Antiva Biosciences Inc. has developed an intravaginal topical treatment, ABI-2280, for high-risk cervical infections with human papillomavirus (HPV). In a phase Ib/II study, after two weeks of treatment at the highest dose of the DNA polymerase inhibitor, 46% of patients were negative for high-risk HPV at week 12, compared to just 16% of patients treated with placebo.

The recombinant fusion protein drug telitacicept from Remegen Co. Ltd. and Vor Bio Inc. has notched a phase III win in treating adults with IgA nephropathy. The clinical trial of the fusion protein hit the primary endpoint, reducing proteinuria, too much protein in patients’ urine, in stage A of the study in China.

Summit Therapeutics Inc.’s presentation for bispecific antibody ivonescimab in non-small-cell lung cancer could draw some extra attention at next month’s World Conference on Lung Cancer meeting thanks to promising overall survival data from partner Akeso Pharmaceuticals Inc.’s China study of the PD-1/VEGF candidate.

With new and positive phase III data in treating agitation in patients – at home instead of in a clinic – with bipolar disorders or schizophrenia, Bioxcel Therapeutics Inc. is preparing to submit an sNDA in the first quarter of 2026 to expand the label of the company’s Igalmi (BXCL-501). These data also bring the company closer to having the first such treatment that is approved by the U.S. FDA for home use. The unmet need for patients is huge, Vimal Mehta, the CEO of Bioxcel, told the BioWorld Insider podcast. Watch the interview, below.

Akeso Pharmaceuticals Inc.’s gumokimab (AK-111) and manfidokimab met all primary efficacy endpoints in its phase III trials in active ankylosing spondylitis and in moderate to severe atopic dermatitis, respectively.

French vaccines specialist Osivax SAS has been awarded $19.5 million by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to fund work on its universal influenza A vaccine.

Eli Lilly and Co.’s regulatory ducks are lined up nicely with the latest positive top-line results from the phase III Attain-2 trial testing orforglipron, an oral glucagon-like peptide 1 (GLP-1) receptor agonist, in adults with obesity or overweight and type 2 diabetes.

Amid the increasingly competitive myasthenia gravis drug development space, siRNA candidate cemdisiran met phase III endpoints, with the monotherapy showing numerically higher results than a combination product. Regeneron Pharmaceuticals Inc., which has a worldwide license to cemdisiran from Alnylam Pharmaceuticals Inc., plans to file for U.S. approval in generalized myasthenia gravis, a rare and chronic autoimmune disease leading to life-threatening muscle weakness, in the first quarter of 2026.

The frontiers of xenotransplantation have been further extended with a pig-to-human lung transplant, the first time an organ that is directly exposed to the external environment – with the associated risk of respiratory pathogens – has been transplanted. The genetically modified pig lung remained viable and functional for nine days, after it was transplanted into a 39-year-old man who was declared brain dead following a hemorrhagic stroke.