News

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.
FEATURED STORIES
At the European Society for Medical Oncology meeting this weekend, Merck will showcase three late-stage trials of its Kelun-Biotech–partnered TROP2-directed antibody sac-TMT that VP of Chemistry Alan Northrup says gets the payload release “just right.”
A strong crossover raise can suggest that a company has “reached a level of maturity” and could go public soon, according to Sofinnova Investments’ Jim Healy.
China may be taking the majority of licensing deals this year but those transactions don’t tell the whole story, according to Locust Walk, which points to the spike in M&A among U.S. biotechs as leveling the playing field.
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Watching the baseball playoffs this week, I was struck by the parallels between the Los Angeles Dodgers and Eli Lilly. Both franchises spend a lot of money and always appear to come out on top.
THE LATEST
Invikafusp alfa, a first-in-class dual T cell agonist, showed an objective response in various types of cancer, particularly among patients who did not respond to previous checkpoint inhibitor therapy.
A new proposal from the U.S. government seeking to address investment in Chinese biotech as a matter of national security drew cautious statements from across the industry, with leaders vowing to ensure innovation isn’t stifled.
FDA
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.
Roche will pay Zymeworks $55 million upfront plus another $40 million once the partnership asset enters Phase 1b development and up to $718 million in additional milestones.
A combination of the personalized cancer vaccine intismeran autogene and Merck’s Keytruda just barely cleared analysts’ expectations for recurrence-free survival, leaving questions as to its applicability to tumor types beyond melanoma.
AbbVie is eyeing regulatory filings in 2027 for the skin disease drug lutikizumab after clearing multiple endpoints in a late-stage trial, but the results have disappointed some analysts, raising questions about its commercial prospects.
FDA
Troriluzole, in development for spinocerebellar ataxia, was rejected nearly a year ago when the FDA took issue with the design of Biohaven’s registrational study. The agency has now agreed to review a new application and render a decision in the first quarter of 2027.
IPO
The sector’s IPO tally has surpassed each of the past four years, with four October debuts adding momentum—but activity still remains well below the COVID-19 boom that saw nearly 100 public debuts in 2021.
The approval of Hibsago has created a new market for a handful of biopharmas, including Gilead, Arrowhead, and Vir, to fill in.
Aside from RG6540, Roche also discontinued a host of other early-stage assets, including an antisense oligonucleotide for Alzheimer’s disease and a small-molecule candidate for geographic atrophy.