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Roche's (RHHBY) MS Drug Meets Goals in the Phase II Study

Roche RHHBY announced that the mid-study evaluating investigational oral fenebrutinib in adults with relapsing forms of multiple sclerosis (RMS) was successful.

Fenebrutinib is an investigational, potent and highly selective oral Bruton’s tyrosine kinase inhibitor. Phase II FENopta is a randomized, double-blind, placebo-controlled 12-week study to investigate the efficacy, safety and pharmacokinetics of fenebrutinib in 109 adults aged 18-55 years with RMS.

The study met its primary and secondary endpoints by reducing the total number of new gadolinium-enhancing T1 brain lesions and significantly reducing the total number of new or enlarging T2 brain lesions compared to placebo.

T1 lesions, as measured by magnetic resonance imaging, are a marker of active inflammation. Meanwhile, T2 lesions represent the amount of disease burden or lesion load.


In addition, a higher proportion of patients treated with fenebrutinib were free from any new gadolinium-enhancing T1 brain lesions and new or enlarging T2-weighted brain lesions compared to placebo.

The approval of fenebrutinib will strengthen Roche’s multiple sclerosis (MS) franchise, which includes Ocrevus. Moreover, the phase III fenebrutinib clinical trial program in RMS and primary progressive MS is ongoing.

Roche’s stock has risen 0.4% so far in the year compared with the industry’s growth of 2.4%.

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Roche’s performance in the first quarter was ordinary as significantly lower COVID-19 product sales impacted the top line, though new drugs — Ocrevus, Hemlibra, Evrysdi and Tecentriq — recorded growth, and the uptake of the new eye drug, Vabysmo (launched at the beginning of 2022), was outstanding.

Sales are likely to be impacted further due to the expected sharp decline in sales of COVID-19 products of roughly CHF 5 billion in 2023. Competition from biosimilars for established cancer medicines like Avastin, MabThera/Rituxan and Herceptin also harmed sales.

Zacks Rank & Other Stocks to Consider

Roche currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the healthcare sector are Novo Nordisk NVO and Novartis NVS. Novo Nordisk currently sports a Zacks Rank #1 (Strong Buy), and Novartis carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 30 days, estimates for NVO’s 2023 earnings have risen by 23 cents to $4.95. Novo Nordisk topped earnings estimates in three of the last four quarters and missed the same in the remaining one, the four-quarter earnings surprise being 0.35%, on average.

Over the past 30 days, earnings estimates for NVS have increased to $6.67 from $6.57 for 2023. Novartis also surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.

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