05:13 AM EDT, 09/30/2026 (MT Newswires) -- Roche's (RO.SW) new drug application for fenebrutinib to treat relapsing and primary progressive multiple sclerosis received priority review status from the US Food and Drug Administration. The Swiss drugmaker said Wednesday that it supported the accepted application for the investigational non-covalent Bruton's tyrosine kinase, or BTK, inhibitor with data from a comprehensive clinical program that includes the phase 3 FENhance 1 and 2 studies in relapsing multiple sclerosis, alongside the phase 3 FENtrepid study in primary progressive multiple sclerosis. In the FENhance 1 and 2 trials, fenebrutinib significantly reduced relapses and both active and chronic brain lesions compared with teriflunomide, the standard of care. Meanwhile, in the FENtrepid study, the drug met its primary endpoint of working as well as Ocrevus, or ocrelizumab, the current standard of care and only approved medicine for primary progressive multiple sclerosis. Subject to the application's approval, fenebrutinib will become the first BTK inhibitor and first high-efficacy oral treatment for both types of multiple sclerosis in the US. "If approved, fenebrutinib could open a new chapter as the first high-efficacy oral therapy for both relapsing and primary progressive MS, helping to control disease activity while giving people more flexibility and choice," said Roche Pharmaceuticals Chief Executive Officer Teresa Graham. Shares of the company rose marginally at midday trading in Switzerland.

Disclaimer:This article represents the opinion of the author only. It does not represent the opinion of Webull, nor should it be viewed as an indication that Webull either agrees with or confirms the truthfulness or accuracy of the information. It should not be considered as investment advice from Webull or anyone else, nor should it be used as the basis of any investment decision.