Eli Lilly and Co. disclosed positive top-line results from Transcend-T2D-1, a phase III trial evaluating the efficacy and safety of retatrutide, an investigational first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, as an adjunct to diet and exercise. The study enrolled adults diagnosed with type 2 diabetes who had inadequate glycemic control with diet and exercise alone. Their mean duration of disease was 2.5 years. Retatrutide met the primary and all key secondary endpoints, delivering superior A1C reduction and weight loss at 40 weeks vs. placebo, using efficacy as well as treatment-regimen estimands. For the primary endpoint specifically, subjects given the active drug chalked average A1C reductions of up to 2% using the efficacy estimand. For a key secondary endpoint, participants taking retatrutide lost up to an average of 36.6 lbs. (16.8%) by the same measure. Weight loss continued through the end of the treatment period, Lilly said.
Study: GLP-1RAs associated with less risk of mental illness getting worse
In a sea of uncertainty, a large-scale, long-term Swedish study is the first to show that people using GLP-1 receptor agonists are less likely to have worsening mental illness. The study involved a national cohort of 95,490 people diagnosed with depression or anxiety disorder, who also were treated with any diabetes drug (apart from insulin). Among 22,480 individuals prescribed GLP-1s, it was shown that Ozempic (semaglutide, Novo Nordisk A/S) was associated with a 42% reduction in sick leave from work and hospitalization due to psychiatric illness during use of the drug, compared with periods over the 13-year study when the same individuals did not take the drug.
Kintor’s KX-826 meets phase III endpoints in alopecia
Kintor Pharmaceutical Ltd.’s topical androgen receptor antagonist, pyrilutamide (KX-826), met the primary endpoint in a pivotal phase III trial in male androgenetic alopecia (AGA), and the company will soon file an NDA with China’s National Medical Products Administration (NMPA). The pivotal trial was a multicenter, randomized, double-blind, vehicle-controlled phase II/III study with an adaptive design evaluating KX-826 tincture (1.0% and 0.5%) in adult men with AGA in China. On efficacy, both doses applied twice daily showed statistically significant and clinically meaningful improvements in target area non-vellus hair count (TAHC) at 24 weeks: +15.33 hairs/cm² with 1%, +14.46 hairs/cm² with 0.5% and +4.68 hairs/cm² with placebo. The 1% dose improved TAHC by 10.65 hairs/cm² vs. placebo (P<0.0001).
GSK’s IBAT inhibitor wins US FDA nod for cholestatic pruritus
With the U.S. FDA’s approval of GSK plc’s ileal bile acid transporter (IBAT) inhibitor Lynavoy (linerixibat), patients with primary biliary cholangitis no longer need off-label treatments for an annoying internal itch symptom called cholestatic pruritus. Approval of the orphan drug came a few weeks after GSK licensed exclusive worldwide rights to the product to Alfasigma SpA in return for $300 million up front and another $100 million tied to the approval, which arrived five days ahead of the March 24 PDUFA date. The March 9 deal was announced amid a rising competitive threat from Mirum Pharmaceutical Inc.’s IBAT inhibitor volixibat, a breakthrough therapy that showed significant pruritic improvement in 2024 from the phase IIb Vantage study.
Minimed secures FDA nod for next-gen insulin pump
Minimed secured U.S. FDA approval for Minimed Flex, its next-generation discreet, smartphone-controlled insulin pump. The nod from the FDA follows the company’s debut on Nasdaq March 6. About half the size of the Minimed 780G pump and roughly the size of two stacked insulin vials, the screenless pump was designed in collaboration with people living with diabetes to offer a more intuitive, lifestyle‑friendly way to manage the condition.
Crossbow raises $77M series B for T-cell mimicking antibodies
Crossbow Therapeutics Inc. closed a $77 million series B round to support an ongoing phase I Crosscheck-001 trial of lead program, CBX-250, and additional T-Bolt immunotherapies targeting a broad range of cancers. Crossbow is developing a broad portfolio of novel TCE therapies that potently target pHLA on cancer cells, using antibodies that mimic T-cell receptors (TCR-mimetics). Called T-Bolt molecules, the candidates can be adapted to address a broad range of malignancies, according to the company.
Embecta acquires Owen Mumford for £150M
Embecta Corp. agreed to acquire Owen Mumford Holdings Ltd. for up to £150 million (US$200 million) in a bid to boost its drug delivery platforms and medical device technologies. Specifically, the deal will bring to Embecta’s portfolio Owen Mumford’s Aidaptus auto-injector, a two-step, single use platform designed to accommodate both 1mL and 2.25 mL prefilled glass syringes in the same base device.
FDA, NIH mark milestones toward reducing animal testing
In what the U.S. FDA has dubbed a milestone move toward fewer animal studies in drug development, the agency published a draft guidance today to help sponsors validate new approach methodologies that can bring safe, effective drugs to market sooner based on human-centric data rather than nonclinical animal pharmacology and toxicology data. At the same time, the NIH is advancing the agenda by providing more than $150 million in awards to develop and scale research methods that better simulate human biology and reduce reliance on animal models.
ESMO TAT: Targeted radionuclide therapy on the rise
Once confined to a niche in nuclear medicine, targeted radionuclide therapy is rapidly gaining momentum and becoming one of the fastest-growing strategies in oncology. Evidence of this surge was clear at the 2026 European Society of Medical Oncology Targeted Anticancer Therapy (ESMO TAT) congress, where the topic was highlighted both at the ESMO Colloquium and in the session entitled “The Future of Radioligands: Insights from Industry, Regulation and Clinical Practice,” with various speakers sharing their perspectives on the modality’s current role and future potential.
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