Asundexian

Regeneron might be ready for competition with its blockbuster drug Eylea, but it’s not clear that investors are. On Thursday morning, the biotech’s leadership fielded question after question about the strength of the eye drug franchise, asking about upcoming competition from Amgen’s biosimilar and mixed revenue results in the third quarter. The company’s overall sales for its Eylea franchise beat the Wall Street expectations by 2% in the third quarter. But the newer version of the drug, Eylea HD, missed by 8%. The stock $REGN was down about 10% in reaction to the results. Things may not get much better three months from now. Last week, Amgen announced it was preparing to launch an Eylea biosimilar years early after winning a legal case against Regeneron in an appeals court. Regeneron has long dominated the market, with the company delivering “somewhere in the neighborhood” of 100 million Eylea injections, CEO Leonard Schleifer said on Thursday’s earnings call. “They say imitation is the best form of flattery, so we’re glad to be flattered by Amgen that they’re spending their time imitating our products,” Schleifer said on the call. “We’re spending our money trying to bring new products to market, which we think is what this industry really is built for. Biosimilars are fine, but we think the industry is built, and Regeneron is best built, to bring innovative products to market.” Regeneron has never been shy about its lack of interest in developing biosimilars, even as other large biotechs have pursued the market. Schleifer and CSO George Yancopoulos co-founded Regeneron in the late 1980s and remain atop the drugmaker’s board, making them one of the longest-standing scientist-led biotechs in the industry. “We know that there is a biosimilar in the market for Eylea, not Eylea HD. And we know it will be competitive, but we think we’ll be able to compete,” Schleifer said. Regeneron has more than 40 drugs in clinical development, Schleifer emphasized on the call. It did cull one asset in the quarter, however: REGN6569, a GITR monoclonal antibody in Phase 1 for solid tumors, a company spokesperson confirmed to Endpoints News . Meanwhile, Regeneron said it could move two factor XI inhibitors into pivotal trials early next year and plans to report proof-of-concept results before the end of this year. Factor XI drugs aim to take advantage of genetic data showing patients with factor XI deficiency — which in some cases can cause a form of bleeding risk — have reduced incidence of myocardial infarction, stroke and other cardiovascular problems. The factor XI field has had its ups and downs. Bayer stopped a large Phase 3 in atrial fibrillation last year but is still pushing ahead with asundexian in other late-stage testing . Johnson & Johnson and Bristol Myers Squibb’s milvexian is also in late-stage testing, as is Blackstone-backed Anthos Therapeutics . Regeneron’s factor XI work includes an A2 domain-focused asset codenamed REGN9933 and a catalytic domain drug called REGN7508. “Our A2 domain antibody is not a complete blocker of factor XI. It actually is more like a complete factor XII blocker. It’s expected to not have as profound an effect on the coagulation pathways but to have a much milder safety profile,” Yancopoulos said on the call. “In contrast, we believe that our catalytic domain antibody is the best-in-class blocker of factor XI. It will come with the best ability to control coagulation among all agents that are attacking this pathway.” The company also said it anticipates finishing enrollment in its Phase 2 obesity trial, which is focused on preserving muscle mass in patients on Novo Nordisk’s semaglutide. Regeneron plans to have results in the second half of 2025 for the study, which is testing an anti-myostatin called trevogrumab in addition to semaglutide with and without the anti-activin A known as garetosmab. “The simplest regulatory will be just by increasing the actual weight loss and then you’ll be able to show secondary endpoints that you’re doing better on composition of weight loss as well,” Yancopoulos said. “That said, we are going to be measuring metabolic parameters and we’re also going to be measuring functional outputs as well.”