FDA panel confronting peptide controversy

NewsletterThe Readout FDA panel confronting peptide controversy You’re reading STAT’s Readout newsletter Manage alerts for this article Email this article Share this article By Meghana KeshavanJuly 23, 2026 Biotech Correspondent Meghana Keshavan[email protected]Meghana Keshavan covers biotech and contributes to The Readout newsletter. Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. The FDA is weighing a politically charged decision on compounded peptides, Revolution Medicines is advancing a promising pancreatic cancer drug toward approval, and new evidence suggests Merck’s Ebola vaccine may help blunt the DRC’s Bundibugyo outbreak.Advertisement The need-to-know this morning Earnings season rolls on, with Roche and Argenx reporting this morning. Verdiva Bio, which is working on obesity drugs, has hired Steve Marso as chief medical officer. He was previously CMO at Metsera, the obesity-focused biotech that Pfizer acquired last year. FDA panel will tackle the peptide issue Americans are increasingly using synthetic peptides — despite scant evidence of their safety or effectiveness. Today and tomorrow, an FDA advisory committee will mull whether compounding pharmacies should be allowed to manufacture seven peptides, in particular. This could mean a clash between career FDA scientists, newly appointed panelists with ties to prescribing peptides, and an HHS leadership that generally supports broader access to these substances, STAT’s Sarah Todd and Lizzy Lawrence write. Although regulating the compounding of peptides could steer patients away from an unregulated gray market, there’s concern that expanding access to them without stronger clinical evidence could legitimize therapies whose risks remain poorly understood. “The key public health question is whether these products should become more widely available before that evidence exists,” said Jason Nagata, an associate professor of pediatrics at University of California San Francisco who recently co-authored an editorial for JAMA on peptides’ regulatory gaps. “Expanding compounding access without a stronger scientific foundation could inadvertently confer a sense of medical legitimacy on products whose safety and efficacy remain largely unknown.” Advertisement Read more. FDA accepts RevMed’s cancer drug submission The FDA has accepted Revolution Medicines’ new drug application for daraxonrasib, moving the company a step closer to the expected approval of its therapy for metastatic pancreatic cancer. The filing is backed by a Phase 3 study that showed the drug resulted in significant improvements in overall survival and progression-free survival over standard chemotherapy, along with delayed worsening of pain and quality of life. The application is being reviewed through the FDA Commissioner’s National Priority Voucher pilot, an expedited program that could shorten the review timeline. GSK gets first-ever lung cancer approval The FDA has approved GSK’s Jideytro for a type of non-small cell lung cancer, giving the U.K. firm its first lung cancer drug as it seeks to build out its oncology portfolio. Jideytro, also known as zidesamtinib, came to GSK through its acquisition of Nuvalent, a deal worth $10.6 billion that was only announced last month. The approval, which came ahead of the FDA target date by nearly two months, covers patients with advanced or metastatic tumors with ROS1 mutations who previously tried an ROS1 kinase inhibitor. Zidesamtinib is also being explored as a first-line treatment. “The rapid progression of Jideytro from development to approval reflects both the strength of the underlying science and the urgent need for additional effective and tolerable treatments for ROS1-positive lung cancer,” GSK Chief Scientific Officer Tony Wood said in a statement. “Today’s approval provides an important new option for these patients and supports our strategy to acquire assets with validated targets that could meaningfully improve standards of care.” GSK, which did not immediately say what the drug’s U.S. list price would be, returned to oncology in recent years after previously leaving the field. It has other lung cancer drug candidates in trials. Arrowhead challenges Ionis in triglyceride drug race Less than a month after Ionis won FDA approval to expand Tryngolza as the first drug specifically indicated for severe hypertriglyceridemia, Arrowhead Pharmaceuticals has unveiled Phase 3 data that could shake up the competitive landscape in this space.Advertisement In two late-stage trials involving roughly 750 patients, Redemplo — or plozasiran — met all primary and secondary endpoints. It cut pancreatitis rates by 78% versus placebo, and reduced triglyceride levels by about 80% after one year. Among the highest-risk patients, Arrowhead reported no pancreatitis. The company plans to file for FDA approval by the end of the year, meaning Redemplo could compete directly with Tryngolza. Notably, its rival Ionis alleged last year that Arrowhead copied its patented mRNA technology to develop Redemplo, FiercePharma notes. Heart benefits of Lilly’s ‘triple-G’ drug still an open question after new data Eli Lilly this morning reported that its next-gen obesity drug helped patients lose substantial weight as expected in a Phase 3 study. But it remains inconclusive how much the drug benefits cardiovascular health. Some of the study’s secondary endpoints looked at the occurrence of major cardiovascular events such as death, heart attack, or stroke. In precified analyses looking at the occurrence of major cardiovascular events such as death, heart attack, or stroke, those on the drug, called retatrutide, did not have a statistically significant lower risk of major events than those on placebo. Lilly said the study, though, was not powered to study cardiovascular outcomes and there fewer heart events that anticipated. People on the highest dose of, though, did experience improvements in cardiovascular risk factors, like triglycerides and cholesterol. Read more from STAT’s Elaine Chen. More reads New study supports testing of Merck’s Ebola vaccine in DRC outbreak, STAT Repligen beefs up cell therapy business with $1.5 billion deal for BioLife, Reuters FDA is urged by advocacy group to ban DTC prescription drug ads, STAT biotechnology, Cancer, drug development, Drug prices, FDA, research Submit a correction requestReprints Meghana Keshavan Biotech Correspondent Meghana Keshavan covers biotech and contributes to The Readout newsletter. Newsletter Understand how science, health policy, and medicine shape the world every day Recommended The Readout July 22, 2026 STAT Plus: Pharma tries to tamp down broad China restrictions D.C. 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