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Investing.com -- Shares of Roche (SIX: RO, ROG; OTCQX: RHHBY (OTC:RHHBY)) declined by as much as 2.9% after the company announced that its Phase III MUSETTE trial of a higher dose of Ocrevus in relapsing multiple sclerosis (RMS) did not meet its primary endpoint. The study aimed to evaluate whether a higher dose of the currently approved Ocrevus IV 600 mg could provide additional benefits in slowing disability progression. However, the results indicated that the 600 mg dose remains the optimal treatment to slow disability progression in RMS patients.
The trial’s outcome was a setback for Roche, as the higher dose was anticipated to offer a new level of efficacy for RMS treatment. Despite the trial not meeting its primary endpoint, the high dose was well tolerated, with a safety profile comparable to the approved 600 mg dose and no new safety signals observed. These findings support the continued use of the Ocrevus IV 600 mg dose, which has become a standard of care in multiple sclerosis treatment and is the most prescribed disease-modifying therapy in the United States.
Genentech, a member of the Roche Group, emphasized that the MUSETTE trial’s data further corroborate the efficacy and safety of Ocrevus IV 600 mg for RMS. The treatment has seen widespread usage, with more than 400,000 people treated globally. Additionally, the company highlighted that Ocrevus is the first and only B-cell therapy approved for RMS and primary progressive multiple sclerosis (PPMS), with a significant majority of RMS patients remaining free from disease progression after more than ten years of treatment.
Roche also noted the recent launch of Ocrevus Zunovo™, aimed at improving the treatment experience for people living with multiple sclerosis, especially in centers without IV infrastructure or with limited IV capacity. The company’s pipeline includes a variety of formulations and targets, such as Brainshuttle™ CD20 and a monoacylglycerol lipase (MAGL) inhibitor in early development, as well as the Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib in Phase III studies for both RMS and PPMS.
The full data from the MUSETTE trial are expected to be presented at an upcoming medical meeting, which may provide further insights into the treatment’s performance and potential impact on Roche’s stock.
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