FDA accepts Genentech fenebrutinib NDA for relapsing, primary progressive multiple sclerosis under priority review

Bitget2026/09/30 05:06

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FDA accepted Genentech’s NDA for fenebrutinib for relapsing MS, priority review granted.
Filing also covers primary progressive MS, marking the first BTK inhibitor accepted for both MS forms.
Phase III FENhance trials cut relapse rates 51.1% to 58.5% versus teriflunomide over 96 weeks.
Phase III FENtrepid met non-inferiority to Ocrevus in PPMS disability progression, showing a 12% numerical risk reduction.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Genentech Inc. published the original content used to generate this news brief on September 29, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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FDA accepts Genentech fenebrutinib NDA for relapsing, primary progressive multiple sclerosis under priority review

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