Roche's Higher Dose of Ocrevus Fails to Meet Goal in RMS Study

Swiss pharma giant Roche RHHBY faced a setback in its efforts to develop a higher dose of multiple sclerosis drug Ocrevus (ocrelizumab).

The company announced that a phase III study, MUSETTE, which compared a higher dose of Ocrevus intravenous (IV) infusion to the currently approved Ocrevus IV 600 mg dose in patients suffering from relapsing multiple sclerosis (RMS), did not meet its primary endpoint.

The higher dose of the drug did not show additional benefit in slowing disability progression, as measured by a composite disability endpoint over at least 120 weeks of treatment.

Shares of Roche have risen 15.2% year to date compared with the industry’s 1.6% growth.

More on RHHBY’s Ocrevus

Multiple sclerosis, a chronic disease, occurs when the immune system abnormally attacks the insulation and support surrounding nerve cells in the central nervous system (including the brain, spinal cord, and optic nerves), causing inflammation and subsequent damage.

Per Roche, Ocrevus IV and Ocrevus subcutaneous (marketed as Ocrevus Zunovo in the United States) are the only therapies approved for both RMS and primary progressive multiple sclerosis (PPMS). Both the formulations are administered every six months. The initial IV dose is administered as two 300 mg infusions, two weeks apart, with subsequent doses given as single 600 mg infusions. Ocrevus SC is given as a single 920 mg subcutaneous injection every six months.

MUSETTE trial was designed to determine whether a higher dose of the currently approved Ocrevus IV 600 mg would provide additional benefit to RMS patients.

However, results support Ocrevus IV 600 mg as the optimal dose to slow disability progression.

Nonetheless, the higher dose was well tolerated, with an overall safety profile compared to that of the approved dose.

RHHBY’s Efforts to Boost Portfolio

Ocrevus was one of the top four growth drivers for RHHBY in 2024. Sales of the drug totaled $6.7 billion in 2024, up 9% year over year.

In addition to Ocrevus, Roche has a diverse pipeline of formulations and targets, including candidates such as Brainshuttle CD20 and a monoacylglycerol lipase (MAGL) inhibitor. It is also evaluating Bruton’s tyrosine kinase (BTK) inhibitor, fenebrutinib, in phase III studies for both RMS and PPMS.

Roche’s performance in 2024 was good as high demand for key drugs offset the decline in sales of legacy drugs. Ophthalmology drug Vabysmo continued its stellar performance. The drug posed stiff competition to Regeneron’s REGN ophthalmology drug Eylea. Positive data from additional studies bode well for the drug.

Regeneron co-developed Eylea with Bayer.

Growth in hemophilia treatment Hemlibra also boosted the top line.

The company launched two new drugs in 2024 — Itovebi for a hard-to-treat breast cancer and PiaSky for a serious blood disorder.

The company recently obtained FDA approval for TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke in adults.

However, pipeline setbacks weigh on the stock. Roche also expects the loss of exclusivity for key drugs to negatively impact sales by CHF 1.2 billion in 2025.

Roche expects total sales to grow in the mid-single-digit range (at CER) in 2025. Core earnings per share are expected to grow in the high single-digit range. Roche expects to increase its dividend in Swiss francs further.

RHHBY’s Zacks Rank and Stocks to Consider

Roche currently carries a Zacks Rank #3 (Hold).

A couple of better-ranked stocks in the pharma/biotech sector are Bayer BAYRY and Gilead Sciences GILD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Bayer

In the past 30 days, Bayer’s earnings per share (EPS) estimate for 2025 has increased to $1.19 from $1.14. During the same timeframe, the figure for 2026 has increased to $1.28 from $1.23. Shares of BAYRY have surged 33.8% in the past three months.

Gilead Sciences

In the past 60 days, Gilead Sciences’ EPS estimate for 2025 has increased from $7.55 to $7.87. During the same timeframe, the figure for 2026 has increased to $8.31 from $8.17. Shares of GILD have surged 20% year to date.

GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.

 

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