Novartis' Remibrutinib Delivers Positive Results in Late-Stage MS Studies

Novartis NVS announced positive top-line results from the late-stage REMODEL-1/-2 studies on remibrutinib in relapsing multiple sclerosis (RMS).

Remibrutinib is a highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor that blocks the BTK pathway, reducing the activation of B cells and innate immune cells to modulate immune regulatory networks and associated neuroinflammation.

REMODEL-1 and REMODEL-2 are identical multicenter, randomized, double-blind, active comparator-controlled phase III studies evaluating the efficacy and safety of remibrutinib compared to Aubagio (teriflunomide) in adults with RMS.

The studies met their primary endpoint, significantly reducing annualized relapse rate (ARR) versus Aubagio in the targeted patient population.

Shares of the company gained 6% following the results. Year to date, Novartis shares have gained 17% compared with the industry’s growth of 13%.

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More on NVS’ RMS Studies

In the REMODEL-1 and REMODEL-2 studies, approximately 2,000 patients worldwide with recent evidence of disease activity and an Expanded Disability Status Scale (EDSS) score of 0.0-5.5 were randomized equally to receive either remibrutinib 100 mg or Aubagio.

The studies comprise an initial double-blind Core Part lasting up to 30 months, followed by an open-label extension of up to five years.

Remibrutinib demonstrated superiority versus Aubagio in reducing ARR (primary endpoint) and inflammatory brain lesions with a favorable safety profile.

The results of the REMODEL studies establish remibrutinib as a BTK inhibitor that achieved significant reductions in ARR across two late-stage studies in RMS adult patients.

Remibrutinib also showed clinically meaningful reductions versus Aubagio in key secondary endpoints related to disability progression, with a positive trend in 3-month confirmed disability progression and nominal significance in 6-month confirmed disability progression in a preplanned combined analysis of REMODEL-1/-2 studies.

Remibrutinib demonstrated a favorable safety profile with no liver safety signal, consistent with the drug’s safety profile in the chronic spontaneous urticaria (CSU) indication.

Novartis plans to present data from the REMODEL-1 and REMODEL-2 studies as a late-breaking presentation at MSToronto2026, followed by an investor call after the congress. The company also intends to pursue regulatory approvals for remibrutinib in RMS across global markets.

We remind investors that remibrutinib 25 mg was approved as Rhapsido by the FDA in September 2025 and the EMA in April 2026 for the treatment of adults with CSU.

Rhapsido generated sales of $101 million in the first half of 2026. The drug continues to see strong early uptake in the United States, aided by expanding payer coverage and a free-drug program that is helping improve patient access. Outside the United States, sales benefited from early-launch momentum in China, while recent launches in Germany, Austria and the UAE, following second-quarter approvals, also contributed to growth in CSU.

A potential label expansion into additional indication should boost sales.

Remibrutinib is also being investigated in the REMASTER study in secondary progressive multiple sclerosis, as well as other immune-mediated conditions, such as hidradenitis suppurativa and food allergy.

Novartis’ broad and strong portfolio already includes RMS drug Kesimpta (ofatumumab). The drug is an anti-CD20 monoclonal antibody that enables the targeted depletion of B-cells, specifically in lymph nodes. Kesimpta is approved in the United States to treat adults with RMS, including clinically isolated syndrome, relapsing-remitting multiple sclerosis and active secondary progressive multiple sclerosis.

Novartis Looks to Strengthen Portfolio

Novartis delivered a strong second-quarter performance, demonstrating that its portfolio of newer growth products is increasingly capable of offsetting the impact of generic competition, including the loss of U.S. exclusivity for blockbuster heart failure drug Entresto.

Strong demand for key growth brands, including Kisqali, Kesimpta, Scemblix, Pluvicto and Leqvio, is boosting the top line.

With 2026 marking the largest patent cliff in the company's history, execution remains the key investment theme.

Novartis is also strengthening its long-term growth outlook through targeted business development.

Separately, per a Wall Street Journal article, NVS recently paused eight clinical studies on experimental CAR-T cell treatment, rap-cel, after three patients died.

NVS’ Zacks Rank & Stocks to Consider

Novartis currently carries a Zacks Rank #3 (Hold).  A couple of better-ranked stocks in the drug/biotech sector are Repligen RGEN and Anika Therapeutics ANIK, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while those for 2027 EPS have increased from $2.57 to $2.61 during the same period. RGEN’s shares have gained 3.8% year to date.

Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.

Over the past 60 days, estimates for Anika Therapeutics’ 2026 EPS have risen from 41 cents to $1.05, while those for 2027 EPS have increased from 46 cents to 95 cents over the same period. ANIK’s shares have surged 119.7% year to date.

 

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