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.

PD-1/VEGF bispecific hits survival endpoint in lung cancer trial

Summit Therapeutics Inc.’s presentation for bispecific antibody ivonescimab in non-small-cell lung cancer (NSCLC) could draw a crowd at next month’s World Conference on Lung Cancer meeting in Barcelona following updated overall survival (OS) data from partner Akeso Pharmaceuticals Inc.’s China study of the PD-1/VEGF candidate. Akeso, which gained NMPA approval for ivonescimab in 2024 based on progression-free survival (PFS) from the Harmoni-A study, disclosed in its midyear earnings report that the final OS analysis also hit statistical significance. The latest OS findings could bode well for Summit’s regulatory plans for ivonescimab, which hit its PFS endpoints in the first global NSCLC trial but fell short of OS significance at the time of analysis.

Vor and Remegen post another phase III win

The recombinant fusion protein drug telitacicept from Remegen Co. Ltd., of Yantai, China, and Vor Bio Inc., of Cambridge, Mass., 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. It was telitacicept’s second phase III win in the month of August, after meeting the primary endpoint in treating Sjögren's syndrome. The drug is approved in China for systemic lupus erythematosus, rheumatoid arthritis and generalized myasthenia gravis.

Europe approves Bio-Thera’s Stelara biosimilar

Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19. The approval grants the use of Usymro for three conditions including: moderate to severe plaque psoriasis when condition has not improved with, or patients are intolerant to, other systemic psoriasis treatments (ciclosporin, methotrexate or psoralen ultraviolet A); active psoriatic arthritis that progresses despite treatment with disease-modifying anti-rheumatic drugs; and moderate to severe Crohn’s disease that does not improve with other treatments.

Research uncovers gene variant role in disease biology

New research has filled in missing links between gene variants that have been implicated in disease through genome-wide association studies (GWAS) and how the variants drive disease pathology. The research involved using induced pluripotent stem cells derived from healthy donors and transforming them into macrophages. These were then exposed to 24 different stimuli mimicking infection and inflammation, and the gene expression profiles assessed six and 24 hours later, to see which genes were turned on or off in response. Macromap, the large scale dataset generated as a result, shows that many links are only manifest following disease-relevant stimulation, with bacterial or viral pathogens, or pro- or anti-inflammatory cytokines. The study has uncovered how genes behave during “more realistic immune response scenarios”, said Carl Anderson, head of the genomics of inflammatory and immunity group at the Sanger Institute, Cambridge University, U.K., co-author of the paper describing the research in Nature Communications, Aug 27, 2025.

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