Bayer AG’s oral factor XIa inhibitor asundexian significantly reduced ischemic stroke by 26% in patients following a noncardioembolic ischemic stroke or high-risk transient ischemic attack in the phase III Oceanic-Stroke study.
On the heels of an NDA submission for brepocitinib in dermatomyositis, Priovant Therapeutics Inc. disclosed data showing the dual TYK2/JAK1 inhibitor surpassed expectations in a phase II study in cutaneous sarcoidosis, another chronic inflammatory skin condition with limited treatment options, setting the stage for a phase III study set to start this year.
Following on from a successful phase IIa proof-of-mechanism study in myasthenia gravis, NMD Pharma A/S has added clinical data on a second neuromuscular disorder, reporting positive phase IIa results for ignaseclant, in both type I and type II Charcot-Marie-Tooth disease.
Another data cut from Ultragenyx Pharmaceutical Inc. regarding UX-111 (rebisufligene etisparvovec), an AAV9 gene therapy for type A Sanfilippo syndrome, continued to brighten the picture for the compound, recently taken under review again by the U.S. FDA.
Nearly three months after winning a contentious bid to buy obesity drugmaker Metsera Inc. for $10 billion, Pfizer Inc. reported its first statistically significant top-line data of the acquired lead, ultra-long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, showing a mean placebo-adjusted weight loss of up to 12.3% at 28 weeks, as well as competitive tolerability.
More than four years after a phase II/III trial with Sanofi SA’s oral glucosylceramide synthase inhibitor venglustat was stopped for lack of benefit in autosomal dominant polycystic kidney disease, the company rolled out mixed phase III data from two more efforts.
An AI-based software developed by Screenpoint Medical BV could help detect breast cancers earlier and reduce the number of cancers that appear between routine screenings. In a trial of over 100,000 women, the use of the company’s Transpara Detection system resulted in a 12% reduction in the rate of interval cancers, compared to standard mammography screening. The results from the Mammography Screening with Artificial Intelligence study was published in the Lancet.
BioWorld tracked 215 clinical trial readouts spanning phases I through III in December 2025, a sizeable increase from 170 updates in November, but below the 252 reported in October.
Quince Therapeutics Inc. is scrapping work with dexamethasone sodium phosphate encapsulated in autologous erythrocytes (eDSP) for patients with ataxia-telangiectasia (A-T), and Boral analyst Jason Kolbert said “the core value driver has been effectively removed, and the equity appears fully impaired at this stage.”
With the PDUFA date fast approaching for Regenxbio Inc.’s gene therapy RGX-121, the U.S. FDA placed the drug on clinical hold along with another, RGX-111, after preliminary analysis of a single case of neoplasm (specifically, an intraventricular central nervous system tumor) in a participant treated in the phase I/II study with the latter treatment.
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