MBX Biosciences Inc. posted positive top-line phase II study data in treating chronic hypoparathyroidism, positioning itself to take on a U.S. FDA-approved therapy for the rare endocrine disease. MBX’s Avail study of canvuparatide hit its primary endpoint in treating adults, demonstrating statistical significance at week 12 and positive six-month results from the open-label extension study. MBX said it is poised to begin a phase III study of once-weekly canvuparatide next year.
Beijing QL Biopharmaceutical Co. Ltd.’s once-monthly GLP-1 receptor agonist, zovaglutide (ZT-002), met its primary and secondary endpoints in a phase II obesity trial, and QL Biopharm will now advance the GLP-1 to a pivotal phase III study.
A new generative AI model trained on UK Biobank data can simultaneously forecast the risks and timing of developing over 1,000 different diseases a decade into the future. The developers applied similar algorithmic concepts to those used to develop large language models like ChatGPT and Gemini to build the model, using medical records from 402,799 participants in UK Biobank.
Touchstone Innovations Ltd. has described peptide hormone analogues acting as gastric inhibitory polypeptide receptor (GIPR) agonists reported to be useful for the treatment of obesity.
Although the development pipeline for obesity treatments is expanding rapidly, weight loss is often accompanied by a concurrent reduction in lean muscle mass, highlighting the need for novel therapeutic approaches that promote fat loss while preserving muscle. Activin type II receptors (ACTRIIA/B) are regulators of muscle homeostasis, while the glucose-dependent insulinotropic polypeptide receptor (GIPR) plays a role in energy balance and adiposity.
At the ongoing European Association for the Study of Diabetes annual meeting in Vienna, Hanmi Holdings Co. Ltd. presented preclinical efficacy data on HM-15275, a long-acting GLP-1/GIP/glucagon receptor triple agonist developed for the treatment of obesity and its associated metabolic complications.
The dash for MASH is gaining momentum, with Roche AG acquiring 89bio Inc. and its phase III FGF21 analogue, pegozafermin, for treating metabolic dysfunction-associated steatohepatitis, in a deal worth up to $3.5 billion. The Swiss pharma is to pay $14.50 per share, valuing San Francisco-based 89Bio at $2.4 billion, a premium of approximately 52% to 89bio’s 60-day average price on Sept. 17, 2025. Shares of 89bio (NASDAQ:ETNB) gained $6.88, or 85%, to close Sept. 18 at $14.96.
“People have some inability to focus on [Regeneron Pharmaceuticals Inc.’s] pipeline,” which stands as “the most prolific in the industry, I would dare to say,” CEO Leonard Schleifer remarked during the Morgan Stanley health care conference Sept. 8. Most recently, Regeneron bragged on two prospects. The ultra-rare disease fibrodysplasia ossificans progressiva (FOP) took center stage Sept. 17 with news that the phase III Optima trial testing fully human monoclonal antibody garetosmab met its primary endpoint. Separately, Regeneron provided updated analyses of the phase II Courage trial that tested new pairings of GLP-1 receptor agonist semaglutide plus the anti-GDF8/anti-myostatin compound trevogrumab, with or without garetosmab, in obesity.
University of Notre Dame du Lac has disclosed peptide-drug conjugates, their hydrogels and their self-assembling nanofibers comprising glucagon-like peptide 1 receptor (GLP-1R) and/or gastric inhibitory polypeptide receptor (GIPR) and/or glucagon receptor agonists linked to an amphiphile moiety through a hydrophobic or hydrophilic-comprising linker acting as vaccine adjuvants reported to be useful for the treatment of diabetes and obesity.
Although cagrilintide from Novo Nordisk A/S proved less than impressive when paired with GLP-1 agonist semaglutide in a single drug known as Cagrisema, the dual long-acting amylin analogue and calcitonin receptor agonist is looking good as a monotherapy in a subanalysis of the phase III Redefine-1 trial.