevations were reversible. Importantly, there were no events of liver injury, cholestasis, or hemolysis across all participants, and there were no serious adverse events (SAEs) in the Phase 1 trial. In completed 28-day preclinical toxicology studies, SEP-786 was generally well-tolerated, without predicted risk of bilirubin elevation. In response to these Phase 1 events, Septerna has initiated non-clinical studies to investigate the underlying mechanism behind the observed effect. 공지 • Jan 06
Septerna, Inc Appoints Gil Labrucherie as Chief Financial Officer Septerna, Inc. announced the appointment of Gil Labrucherie, CFA, J.D., as Chief Financial Officer. Mr. Labrucherie is a seasoned biopharma executive with more than 25 years of senior leadership experience in finance and legal roles for public biopharmaceutical and technology companies. Mr. Labrucherie most recently served as Chief Financial Officer and Chief Business Officer at ACELYRIN, where he led the company’s finance, accounting, investor relations and corporate communications, and business development organizations. Before that, he served as Chief Financial Officer and Chief Operating Officer of Nektar Therapeutics, where he led financial accounting and public reporting, business and strategic planning, corporate legal, intellectual property, government affairs, information technology and supply chain management, and previously served as Nektar’s Senior Vice President and General Counsel. Earlier in his career, Mr. Labrucherie held executive leadership positions at various high-growth technology companies, and he began his career as a corporate associate at Wilson Sonsini Goodrich & Rosati. Over the course of his career, Mr. Labrucherie has raised more than $1.5 billion in private and public equity capital and helped generate more than $1 billion in realized value from strategic partnering transactions. He currently serves on the board of Rezolute, Inc. Mr. Labrucherie holds a J.D. from the University of California Berkeley School of Law, a B.A. from the University of California Davis, and is a CFA charterholder and a member of the State Bar of California. 공지 • Oct 26
Septerna, Inc. has completed an IPO in the amount of $288 million. Septerna, Inc. has completed an IPO in the amount of $288 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 16,000,000
Price\Range: $18
Discount Per Security: $1.26
Transaction Features: Sponsor Backed Offering