The Aleth Briefs trace each story to its original source and show how the week unfolded.
The week in four lines
Insilico completed Hong Kong’s largest biotech IPO of 2025
Mereo and Ultragenyx‘s bone drug missed its fracture endpoints.
Vanda won approval of the first new motion-sickness drug in 40 years.
A judge blocked the US 340B rebate pilot.
In this edition
Tuesday 30 December
Genmab dropped acasunlimab, its phase 3 lung-cancer bispecific antibody.
Genmab will stop developing acasunlimab after a portfolio review, redirecting resources to Epkinly, petosemtamab and rinatabart sesutecan (Rina-S). The bispecific had reached phase 3 in non-small cell lung cancer, alone and with Merck & Co’s Keytruda, in patients progressing after checkpoint inhibition. BioNTech returned its rights in 2024. Genmab said the data were encouraging but it would prioritise higher-impact late-stage programmes in a crowded field.
Setrusumab missed the fracture endpoint in both phase 3 trials, hitting Ultragenyx and UK partner Mereo.
Setrusumab missed its primary endpoint in both pivotal osteogenesis imperfecta trials. ORBIT compared 159 patients aged 5–25 with placebo, while COSMIC compared 69 children aged 2–6 with intravenous bisphosphonates. Neither study significantly reduced annual clinical fractures, although both improved bone mineral density and showed a consistent safety profile. The companies blamed an unexpectedly low fracture rate in ORBIT’s placebo group. Both shares fell sharply.
Ultragenyx Announces Phase 3 Orbit and Cosmic Results for Setrusumab (UX143)
Phase 3 ORBIT and COSMIC results - Mereo BioPharma
A federal judge blocked the US 340B rebate pilot a day before it was to start.
A Maine district judge granted a nationwide preliminary injunction blocking HRSA’s 340B Rebate Model Pilot Program from launching on 1 January 2026. The court found HRSA likely acted arbitrarily by failing to consider hospitals’ longstanding reliance on upfront 340B discounts before shifting to full-price purchases followed by rebates. The order blocks nine manufacturers’ applications covering ten drugs and applies to all 340B providers, not only the hospital groups that brought the case.
American Hospital Association v Kennedy: order on motion for preliminary injunction - US District Court for the District of Maine
Insilico Medicine raised HK$2.3bn in Hong Kong, the year’s largest biotech listing there.
AI drug-discovery company Insilico Medicine listed on the Hong Kong Stock Exchange, raising about HK$2.28 billion ($293m) at HK$24.05 a share, the largest Hong Kong biotech IPO of 2025. The Hong Kong retail tranche was oversubscribed 1,427 times and the international offering 26 times, with 15 cornerstone investors including Eli Lilly and Tencent. Insilico uses generative AI to design drug candidates and runs programmes in fibrosis, immuno-oncology and cardiometabolic disease.
Vanda’s Nereus, the 1st new motion-sickness drug in >40 years, was approved
The FDA approved Vanda Pharmaceuticals’ Nereus (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, to prevent motion-induced vomiting in adults. It is the first new pharmacological treatment for motion sickness in >40 years. In the Motion Syros trial (365 participants) and Motion Serifos (316 participants), vomiting rates on Nereus ran at roughly 10% to 20% against 38% to 44% on placebo. The clearance was the FDA’s final new drug approval of 2025.
Wednesday 31 December
The FDA rejected Corcept’s relacorilant for hypertension secondary to hypercortisolism.
The FDA issued a complete response letter for Corcept Therapeutics’ relacorilant in hypertension caused by Cushing’s syndrome. Although the phase 3 GRACE trial met its primary endpoint, the agency said GRADIENT’s failure on systolic blood pressure left insufficient evidence of effectiveness to establish a favourable benefit-risk profile. Corcept, which positioned relacorilant as a cleaner successor to Korlym, plans to discuss a path forward with the FDA.