Sofetabart mipitecan

Welcome back to Endpoints Weekly! Q1 earnings season is officially upon us. Max Gelman kicked off our coverage this week with a story about Johnson & Johnson’s confidence in navigating biosimilar competition to Stelara. We also covered landmark results for Revolution Medicines’ pancreatic cancer drug, a flurry of news from DC, and another acquisition for Eli Lilly. Don’t miss John Carroll’s Q1 deals report, where he dives into the numbers on recent M&A activity. We’ll be back next week! — Nicole DeFeudis Pancreatic cancer has one of the poorest prognoses in oncology. But Revolution Medicines’ daraxonrasib achieved a stunning Phase 3 victory this week when it doubled patients’ survival time compared to chemotherapy. Individuals with metastatic pancreatic ductal adenocarcinoma survived for a median 13.2 months compared to 6.7 months with chemotherapy. That translates to a 60% reduction in the risk of death. The company quickly took advantage, putting together a $2 billion raise made up of a $1.5 billion stock offering and $500 million in convertible senior notes. It initially sought $750 million in stock and $250 million in notes. Revolution was rumored to be in buyout discussions earlier this year, potentially for roughly $30 billion, but nothing ever materialized. How much would an acquisition be worth now? The answer could be worth tens of billions of dollars , and some argue that the stock is fundamentally cheap. Read more from Max Gelman here . It was a busy week in Washington. The FDA announced plans to reclassify a dozen peptides, in a move that HHS Secretary Robert F. Kennedy Jr. said will begin to “restore regulated access and will immediately begin shifting demand away from the black market.” It isn’t clear where the products will be reclassified, though there is only one category that’s more lenient. Two of the peptides being moved are among the most well-known: BPC-157 and TB-500, a combination otherwise known as the “Wolverine stack,” which has been billed as a treatment to help with recovery, repair and inflammation. The move caught the attention of telehealth companies, with Hims & Hers medical chief Pat Carroll announcing that the company was “actively exploring how to expand access.” A draft notice posted in the Federal Register ahead of the announcement scheduled a meeting of the agency’s Pharmacy Compounding Advisory Committee on July 23 and 24 to discuss the reclassification. Meanwhile, a new CDC director was nominated. President Donald Trump picked Erica Schwartz, a former deputy surgeon general and Coast Guard veteran, to lead the agency. Max Bayer has more information here . Endpoints reported this week that the FDA is getting closer to announcing a new director for the Center for Biologics Evaluation and Research, following the tenure of outgoing leader Vinay Prasad. You can read more here about Houman Hemmati, a leading candidate for the post. Former FDA cancer chief Richard Pazdur sat down with Zachary Brennan for a wide-ranging interview on Commissioner Marty Makary’s priorities, agency staffing levels and the role of China in the biotech industry. Pazdur spoke about what he said has traditionally been a firewall between each administration’s political appointees and the federal employees carrying out the drug reviews. “There really was a firewall between the Commissioner’s Office and the review divisions, and obviously that has been breached,” Pazdur said. Read more here. US regulators want more safety information on Eli Lilly’s newly approved obesity pill Foundayo, saying the agency is looking for data on cardiovascular and liver safety risks . Specifically, the drug’s approval letter wanted data to determine the risks of “major adverse cardiovascular events (MACE), drug-induced liver injury (DILI)” and exposure during lactation. A Lilly spokesperson downplayed the risk, saying drug reviews “haven’t identified a new risk.” The obesity pill is also headed for another FDA submission, this time in diabetes. Foundayo cut the risk of cardiovascular events like heart attack and stroke by 16% versus a form of insulin, and the trial found no sign of hepatic toxicity. The results come from the same trial in which the FDA requested more data. A decision could come as soon as the second half of this year, as Lilly hopes to fast-track its application under the Commissioner’s National Priority Voucher program. Biotech entrepreneur Michael Torres is selling his antibody-drug conjugate startup CrossBridge Bio to Eli Lilly for up to $300 million. The announcement comes just a couple weeks after Lilly made a splash with its deal for Centessa Pharmaceuticals. CrossBridge has been working on better linkers for ADCs, and was introduced to Lilly at the JP Morgan Healthcare Conference in 2025. The Houston-based biotech expects its lead program, a TROP2-targeting dual-payload ADC, to enter the clinic sometime this year. But Torres has suggested the technology could apply to other areas beyond cancer. “If this platform works as well as I think it can, Lilly is going to look like geniuses for decades, because of what this could potentially unlock even outside of oncology,” he said. Lilly has been building out its presence in ADCs with small acquisitions, including 2023 deals for Mablink Bioscience and Emergence Therapeutics. One of Mablink’s assets, now called sofetabart mipitecan, started a Phase 3 study in ovarian cancer last fall. Andrew Dunn puts the deal in context here. The Cochrane Database of Systematic Reviews published a study this week claiming antibodies that target sticky amyloid beta proteins in the brain simply don’t work. But that headline belies the methodology of the analysis : It included 15 trials for drugs that failed or were withdrawn. Two other trials — one each for Lilly’s Kisunla and Eisai and Biogen’s Leqembi — were also included. Researchers were quick to point that out. “It should be no surprise that if you average 15 studies for drugs that don’t work with two studies for drugs that do work, that the average result shows that, as a class, these drugs don’t work,” Andrew Budson, associate director of the Boston University Alzheimer’s Disease Research Center, told Endpoints. Read more from Ryan Cross here . DON’T MISS: