Life science news 25 May 2026: Lilly’s retatrutide delivers bariatric-surgery-level weight loss in Phase 3, two landmark FDA approvals reshape oncology and hepatology, and a UK biotech targets the global AMR crisis.
The week of 17 to 24 May 2026 delivered a dense cluster of clinical, regulatory and dealmaking milestones that underscore the pace of innovation across the global life science sector. Eli Lilly announced pivotal Phase 3 data for retatrutide showing weight loss at levels previously seen only in bariatric surgery, AstraZeneca and Daiichi Sankyo secured FDA approval for Datroway as a first-line treatment for triple-negative breast cancer, and Gilead received the first-ever US approval for a hepatitis delta virus therapy. Lilly also completed its seventh acquisition of 2026 with the purchase of non-viral DNA delivery biotech Engage Biologics, while Bayer won priority review for Kerendia in type 1 diabetes and chronic kidney disease. In the UK, AMR Bio emerged as a new clinical-phase company advancing an innovative antimicrobial strategy ahead of surgery.
Eli Lilly announced on 21 May that its pivotal TRIUMPH-1 Phase 3 trial of retatrutide, a first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, produced weight loss results without precedent in the pharmacological history of obesity treatment. Across 2,339 participants without diabetes, those on the highest 12 mg dose lost an average of 70.3 pounds, representing 28.3% of body weight over 80 weeks, with 45.3% of participants achieving at least 30% weight loss, a threshold long associated exclusively with bariatric surgery. An extension cohort with a starting BMI of 35 or above continued to an average of 85 pounds or 30.3% weight loss at 104 weeks. All three tested doses of 4 mg, 9 mg, and 12 mg met both primary and key secondary endpoints, and the lowest dose arm showed a lower discontinuation rate due to adverse events than placebo. Lilly confirmed it will present full data at the American Diabetes Association Scientific Sessions and that additional TRIUMPH programme readouts in type 2 diabetes and established cardiovascular disease are expected later in 2026. No regulatory submission has yet been filed for retatrutide.
AstraZeneca and Daiichi Sankyo received FDA approval on 22 May for Datroway (datopotamab deruxtecan-dlnk) as a first-line treatment for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitor therapy, making it the first TROP2-directed antibody-drug conjugate approved in the first-line setting for this patient population. The approval was based on data from the Phase 3 TROPION-Breast02 trial, which demonstrated a median overall survival of 23.7 months for Datroway compared with 18.7 months for chemotherapy, with a confirmed overall response rate of 62.5% versus 29.3% for chemotherapy. Triple-negative breast cancer is defined by the absence of hormone and HER2 receptors, historically limiting treatment options to chemotherapy in the first-line setting. The FDA also added Datroway as a Category 1 preferred first-line option in NCCN Clinical Practice Guidelines for patients ineligible for immunotherapy. The application was reviewed under the FDA’s Project Orbis framework, with regulatory reviews continuing in the EU, China, Japan, Canada and other markets.
Gilead Sciences announced on 22 May that the FDA has granted accelerated approval for Hepcludex (bulevirtide-gmod) 8.5 mg for the treatment of adults with chronic hepatitis delta virus infection, making it the first and only FDA-approved therapy for a disease that has carried no approved pharmacological options in the United States until now. Chronic HDV is considered the most severe form of viral hepatitis, progressing rapidly to liver failure and carrying mortality rates of up to 50% within five years in cirrhotic patients. It occurs exclusively in people already infected with hepatitis B, with an estimated 40,000 to 80,000 individuals affected in the United States. The FDA granted the approval based on reductions in HDV RNA and normalisation of alanine aminotransferase levels in the pivotal Phase 3 MYR301 study, in which approximately 48% of patients receiving Hepcludex achieved meaningful improvement after 48 weeks compared with 2% in the delayed treatment arm. Gilead has committed to a confirmatory long-term outcomes study, and the treatment is already approved in Europe under a different dosage. A boxed warning has been issued regarding the risk of severe hepatitis flares on treatment discontinuation.
Eli Lilly completed the acquisition of Engage Biologics on 20 May in a deal valued at up to $202 million in cash, comprising an undisclosed upfront payment plus additional milestone-based payments. The San Carlos, California-based preclinical company is the developer of the Tethosome platform, a non-viral DNA delivery system that pairs lipid nanoparticle-delivered DNA with an mRNA-encoded component designed to improve where and how strongly genetic payloads are expressed, and to address longstanding obstacles in DNA delivery around efficacy, tolerability and re-dosing. The acquisition, Lilly’s seventh of 2026, extends a dealmaking run that has already included purchases of Kelonia Therapeutics for up to $7 billion and Centessa Pharmaceuticals for $7.8 billion earlier this year. Lilly has stated that the Tethosome platform will be integrated into its genetic medicines research organisation, with a strategic aim of expanding beyond metabolic disease into rare disease and other areas. Engage has not disclosed any specific therapeutic programmes.
In further life science news 25 May 2026, Bayer announced on 21 May that the FDA has accepted its supplemental New Drug Application and granted Priority Review for Kerendia (finerenone) in the treatment of adults with type 1 diabetes and chronic kidney disease, which if approved would make it the first new treatment option in this combination of conditions in over 30 years. The submission was supported primarily by data from the Phase 3 FINE-ONE trial, in which finerenone significantly reduced urine albumin-to-creatinine ratio over six months compared with placebo, a marker of kidney disease progression and cardiovascular risk. Kerendia is already approved by the FDA for chronic kidney disease associated with type 2 diabetes and for heart failure with left ventricular ejection fraction of 40% or greater, and the priority review designation means a regulatory decision is expected within six months. Approximately 20 to 30% of people with type 1 diabetes develop chronic kidney disease over time, representing a patient population with significant unmet need.
AMR Bio launched on 20 May as a privately-held, UK-based clinical-phase biotechnology company focused on antimicrobial resistance, advancing a Phase 3-ready topical antimicrobial gel, XF-73 Nasal, designed to prevent post-surgical infections by eliminating harmful nasal bacteria before surgery. The nasal gel is applied prior to surgical procedures in a 24-hour treatment window that uses a mechanism with no detectable resistance development to date. AMR Bio acquired the XF platform from Destiny Pharma following its entry into administration, along with the associated Investigational New Drug application and Fast Track and Qualified Infectious Disease Product designations from the FDA. The MHRA has already granted XF-73 Nasal an Innovation Passport under the Innovative Licensing and Access Pathway, supporting faster UK market access. Post-surgical infections cost the US healthcare system an estimated $10 billion annually, while antimicrobial resistance contributes to nearly five million deaths globally each year, with projections suggesting up to ten million additional deaths annually by 2050 without intervention. The launch reinforces the UK’s position as an active hub for AMR innovation at a time when globally approved treatment options remain critically limited.
That’s your life science news digest for 25 May 2026, back next Monday with the latest from pharma, biotech and healthcare at www.lifesciencedaily.news.
Missed last week’s roundup? Read the Weekly News Roundup for 18 May 2026 here.
This weekly digest is produced by the Life Science Daily News editorial team. All stories are selected and written independently.
