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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.
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.
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.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
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.