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Lilly's Triple-Hormone Drug Beat Ozempic Head-to-Head, and It Wasn't Close on Weight
Lilly's retatrutide went toe-to-toe with Novo Nordisk's Ozempic in people with diabetes and won on both counts that matter. After 80 weeks, both doses cut A1C, a measure of average blood sugar, by 2.2 points, against 1.8 for Ozempic; only the 12 mg dose's edge was formally statistically significant. Weight loss was the blowout: about 21% on the top dose versus 9% on Ozempic. The catch is tolerability. About 8% of patients on the top dose quit because of side effects, compared with 3% on Ozempic. Retatrutide hits three gut hormones (GLP-1, GIP and glucagon); Ozempic hits one.
Why it matters: Novo's own triple-acting drugs are still in Phase 2, so this widens the gap between the two obesity rivals. Leerink's David Risinger says the data support a premium price before semaglutide's U.S. patent expires in 2032, and he forecasts $15 billion in retatrutide sales that year.
BioPharma Dive →Clinical & Regulatory
Genmab's Two-Target Antibody Halved the Risk of Death in Head and Neck Cancer
Adding petosemtamab, an antibody that grabs two tumor targets (EGFR and LGR5), to the immunotherapy pembrolizumab cut the risk of death by 50% versus pembrolizumab alone in first-line, PD-L1-positive head and neck cancer. The Phase 3 hit both primary endpoints, survival and tumor response, at its first interim look. A University of Chicago physician called it the first positive Phase 3 in these patients in several years.
Genmab →Deals & Money
Astellas Lines Up $285 Million for an Option on a Drug Not Yet in People
Astellas agreed to $285 million in upfront and future option payments for the right to license DAX-044 from Australia's Audax Biosciences, with up to $1.05 billion more in milestones. The drug fuses an antibody to IL-12, an immune signaling molecule, to deliver it into cancer cells. Human testing isn't expected to start until 2027, which makes this a big commitment for a long wait.
BioPharma Dive →Formation Bio Raises $600 Million to Buy Drugs Big Pharma Isn't Chasing
Formation Bio launched a $600 million fund to acquire Phase 1 and Phase 2 drugs, 10 to 15 of them over the next few years, in diseases with high unmet need but little industry development. Each drug lives in its own company, sharing Formation's development team, and gets partnered with pharma once trials show progress. Investors include foundations, endowments and hospitals.
Formation Bio →Policy
HHS Lets Pharmacies Make Six Unproven Peptides, Against FDA Scientists' Advice
HHS, led by Robert F. Kennedy Jr., who says he has used some peptides himself, will stop acting against small compounding pharmacies that make six unapproved peptides, including BPC-157 and TB-500. An FDA advisory panel backed access in July, while FDA staff scientists advised keeping the restrictions. Evidence on safety and effectiveness is sparse, and Public Citizen says peptides should go through normal drug approval.
NPR via KPBS →