immunology
Safety questions loom over Roche's MS drug
Roche's investigational multiple sclerosis drug has now been shown to be effective in three late-stage trials, but it's not clear whether regulators will approve the treatment, called fenebrutinib.
Analysts have highlighted some potentially worrying liver safety signals, an issue that previously led the FDA to reject an MS therapy developed by Sanofi. In data released yesterday, researchers also disclosed there were two drug-related deaths among patients who took the therapy.
An approval would help Roche offset some of the revenue loss that’s expected when its current best-selling medicine, an MS treatment called Ocrevus, starts to lose exclusivity protections in 2029.
Read more from STAT's Drew Joseph.
biotech
CAR-T for autoimmune disease faces regulatory test
CAR-T treatments are currently only approved for blood cancers, but more biotechs are pivoting their programs to study CAR-T therapies in autoimmune diseases. The first such treatment may soon be on the market.
Kyverna Therapeutics reported yesterday that its one-time, personalized cell therapy improved mobility and reduced disabilities in patients with stiff person syndrome, a rare, neurological autoimmune disorder.
With those results, the biotech plans to submit the treatment to regulators this year.
Read more from STAT's Adam Feuerstein.