Roche RHHBY announced that the FDA has accepted its supplemental application for Gazyva\/Gazyvaro (obinutuzumab) to treat systemic lupus erythematosus (SLE), based on strong phase III ALLEGORY study results.<\/p>\n
The trial showed significant improvement in disease activity at 52 weeks, with 76.7% of patients responding to treatment versus 53.5% on placebo.<\/p>\n
A regulatory decision is expected by December 2026. The drug is already approved for lupus nephritis in the United States and the EU.<\/p>\n
The study also showed benefits across secondary endpoints, including reduced flare risk, higher remission rates and improved low disease activity. Safety findings were consistent with the drug\u2019s known profile.<\/p>\n
Results were presented at SLEuro 2026 and published in the New England Journal of Medicine. Roche has also submitted the data to European regulators and continues to expand Gazyva\/Gazyvaro\u2019s use across immune-mediated diseases.<\/p>\n
Gazyva\/Gazyvaro\u2019s sales totaled CHF 986 million in 2025, up 14% year over year.<\/p>\n
RHHBY Reports Data on Enspryng <\/p>\n
Roche also reported positive phase III METEOROID results showing that Enspryng (satralizumab) reduced the risk of relapse by 68% in patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), meeting its primary endpoint. At 48 weeks, 87% of patients on Enspryng remained relapse-free versus 67% on placebo, with effects seen as early as eight weeks. Results were presented at the 2026 American Academy of Neurology (\u201cAAN\u201d) meeting.<\/p>\n
The drug also cut annual relapse rates by 66% and significantly reduced MRI lesions and the need for rescue treatments. These findings suggest Enspryng could become the first approved therapy for MOGAD, a rare and disabling autoimmune condition with no current approved treatments.<\/p>\n
Safety was consistent with prior data, with no new concerns identified. Roche plans to submit the data to global regulators.<\/p>\n
RHHBY Reports Data on Multiple Sclerosis Drug <\/p>\n
Roche also reported positive phase III FENhance 1 and 2 results at the 2026 AAN meeting.<\/p>\n
Data showed that fenebrutinib significantly reduced relapse rates in relapsing multiple sclerosis (RMS) versus teriflunomide. The drug cut annual relapse rates by 51% and 58.5%, respectively, over 96 weeks\u2014equating to roughly one relapse every 17 years results were presented at the<\/p>\n
Fenebrutinib also markedly reduced brain inflammation and lesion formation on MRI, with consistent benefits across patient groups, especially those with more active disease. Early signs of reduced disability progression were also observed.<\/p>\n
Safety was broadly comparable to teriflunomide, though a higher number of deaths was reported in the fenebrutinib group across studies. Overall findings from three phase III studies support its potential as a high-efficacy oral treatment for both relapsing and progressive MS, with regulatory submissions planned.<\/p>\n
The successful development of the candidate will boost Roche\u2019s neuroscience portfolio.<\/p>\n
Roche\u2019s Ocrevus is approved for RMS and relapsing-remitting MS. The drug is a top-growth driver for the company.<\/p>\n
RHHBY is developing more than a dozen therapies for neurology portfolios, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer\u2019s disease, Huntington\u2019s disease, Parkinson\u2019s disease and Duchenne muscular dystrophy.<\/p>\n
Novartis\u2019 NVS Kesimpta is indicated for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.<\/p>\n
Kesimpta has put up a strong performance since approval, boosting NVS\u2019 top line. The drug generated sales of $4.4 billion for Novartis in 2025.<\/p>\n
RHHBY\u2019s Efforts to Broaden Portfolio <\/p>\n
Strong growth from key products is helping RHHBY offset revenues from legacy drugs.<\/p>\n
Roche\u2019s shares have lost 3% year to date compared with the industry\u2019s 5.5% loss.<\/p>\n
Zacks Investment Research <\/p>\n
Image Source: Zacks Investment Research<\/p>\n
The MS drug Ocrevus and the ophthalmology drug Vabysmo continue their stellar performances. Growth in hemophilia treatment Hemlibra and breast cancer drug Phesgo has also boosted RHHBY\u2019s top line.<\/p>\n
Vabysmo has given stiff competition to Regeneron\u2019s REGN ophthalmology drug Eylea. Positive data from additional studies bode well for the drug.<\/p>\n
Regeneron co-developed Eylea with Bayer.<\/p>\n
Roche has a strong and diversified pipeline spanning multiple therapeutic modalities. Approval of additional drugs will further boost pipeline growth.<\/p>\n
RHHBY\u2019s Zacks Rank and Stock to Consider <\/p>\n
Roche currently carries a Zacks Rank #3 (Hold).\u00a0 A better-ranked biotech company is ADMA Biologics ADMA, which currently has a Zacks Rank #2 (Buy).\u00a0 You can see the complete list of today\u2019s Zacks #1 Rank (Strong Buy) stocks here.<\/p>\n
Over the past 60 days, estimates for ADMA Biologics\u2019 2026 EPS have increased from 85 cents to 93 cents. ADMA shares have plummeted 40.5% year to date.<\/p>\n
ADMA Biologics\u2019 earnings beat estimates in one of the trailing three quarters, matched once and missed in the other, the average negative surprise being 1.79%.<\/p>\n
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report<\/a><\/p>\n Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report<\/a><\/p>\n Novartis AG (NVS) : Free Stock Analysis Report<\/a><\/p>\n Roche Holding AG (RHHBY) : Free Stock Analysis Report<\/a><\/p>\n ADMA Biologics Inc (ADMA) : Free Stock Analysis Report<\/a><\/p>\n This article originally published on Zacks Investment Research (zacks.com).<\/a><\/p>\n