Phase 2
The disclosure—which came ahead of a presentation of data from the Phase 1 Breakfree-2 study at the ACTRIMS-ECTRIMS meeting—follows Bristol Myers Squibb’s late summer revelation that it had paused certain trials of zolacabtagene autoleucel.
A combination of Tango Therapeutics’ vopimetostat and Revolution Medicines’ recently approved Rasonque led to a response rate of 82% in an ongoing Phase 1/2 trial—a drop from 92% that was reported in June in fewer patients.
After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aardvark plans to resume testing the candidate next year.
Rapport Therapeutics clocked its second Phase 2 win in 14 months for RAP-219—which the company is positioning as a potential pipeline-in-a-product—this time showing improvement in symptoms of bipolar mania.
Gilead’s emvistegrast delivered greater clinical response than placebo, setting up the asset for Phase 3 testing in ulcerative colitis as well as studies in other inflammatory diseases and bolstering the company’s push beyond its HIV portfolio.
AbbVie’s next-gen dual-targeting therapy elicited higher rates of remission than its IL-23 inhibitor Skyrizi in a Phase 2a trial of Crohn’s disease, leading analysts to wonder if the blockbuster can be outdone.
Novartis will continue to study Fabhalta in other indications, with late-stage studies in two rare diseases—atypical haemolytic uraemic syndrome and generalized myasthenia gravis—expected to read out later this year and next year, respectively.
Arrowhead Pharmaceuticals’ siRNA candidate achieved “compelling” tau reductions in an early study of healthy volunteers, with a magnitude of effect that seems to outperformother blood-brain barrier platforms, according to Stifel.
Revolution Medicines’ recently approved drug showed a 24% overall response rate and a high rate of side effects in patients whose cancer has a G12D mutation, reinforcing Mizuho’s view that a more specific agent such as Verastem Oncology’s VS-7375 “should come first for G12D patients.”
Syndax Pharmaceuticals will no longer test Niktimvo for idiopathic pulmonary fibrosis, but the company’s work to expand the drug’s label in chronic graft-versus-host disease, for which it was approved in 2024, will continue.
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