Arcus Biosciences Inc. provided an update on the phase III Star-221 study conducted in partnership with Gilead Sciences Inc., saying the trial will stop due to futility. Star-221 was designed to test the anti-TIGIT antibody domvanalimab plus the Arcus anti-PD-1 antibody zimberelimab and chemotherapy vs. Opdivo (nivolumab, Bristol Myers Squibb Co.) plus chemo as a first-line treatment for advanced gastric and esophageal cancers. At the interim analysis, the domvanalimab-based pairing did not improve overall survival relative to the Opdivo/chemo regimen. Shares of Hayward, Calif.-based Arcus (NASDAQ:RCUS) were trading at $23.66, down $1.48. The company said future work will focus on such pipeline prospects as the hypoxia-inducible factor 2 alpha inhibitor casdatifan, which has shown robust single-agent activity in more than 120 patients with late-line clear cell renal cell carcinoma in the Arc-20 phase I/Ib study.

CHMP recommends Immunitybio's Anktiva, Cytokinetics' Myqorzo

The EMA is joining the U.S. FDA and the U.K. Medicines and Healthcare products Regulatory Agency in approving Anktiva (nogapendekin alfa inbakicept-pmin) in patients with non-muscle invasive bladder cancer (NMIBC) who have not responded to immune stimulation treatment with Bacillus Calmette-Guérin (BCG) vaccine and would otherwise require surgical removal of the bladder. There are currently no authorized treatments for NMIBC when it does not respond to BCG. Cytokinetics Inc. also gained the EMA’s recommendation to approve Myqorzo (aficamten) to treat adults with obstructive hypertrophic cardiomyopathy. Myqorzo has a Dec. 26 PDUFA date in the U.S.

Menarini sees Asia Pacific as growth engine for its global future

Experience gained in the Asia-Pacific region is helping shape the Menarini Group’s global strategy as the Italian pharmaceutical company looks to emerging markets to drive long-term, sustainable growth. Asia Pacific’s deep diversity, agility, collaborative culture and inherent market fragmentation have become core strategic lessons that the company is now applying not only across other emerging markets but even in mature Western markets, Maurizio Luongo, global commercial leader of Menarini’s pharma division, told BioWorld. Luongo joined Menarini in 2010 to build the consumer health business, with a mandate to shape it into a global operation.

Cycle buying Applied Therapeutics to develop CNS drug

Cycle Group Holdings Ltd. is buying Applied Therapeutics Inc. for a small fraction of the company’s value when it went public in 2019. Cycle is paying $0.088, nearly 9 cents, in cash per share plus a contingent value right. Cycle will receive Applied’s lead candidate govorestat, a CNS penetrant aldose reductase inhibitor for rare metabolic diseases such as classic galactosemia, Charcot-Marie-Tooth sorbitol dehydrogenase deficiency and phosphomannomutase 2 congenital disorder of glycosylation. In May 2019, Applied Therapeutics priced its IPO, offering 4 million shares at $10 apiece, below its previously disclosed range of $14 to $16. Gross proceeds were about $40 million. Applied’s shares (NASDAQ:APLT) were down 45% at midday, trading at 12 cents each.

Research unpicks molecular mechanism of vaccine-induced cardiac inflammation

The cardiomyositis that is a rare adverse effect of mRNA-based COVID vaccines is due to immune cell activity as a result of increased levels of the chemokines CXCL10 and interferon-γ (IFN-γ). Blocking CXCL10 and IFN-γ could prevent muscle cell damage in cell culture, and cardiomyositis in animal models. After vaccination with an mRNA vaccine, “macrophages come by and they kind of sniff … out [the mRNA] and pump out CXCL10,” Joseph Wu told BioWorld. The CXCL10 attracts and primes T cells, which release IFN-γ, “which attracts more macrophages. And then it becomes a cycle.” The findings, reported in the Dec. 10, 2025, issue of Science Translational Medicine, suggest a way of mitigating the risk of cardiomyositis that is a possible side effect of mRNA vaccines. Wu is the director of the Stanford Cardiovascular Center, past president of the American Heart Association, and the study’s co-corresponding author.

The BioWorld Insider podcast: Finding a better, longer-lasting fix in opioid overdose

The opioid crisis may not be front and center anymore, but it’s raging still. A major problem is that overdose-reversal drugs don’t last long enough to help users who opt out of hospital treatment after they are revived. Elysium Therapeutics Inc. CEO Greg Sturmer talks with Randy Osborne about his firm’s candidate for a solution to the medical and societal problem. The NIH – which has been helpful to Elysium since the company’s founding – the FDA, and others are working to advance a longer-lasting reversal agent. Experiments already done with approved reversers, as well as computer modeling that’s been used by regulators previously, will help in the push, Sturmer said.

Also in the news

Alphyn, Avenzo Therapeutics, Bbot, Beyondspring, Carric Therapeutics, Contineum Therapeutics, Corbus Pharmaceuticals, Cosette, Dyne Therapeutics, Elicio Therapeutics, Enveric Biosciences, Everest Medicines, Genfit, Genmab, Geron, GRI Bio, Hyloris, Idorsia, Immatics, Immunewalk Therapeutics, Karolinska, Lir Life Sciences, Novabridge, OKYO Pharma, Oruka Therapeutics, Rhythm Pharmaceuticals, Serina Therapeutics, Starton Holdings, Structure Therapeutics, SVF Vaccines, Tenaya Therapeutics, Terns, Tetraneuron, Valneva, Zegenex