Septerna, Inc.

SOUTH SAN FRANCISCO, Calif., Feb. 10, 2026 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced that the company will present data from its Phase 1 clinical trial of SEP-631 at the 2026 American Academy of Allergy Asthma & Immunology (AAAAI) Annual Meeting, taking place February 27-March 2, 2026, in Philadelphia. SEP-631 is a selective oral small molecule Mas-related G protein-coupled receptor X2 (MRGPRX2) negative allosteric modulator (NAM) being developed for the treatment of chronic spontaneous urticaria (CSU) and other mast cell-driven diseases. Poster Presentation Details: Title : First-In-Human, Proof-of-Mechanism Phase 1 Study of the Oral MRGPRX2 Antagonist SEP-631 Utilizing Short Wave Infrared Imaging to Assess Response to an Icatibant Skin Challenge Poster Number: L58 Session: Late Breaking Poster Session II Session Date and Time: March 1, 2026, 9:45-10:45 a.m. ET Location: Pennsylvania Convention Center, Level 2, Hall E About SEP-631 Septerna is developing SEP-631, a selective oral small molecule Mas-related G protein-coupled receptor X2 (MRGPRX2) negative allosteric modulator (NAM) for the treatment of patients with chronic spontaneous urticaria (CSU) and other mast-cell driven diseases. MRGPRX2 is known to play an important role in mast cell activation and degranulation which, in combination with other inflammatory mediators, lead to debilitating symptoms for patients. In addition to CSU, MRGPRX2 is highly and uniquely expressed on mast cells implicated in multiple diseases, including asthma, atopic dermatitis, interstitial cystitis, and migraine. In preclinical studies, SEP-631 demonstrated potent and long-lasting inhibition of MRGPRX2 and blocked mediator-induced skin extravasation in mice engineered to express the human MRGPRX2 receptor. About Septerna Septerna, Inc. is a clinical-stage biotechnology company with a world-class team of GPCR experts and drug developers advancing cutting-edge science to unlock the full potential of GPCR therapies for patients with significant unmet needs. The company’s proprietary Native Complex Platform™ is designed to enable new approaches to GPCR drug discovery and has led to the development of a diverse pipeline of novel oral small molecule drug candidates. Septerna is advancing programs in endocrinology, immunology and inflammation, metabolic diseases and additional therapeutic areas, both independently and with partners. For more information, please visit . Investor Contact: Renee Leck, THRUST renee@thrustsc.com Media Contact: Carly Scaduto, THRUST carly@thrustsc.com

Yarrow, financially backed by founder RTW Investments, will pay $70 million upfront for ex-China rights to a potentially first-in-class TSHR antibody drug.\n U.S.-based Yarrow Bioscience is branching out, picking an autoimmune thyroid disease drug from China as its lead candidate.Through a potential $1.37 billion deal, New York-headquartered Yarrow gains ex-China rights to a potential first-in-class antibody targeting the thyroid-stimulating hormone receptor (TSHR) for the treatment of Graves’ disease and thyroid eye disease.The candidate, coded GS-098, was developed by Shanghai Scizeng Medical Technology, a subsidiary of Changchun GeneScience (GenSci) Pharmaceutical.Yarrow, financially backed by its founder RTW Investments, will pay GenSci\'s Scizeng $70 million upfront and $50 million in near-term development milestone payments. The deal could eventually be worth up to $1.365 billion, with Scizeng entitled to tiered double-digit royalties on the drug’s future ex-China sales.“This collaboration represents a tremendous opportunity for Yarrow and GenSci to advance GS-098 (YB-101) toward meaningful clinical milestones in both Graves’ disease and thyroid eye disease,” Rebecca Frey, Yarrow CEO and RTW venture partner, said in a Dec. 15 release, adding that the drug’s mechanism of action “has the potential to transform the treatment landscape.” The molecule was designed to bind to TSHR and thereby block its autoantibody-induced activation. It inhibits the synthesis and release of thyroid hormones, suppresses the proliferation of thyroid cells and prevents the release of inflammatory factors that contribute to hyperthyroidism and related eye conditions, GenSci’s parent company, Changchun High-Tech, explained in a securities filing (Chinese) to the Shenzhen Stock Exchange.In August 2024, GenSci obtained clearance from U.S. and Chinese authorities to begin clinical trials of GS-098 for thyroid-associated eye disease, and then a green light to test the medicine in China for Graves’ disease this October.  TSHR is an emerging target in autoimmune thyroid disease. Ollin Biosciences launched in September with $100 million and Jason Ehrlich, M.D., developer of Roche’s blockbuster eye disease med Vabysmo, at the helm. One of the biotech’s named assets is a preclinical TSHF/IGF-1R bispecific antibody that the firm plans to develop in thyroid eye disease and Graves’ disease.Other companies working on TSHR include Crinetics Pharmaceuticals, Merida Therapeutics and Septerna, which are all still in preclinical stage. GenSci and its parent, Changchun High-Tech, represent the recent trend in which established pharmaceutical companies in China are beefing up their capabilities and ambitions in innovative drugs. Other large Chinese pharma companies, such as Fosun Pharma, Hengrui Pharma and Sino Biopharma, have all made major business development deals this year. 

Dive Brief:Novo Nordisk is again looking for help outside its own laboratories as it works to build on the success of Ozempic and its sister medicine Wegovy.In the latest deal, Novo will provide research funding for Replicate Bioscience as well as up to $550 million in payments to work on new treatments for obesity, Type 2 diabetes and other cardiometabolic disorders.The agreement includes an unspecified amount of cash upfront as well as money tied to certain milestones, Replicate said Thursday.Dive Insight:Novo vaulted into the ranks of the worlds most valuable drugmakers in recent years after introducing Ozempic for diabetes and Wegovy for obesity. Rival Eli Lilly had similar success with its entrants into the GLP-1 drug class. But both companies failed to keep up with demand, and supply shortages opened the door to cheaper compounded versions that continue to hold back growth.In July, Novo cut its financial forecasts, sending its shares spiraling. The company also lost its CEO, Lars Fruergaard Jrgensen, who announced plans to step down in May. Company veteran Maziar Mike Doustdar took over the top job this month.Against that backdrop, Novo has remained active building out its research pipeline. The deal with Replicate follows collaborations announced last year with three different companies backed by Flagship Pioneering. In May of this year, Novo inked a deal with the biotechnology company startup Septerna to work on developing pills for obesity.Replicate specializes in self-replicating RNA. The idea is to build on the success of messenger RNA products by designing medicines that can spur the body to make more therapeutic proteins that last longer. Co-founder Nathaniel Wang has described the process as delivering a copy machine into the cell along with the instruction manual that comes with messenger RNA.For Novo, the new deal expands on previous investments into various forms of RNA technology. In 2021, the Danish drugmaker agreed to a $3.3 billion purchase of Dicerna Pharmaceuticals, a specialist in RNA interference drugs. Last year, the company announced plans to buy RNA drug developer Cardior and its experimental heart failure treatment for as much as $1 billion. '