Septerna, Inc. is a clinical-stage biotechnology company, which engages in pioneering a new era of G protein-coupled receptor oral small molecule drug discovery powered by proprietary Native Complex PlatformTM. Its pipeline of product candidates focused initially on treating patients in three therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases. The company was founded by Robert Joseph Lefkowitz, Arthur Christopoulos, Patrick Sexton, and Jeffrey T. Finer in December 2019 and is headquartered in South San Francisco, CA.
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- Septerna will present Phase 1 clinical trial data for SEP-631, an oral MRGPRX2 negative allosteric modulator, at the 2026 AAAAI Annual Meeting in Philadelphia. - SEP-631 targets MRGPRX2, a receptor crucial for mast cell activation and degranulation that contributes to debilitating symptoms in chronic spontaneous urticaria and other inflammatory conditions. - The first-in-human study utilizes innovative short wave infrared imaging to assess drug response through icatibant skin challenge testing. - Preclinical studies demonstrated SEP-631's potent and long-lasting MRGPRX2 inhibition and ability to block mediator-induced skin extravasation in humanized mouse models.
- Monash University has established the Monash Boston Hub in Cambridge to deepen collaborations with North American and European biotech companies for drug discovery and health innovations. - The university has completed over 160 license deals and created 30+ spinout companies in the past five years, collectively raising nearly $1 billion in investment. - The Hub will be staffed by 5-7 development professionals and aims to accelerate licensing deals, clinical trial collaborations, and partnerships with global biotech innovators. - Monash has existing partnerships with major companies including Moderna, CRISPR Therapeutics, and Seaport Therapeutics, demonstrating its proven track record in translating research into commercial applications.
- Septerna has appointed Keith Gottesdiener, M.D., a veteran biotechnology executive with over 30 years of experience, to its board of directors and as chairperson of a newly constituted R&D Committee. - Dr. Gottesdiener brings extensive leadership experience from Prime Medicine, Rhythm Pharmaceuticals, and Merck Research Laboratories, where he oversaw the approval of more than 20 novel therapeutics. - The appointment comes at a pivotal time as Septerna advances its GPCR-targeted drug pipeline, including the promising PTH1R program for hypoparathyroidism. - Septerna's proprietary Native Complex Platform™ enables novel approaches to GPCR drug discovery and has led to a diverse pipeline of oral small molecule drug candidates.
- Novo Nordisk has entered a $550 million partnership with California-based Replicate Bioscience to develop RNA-based treatments for obesity and diabetes using self-replicating RNA technology. - The collaboration centers on Replicate's self-replicating RNA platform, which includes cellular machinery to make copies of mRNA therapy inside cells to amplify therapeutic doses compared to traditional mRNA approaches. - This deal represents Novo's continued investment in expanding its cardiometabolic pipeline amid challenges with Wegovy sales and supply shortages from compounded versions. - The partnership follows several other major deals this year, including collaborations worth billions with Valo Health, United Laboratories International, and Deep Apple Therapeutics.
- Septerna has begun dosing the first participants in a Phase 1 clinical trial of SEP-631, an oral small molecule targeting MRGPRX2 for chronic spontaneous urticaria treatment. - The randomized, placebo-controlled trial will enroll up to 150 healthy volunteers to evaluate safety, tolerability, and pharmacokinetics of the novel mast cell activation inhibitor. - SEP-631 represents a potential breakthrough for CSU patients who struggle with inadequate symptom relief from current antihistamine therapies. - The compound also shows promise for treating other mast cell-driven diseases including asthma, atopic dermatitis, interstitial cystitis, and migraine.
- Novo Nordisk and Septerna have formed a $2.2 billion collaboration to develop oral small molecule therapies targeting GLP-1, GIP, and glucagon receptors for obesity and cardiometabolic diseases. - The partnership combines Novo Nordisk's expertise in metabolic diseases with Septerna's proprietary Native Complex Platform™ technology for G protein-coupled receptor (GPCR) drug discovery, addressing a significant untapped opportunity in GPCR therapeutics. - Septerna will receive over $200 million in upfront and near-term payments, with both companies jointly conducting research through candidate selection before Novo Nordisk assumes global development responsibilities.
- Novo Nordisk has committed $2 billion to develop a novel "triple G" weight loss injection in China, expanding its portfolio beyond its successful GLP-1 medications Ozempic and Wegovy. - The investment follows Novo Nordisk's recent $2.2 billion collaboration with Septerna to develop oral obesity therapies, highlighting the company's aggressive expansion in the global obesity treatment market. - This strategic move into the Chinese market addresses the growing obesity epidemic in Asia, where approximately 5% of China's 1.4 billion population is classified as obese, representing a significant untapped market opportunity.
- Septerna discontinues Phase 1 trial of SEP-786, an oral PTH1R agonist for hypoparathyroidism, following two cases of severe elevated unconjugated bilirubin in multiple-ascending dose study. - Despite early signs of target engagement with increased serum calcium and decreased PTH levels, the company pivots to advancing alternative PTH1R agonist candidates with distinct chemical structures. - Company maintains strong financial position with $440.1 million in resources, supporting operations through 2027 while advancing multiple programs including SEP-631 for mast cell diseases.
• Septerna successfully completed an upsized IPO raising $288 million, selling 16 million shares at $18 each, demonstrating strong investor confidence in clinical-stage biotech companies. • The company's lead drug candidate SEP-786, targeting hypoparathyroidism, recently entered Phase 1 clinical trials with data expected by mid-2025. • Septerna plans to allocate $117 million of the proceeds to advance SEP-786 and $37 million for developing SEP-631 for chronic spontaneous urticaria and mast cell conditions.
- Septerna has commenced a Phase 1 clinical trial for SEP-786, a novel oral small molecule agonist targeting the parathyroid hormone 1 receptor (PTH1R). - The trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SEP-786 in healthy adult volunteers. - SEP-786 is being developed as a potential disease-modifying treatment for hypoparathyroidism, offering convenient, full-day calcium control. - The Phase 1 trial includes single-ascending dose (SAD) and multiple-ascending dose (MAD) segments, enrolling up to 180 participants.
