Leucovorin Calcium

Welcome back to Endpoints Weekly, and thanks for starting your Saturday morning with us! It’s officially autumn, but the weather here in NYC hasn’t cooled off just yet. Here’s hoping we get a few more days of 70-degree temps before the season fully turns. We had another busy week in biopharma, with no bigger headline than Pfizer jumping back into the obesity space. Our reporters had this story covered from every angle this week, so be sure to read all our in-depth articles in case you missed them earlier! There was more news out of Washington, as President Donald Trump held a press conference to claim, despite conflicting evidence, that Tylenol use during pregnancy may cause or contribute to autism. Trump also threatened pharmaceutical tariffs against companies who don’t manufacture their drugs in the US, and his administration is expected to make a major drug pricing announcement next week. Elsewhere, we have stories on a drug rejection and the end of Biogen’s AAV gene therapy work. Be sure to dive on in, and thanks again for reading. — Max Gelman No, it isn’t teaming up with Taylor Swift or the baseball team from Queens. Rather, Pfizer acquired the GLP-1 biotech Metsera this week for $4.9 billion. The size of the deal can increase to $7.3 billion if all the milestones are reached. Metsera’s most advanced drug, a GLP-1 receptor agonist called MET-097i, is in Phase 2b testing. A once-weekly version of MET-097i is slated to enter Phase 3 in the first half of next year, and a once-monthly formulation is anticipated to begin in the second half of 2026. The biotech is also working on oral peptides. The deal immediately makes Pfizer relevant in obesity again after it sidelined an in-house drug earlier this year due to intolerable side effects. Pfizer will once again aim to take on the market’s GLP-1 leaders in Eli Lilly and Novo Nordisk, and they’ll likely need the Metsera programs to perform as well as their competitors , senior biopharma journalist Elizabeth Cairns writes. Could the buyout also spark M&A from other companies? That’s the question biotech correspondent Kyle LaHucik posed to analysts this week in the wake of Pfizer’s deal. Larger biopharmas much prefer acquisitions to licensing deals, one told Kyle, and it’s possible the industry could see such companies “tiptoeing” into more obesity deals. Read more here . President Donald Trump said on Thursday night that drugmakers have until Oct. 1 to break ground on their manufacturing promises, or face a 100% tariff on brand-name pharma products. In a post on Truth Social, he said the tariff would be imposed next week unless a company is “‘breaking ground’ and/or ‘under construction’” in the US. At the end of the week, the biopharma industry was still trying to assess the situation. Leerink analyst David Risinger said that “many large-cap biopharmaceutical companies should not be exposed because they are engaged in some sort of US facility construction activity, but it is difficult to predict which smaller US biopharma companies may face exposure.” Meanwhile, Endpoints News’ Max Bayer and Drew Armstrong reported on Thursday that the White House could make an announcement as soon as next week about its efforts to reduce drug prices, which could include an update on its most favored nation plan and other price policies. Stay tuned for more. The FDA rejected Scholar Rock’s experimental spinal muscular atrophy drug apitegromab after issues were found at a Novo Nordisk manufacturing site in Indiana. The company said the issues were not specific to apitegromab and that there were no concerns about the safety or efficacy of the drug. It plans to resubmit its application once the issues have been resolved. Novo acquired the Catalent site from Novo Holdings last year. Earlier this year, Regeneron received a complete response letter for Eylea HD after issues were found at the same Indiana site. At the time, Regeneron CEO Leonard Schleifer said the issues were “process” and “procedural” related, without going into much detail. Read more from Anna Brown here. The FDA is calling on GSK to update the label for a drug it stopped selling more than 28 years ago, Zachary Brennan reported this week. The agency claimed a review of medical literature shows the now-generic drug, called leucovorin, might help with autism. During a press conference on Monday, Trump and HHS Secretary Robert F. Kennedy Jr. also claimed that, despite conflicting evidence, Tylenol use during pregnancy may be associated with autism. Patricia Zettler, a professor at Ohio State University and former FDA lawyer, told Endpoints that the “FDA seems to be asking the NDA sponsor to add an indication to this drug, and from what we can tell from what is public, FDA is basing that request on information that seems quite different from what the agency would normally consider to be ‘substantial evidence’ of effectiveness, even for rare diseases.” GSK told Endpoints that it would update the label, at the FDA’s request. But the company said it had no plans to restart manufacturing. The big biotech will end its work on gene therapies that use adeno-associated viruses, following in the footsteps of other companies like Pfizer, Roche, Takeda and Vertex. AAV capsids are expensive to manufacture, and the therapies often carry multimillion-dollar price tags. Some also come with only modest efficacy. It’s not the first time Biogen has cut back on gene therapy. In 2023, early in CEO Chris Viehbacher’s tenure, the company deprioritized its preclinical AAV gene therapy work. But it didn’t scrap all of its early in-human programs. As recently as May, Biogen researchers presented the design of new viral vectors at a gene therapy conference.