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Rona Therapeutics has granted Roche an exclusive worldwide license to Rona’s RNAi candidate targeting activin receptor-like kinase 7 (ALK7) utilizing the company's extrahepatic delivery platform
As per the deal, Rona will receive ~$100M in upfront & near-term milestone payments, plus ~$1.06B in development, regulatory & commercial milestone payments, as well as tiered royalties on…
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P-III trial of survodutide (3.6 or 6mg, QW) in 755 pts, met both co-1EP using treatment-regimen & efficacy estimands. At Wk. 76, weight loss reached up to an average of 13.1% vs 3.1% with PBO, while up to 79.3% vs 32.7% pts achieved ≥5% weight loss (efficacy estimand)
In 2EPs, trial showed reduced HbA1c…
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TRIUMPH-2 assessed retatrutide (4, 9, or 12mg, QW) vs PBO in 1152 pts with T2D & obesity/overweight, with trial using a stepwise dose-escalation approach at Q4W. Lilly plans to file BLA in Q1’27
At 80wks., avg. body weight reductions were 12.7% (4mg), 19.1% (9mg), & 20.8% (12mg) vs 4%, plus A1C reduced by 1.4%,…
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Nanexa has entered into a global exclusive license & collaboration agreement with Novo for the use of its PharmaShell ALD drug delivery technology platform, for certain peptide-based drugs targeting obesity, T2D & other cardiometabolic indications
As per the deal, Novo will receive a global license to Nanexa’s PharmaShell platform for use in ~5 development programs,…
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Genentech has reported topline P-II (CT-388-104) trial data assessing enicepatide (CT-388; QW, SC) vs PBO in 447 adults living with type 2 diabetes and overweight or obesity for 48wks.
Enicepatide met both 1EPs, with dose-dependent reductions in blood glucose & body weight at 48wks. At 24 mg, HbA1c fell 2.65% from 8.1% baseline, while…
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Novo Nordisk has reported the P-III (STEP Young) trial data assessing semaglutide (1.7 or 2.4mg based on weight at start of trial; QW, SC) vs PBO in 165 children (6 to <12yrs.) with obesity, both in combination with a reduced-calorie diet & increased physical activity
Trial met its 1EP of superior BMI reduction at…
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Hanmi Pharm has entered into an exclusive licensing agreement with Genentech for the development, manufacturing, & commercialization of HM17321, for obesity & associated conditions such as T2D & CV diseases, globally, excl. South Korea
As per the deal, Hanmi will receive ~$190M upfront, with additional development, regulatory & commercial milestones representing the total deal…
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The MHRA has expanded market authorization for Imcivree (setmelanotide) to incl. the treatment of obesity & control of hunger in pts (≥4yrs.) with acquired hypothalamic obesity due to hypothalamic injury or impairment
Approval was backed by the global P-II/III (TRANSCEND) trial assessing Imcivree vs PBO in 120 pts with acquired HO, meeting its 1EP with…
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TRIUMPH-2 assessed retatrutide (4, 9, or 12mg, QW) vs PBO in 1152 pts with T2D & obesity/overweight, while TRIUMPH-3 assessed retatrutide (9 or 12mg, QW) in 1949 pts with severe obesity & CV disease; trials used a stepwise dose-escalation approach at Q4W
In TRIUMPH-3, 12mg reduced TGs, non-HDL cholesterol, systolic BP, waist circumference, &…
Novo Nordisk Reports the EC Approval of Wegovy Pill and Wegovy 7.2mg Injection for Weight Management
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The EC approved Wegovy pill (25mg, QD, PO) as an adjunct to lifestyle intervention for weight management in adults with obesity or overweight, with ≥1 weight-related condition; launch expected in H2’26. The EC also approved Wegovy 7.2mg injection in a single-dose pen for obesity
Wegovy pill approval was based on the OASIS clinical trial…

