Roche highlights fenebrutinib’s impact on chronic MS lesions ahead of FDA decision

Key points

• Fenebrutinib showed a 30% reduction in slowly expanding lesion volume and a 62% drop in paramagnetic rim lesions in relapsing MS.
• The drug demonstrated a 16% reduction in confirmed disability progression and a 23% decrease in annual brain volume loss.
• Roche CEO Teresa Graham predicts peak sales of 1 billion Swiss francs from primary progressive MS alone, exceeding analyst consensus.
• Berenberg maintains a Hold rating on Roche, citing strong growth from existing assets like Ocrevus and Hemlibra.

Background

Roche has been navigating a period of legacy medicine erosion, supported by strong growth from key assets such as Ocrevus, Hemlibra, and Vabysmo. The company recently received FDA priority review for Enspryng in MOGAD and supplemental approval for CNS autoimmune diseases. Fenebrutinib represents a next-generation BTK inhibitor intended to address chronic inflammation, a primary driver of disability in MS.

How outlets are covering it

Fierce Biotech emphasizes the clinical novelty of fenebrutinib’s effect on chronic active lesions, noting that Guggenheim Securities analysts view confirmed disability progression as a potential swing factor for the MS market. In contrast, MarketScreener highlights Berenberg’s cautious stance, maintaining a Hold rating with a target price of CHF 350, despite Roche’s bullish sales projections. While Fierce Biotech focuses on the drug’s potential to outperform anti-CD20 therapies, MarketScreener notes that Roche’s overall financial health is supported by existing blockbuster drugs, not solely fenebrutinib.

Why it matters

The FDA decision on fenebrutinib could reshape the treatment pathway for multiple sclerosis, potentially prioritizing BTK inhibitors over anti-CD20 drugs. Success in this area could drive significant revenue for Roche, while also addressing the unmet need for therapies that slow chronic brain inflammation and disability progression.

What to watch

The FDA is expected to make a decision on fenebrutinib in the coming months, with Roche targeting a launch next year. Berenberg anticipates the next major catalyst for Roche will be the FDA decision on giredestrant for breast cancer on November 30, followed by phase 3 data for afimkibart in colitis in early 2027.