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Journal / Remibrutinib completes Phase III: Brederode gains a growth option at Novartis

Analysis · Brederode S.A.

Remibrutinib completes Phase III: Brederode gains a growth option at Novartis

Two positive trials in multiple sclerosis add depth to the 7.1% of the listed portfolio invested in Novartis. The results are promising; however, the commercial value remains to be built.

Courtesy translation of the French original.

A neuroscience lab with brain imaging and a long-term investment plan
Editorial illustration generated for Opulion - it does not necessarily depict a real place or event.

To understand why a Novartis clinical release warrants analysis on Brederode, we must start with the portfolio. As of March 31, 2026, Novartis was the holding company's largest listed healthcare holding: 819,200 shares, valued at €107.69 million. The holding represented 7.1% of the listed portfolio and approximately 2.6% of Brederode's equity. Remibrutinib is therefore not an abstract drug on a list of projects: it is a growth option within an identifiable and already contributing stake.

The essentials

The Phase III REMODEL-1 and REMODEL-2 trials met their primary endpoint: remibrutinib significantly reduced the annualized relapse rate compared to teriflunomide in adults with relapsing multiple sclerosis. Novartis also announced superiority in key secondary endpoints, a favorable trend in disability progression, and the absence of liver signaling. However, detailed data have not yet been published: no specific relapse reduction figures are provided in the press release.

Why this news matters for Brederode

Brederode views Novartis as a large, high-quality listed asset, not as a small, speculative biotech holding. A Phase III success can bolster the pharmaceutical group's future growth engine and diversify its neuroscience franchise. But the transmission to Brederode is indirect: clinical trial results, regulatory filing, approval, reimbursement, medical adoption, and sales must all follow one another before any economic value appears in the results.

Novartis' weighting in Brederode's listed portfolio as of March 31, 2026.
7,1 %
Patients randomized in the two REMODEL Phase III trials.
≈2 000
Two independent studies that met their primary endpoint.
2 essais

A clinical result that closes the door on chance.

A positive trial can always be an isolated pleasant surprise. Two identically designed trials, conducted internationally and both meeting the same primary endpoint, reduce this risk. REMODEL-1 and REMODEL-2 compared remibrutinib with teriflunomide in adults with relapsing multiple sclerosis. Participants were equally allocated to the two treatments. The controlled phase could last up to 30 months, followed by an open-label extension of up to five years.

The primary endpoint was the annualized relapse rate. Novartis says it achieved a statistically significant reduction compared to the comparator in each of the two studies. The company also claims superiority on all key secondary endpoints in each trial, including lesions seen on brain imaging. In a pre-planned pooled analysis, a positive trend was observed in confirmed disability progression at three months and a nominally significant result at six months.

Word choice matters. “Nominally significant” does not necessarily mean that the result meets all the planned statistical corrections for testing multiple endpoints. And “positive trend” is not proof. Without absolute values, confidence intervals, discontinuation rates, and subgroup analyses, the clinical magnitude of the benefit cannot be measured. Novartis plans to present the detailed data at the MSToronto2026 congress before seeking approval from health authorities.

Opulion Reading

Why the BTK class is so intriguing

Remibrutinib inhibits Bruton's tyrosine kinase, or BTK, a protein involved in the activation of B cells and innate immune cells. In multiple sclerosis, the aim is to modulate several components of inflammation, including those that may contribute to neuroinflammation, with an oral treatment. The promise is attractive: to combine efficacy, ease of administration, and a favorable tolerability profile.

This promise is not automatically shared by the entire class. Several BTK programs have encountered difficulties with safety, efficacy, or timing. Novartis therefore emphasizes the selectivity of its molecule and the absence of liver signaling in REMODEL. More than 4,500 participants received remibrutinib in its development program across several indications, depending on the group. No cases meeting the so-called "Hy's Law" criteria, used to identify certain serious risks of drug-induced liver injury, were observed in these two trials.

One element also distinguishes remibrutinib from an entirely new drug: the molecule is already marketed under the name Rhapsido for chronic spontaneous urticaria, following approval in the US in September 2025 and in Europe in April 2026. This does not prejudge its approval in neurology, where the dose, patient population, and benefit-risk ratio are specific. However, Novartis already has industrial, regulatory, and medical experience with the molecule.

The educational visual: six steps before value creation

A Portfolio Option, Not a Complete Thesis

The Novartis stock had already held up well during a difficult first quarter for Brederode. The holding company reported an indicative performance of 14.7% for this investment, including net dividends, compared to a 2.7% decline for the entire listed portfolio. This snapshot explains why a credible pipeline extension is important: it reinforces one of the few positive contributions at a time when uncertainties related to AI and the geopolitical context were weighing on other assets.

However, it's important to keep things in perspective. Novartis represents approximately 2.6% of Brederode's equity based on the values ​​published as of March 31; remibrutinib is only one component of Novartis. Even a major commercial success would therefore only partially benefit the holding company. The significance of this news lies less in its immediate impact on net assets than in what it reveals: the holding company has a new and credible avenue for renewing its drug portfolio.

This is precisely one of the functions of a diversified holding company. Brederode's shareholder is not choosing remibrutinib in isolation. It owns a portfolio where Novartis' clinical risks coexist with the recurring cash flows of Iberdrola and Enel, the franchises of Mastercard and Unilever, Alphabet's technology option, and a broad portfolio of private equity funds. Diversification does not render the clinical trial insignificant; it puts it into proper perspective.

Strength

What the press release establishes

Clinical validation

Two phase III trials met their primary endpoint with a safety profile described as favorable. Remibrutinib therefore has a credible path to broaden Novartis's growth engine.

Limitation

What it does not establish

Commercial value

Full data, approval, reimbursement, market share and sales are still ahead. Even a major success would only partly flow through to Brederode, where Novartis is one component of a diversified portfolio.

The intriguing aspect: a single asset, multiple markets

Remibrutinib illustrates an important mechanism in the pharmaceutical industry: a single molecule can become a platform for several indications. In addition to chronic spontaneous urticaria and relapsing-remitting multiple sclerosis, Novartis is studying it in secondary progressive multiple sclerosis, hidradenitis suppurativa, and food allergy. Each indication requires its own evidence and can fail independently. But reusing a scientific and industrial base increases the number of possible paths to value creation.

For the Brederode investor, the next exciting step will therefore not be another superlative in a press release. It will be the curves: how many relapses were prevented, what was the progression of disability, how many treatment discontinued, what were the adverse effects, and how consistent was the two trials? It is at this point that we can distinguish between a product that is merely acceptable and one that has the potential to truly change medical practices.

To be monitored

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