Welcome to the Weekly Rundown where the DDN editors cover this week’s top biotech and pharma news.
Novo bets big on Hengrui’s weight loss pill in $2.6B deal
In an increasingly competitive oral GLP-1 market, Novo set its sights on Hengrui Pharma’s GLP-1/GIP dual receptor agonist that boasts the potential for once-weekly oral dosing. The company agreed to pay Hengrui $300 million up front for rights to the drug, HRS-1596, with milestone payments up to $2.6 billion. Currently, the drug is in Phase 1 trials in China to treat patients with type 2 diabetes and weight management. “Novo has pioneered the field of oral peptides and as leaders, we continuously look to advance our broad and deep oral pipeline across obesity, diabetes and other cardiometabolic diseases through our strong internal capabilities and leading external innovation," said Martin Holst Lange, Executive Vice president, Research & Development and Chief Scientific Officer at Novo in the statement. – Allison Whitten
Regeneron and Sanofi double down on immunology with $1 billion expansion
Sanofi and Regeneron have expanded their long-running immunology alliance in a significant deal that adds four next-generation long-acting antibody programs to the partnership. Regeneron will receive $1 billion upfront, with the potential for up to $7 billion more tied to development, regulatory and commercial milestones. The four new candidates target IL-13, IL-4, IL-4Rα, and a bispecific IL-4xIL-13 — reflecting a broad push into cytokine biology that has already proven productive for the pair through blockbuster drugs like Dupixent. One candidate, REGN20423, a long-acting IL-13 monoclonal antibody, is already in a Phase 1 study for atopic dermatitis, while the remaining three are expected to enter clinical studies in 2027. Under the expanded terms, development and commercialization costs will be split evenly, with future profits shared 50/50 globally, Regeneron leading R&D and Sanofi handling commercial efforts. The deal also gives Regeneron the option to bring Sanofi's investigational TSLP/IL-13 bispecific Nanobody lunsekimig into the collaboration once its Phase 3 COPD studies are complete, potentially extending the alliance's reach into respiratory disease. – Andrea Corona
FDA accepts Roche's application for a BTK inhibitor that could change how we treat MS
For years, multiple sclerosis treatment has operated on a frustrating split: The drugs that work best for relapsing MS don't do much for the progressive form, and vice versa. Fenebrutinib, Roche's investigational BTK inhibitor, is making a case for bridging that divide, and the FDA just agreed it deserves a closer look, granting priority review to the NDA covering both relapsing and primary progressive MS. The clinical data behind that filing is hard to argue with. In the FENhance trials, fenebrutinib cut annualized relapse rates by 51 and 58 percent compared to teriflunomide — that second number translates to roughly one relapse every 17 years, a figure Roche says is the lowest ever recorded in a Phase 3 MS study. Meanwhile in FENtrepid, the progressive MS trial, it held its own against ocrelizumab, a drug that's become the standard of care in PPMS, with hazard ratio curves starting to separate as early as 24 weeks. What makes fenebrutinib mechanistically interesting is that it's a noncovalent BTK inhibitor designed to cross the blood-brain barrier and act on microglia, the brain's resident immune cells increasingly implicated in neurodegeneration. That dual peripheral and central action may be why it shows signals across both disease subtypes. If approved, it would be the first BTK inhibitor cleared for MS and the first high-efficacy oral therapy indicated for both relapsing MS and its progressive form — a meaningful step for patients and a new benchmark for the class. – Andrea Corona
Rare genetic thyroid disease gets first treatment option
For the first time, the FDA approved a therapy for the rare genetic disorder, monocarboxylate transporter 8 (MCT8), also known as Allan-Herndon- Dudley syndrome. The condition is caused by mutations in the SLC16A2 gene that leads to dysfunctional MCT8 transporters, which impacts the delivery of thyroid hormones to the brain. The treatment, Emcitate (tiatricol) from Egetis Therapeutics, is a thyroid hormone receptor agonist that enters cells without assistance from MCT8. The approval was based on results from the ReTRIACt trial, which showed that Emcitate significantly reduced total T3, a crucial thyroid hormone, in the blood. “Today marks a turning point for patients living with MCT8 deficiency and their caregivers, who have waited long for an approved treatment in the United States. Our immediate focus is ensuring that eligible patients can access EMCITATE as quickly as possible,” said Nicklas Westerholm, CEO of Egetis Therapeutics, in the press release. – Allison Whitten
CAR T cell therapy shows promise for lupus in clinical trial
On Monday, Adicet Bio shared that a small Phase 1 trial showed that its off-the-shelf CAR T cell therapy, prula-cel, led 50 percent of patients to experience remission after a year of follow-up. The patients were able to stop taking immunosuppressive therapies, and there were no serious cases of cytokine release syndrome — which recent data suggests occurs in 87 percent of lupus patients in CAR T cell trials, though most cases are mild. The company stated in the press release that they plan to begin a new “pivotal study” in the fourth quarter of 2026. “In a disease where chronic therapy with limited efficacy and significant tolerability and safety considerations remains the standard of care, the prospect of durable, treatment-free remission after a single treatment could be transformative for individuals living with lupus,” said Lloyd Klickstein, Interim Chief Medical Officer at Adicet in the press release. – Allison Whitten
Novartis bets up to $7.8 billion on Abogen's mRNA T-cell engager
Novartis signed a licensing andoption agreement with China's Abogen Biosciences this week, paying $575 million upfront and up to $7.2 billion in milestones for an exclusive worldwide license to ABO2203, an mRNA-encoded CD19xCD3 T-cell engager for autoimmune diseases. Instead of delivering a recombinant protein, the therapy uses mRNA to make the body produce its own T-cell engagers, with the aim of resetting B cells. Abogen says it is the first mRNA-encoded T-cell engager to reach clinical testing in autoimmune disease, and recently published data showed it depleted B cells in three immune thrombocytopenia patients without triggering cytokine release syndrome. Novartis also gets exclusive options on further programs built on Abogen's RNA platform. The deal lands weeks after Novartis paused an autoimmune CAR-T program following three deaths, and adds to a growing run of licensing deals between Western drugmakers and Chinese biotechs. – Andrea Corona
