Has Novartis stopped ALL research programs on rapcabtagene autoleucel?

No. Novartis discontinued rap-cel studies in immunology and neuroscience due to three deaths from hemodialysis syndrome. However, the program on rap-cel in oncology is not affected by the suspension and continues as normal. The decision to isolate between the two areas was taken to manage the clinical risks in a precautionary manner.

What is the hemodialytic syndrome Novartis talks about?

According to Novartis, it is a rare complication associated with immune effector cells in the context of CAR-T therapies such as rap-cel. The three reported cases had fatal outcomes, leading the pharmaceutical company to suspend studies to more closely evaluate the safety data. It is an already known risk for this type of therapeutic approach.

What is Remibrutinib and when will it be available for multiple sclerosis?

Remibrutinib is an oral drug that selectively inhibits an enzyme involved in immune cell activation. It showed positive results in the Remodel-1 and Remodel-2 studies for relapsing multiple sclerosis (approximately 2,000 patients globally). Novartis will present the full data at the MStoronto2026 congress in Canada, then seek authorisation from global regulatory authorities. It is already approved in the US and Europe under the name Rhapsido for chronic spontaneous urticaria.

Why did the Novartis stock go up 5% despite the suspension?

The market globally evaluated the two announcements: the precautionary suspension of some trials was offset by the very positive results of Remibrutinib. Since the beginning of the year, the stock has gained 19% and is among the twenty main values of the SMI, reflecting the confidence of investors in the solidity of the company's pipeline.

Bristol-Myers-Squibb has suspended similar studies, is this a precedent?

Yes. US competitor Bristol-Myers-Squibb had previously suspended similar studies as a precaution. This indicates that the risks of CAR-T therapies are already known in the global pharmaceutical industry and that precautionary suspensions are part of the ordinary process of managing clinical research when safety signals emerge.

Novartis suspends clinical trials, +5% on the stock market

Di Redazione Frontaliere Ticino · Published on 1 September 2026

Swiss pharmaceutical laboratory with researchers analyzing data on screens in modern research facility.

Novartis has stopped studies on rap-cel due to three deaths; at the same time it announces positive results on Remibrutinib. Stock +5% today, +19% YTD.

Context

In brief

Novartis discontinues studies on rap-cel, 3 deaths from hemodialysis syndrome
Positive results for Remibrutinib in multiple sclerosis (2,000 patients)
Action gains +5%, +19% year-to-date

Key Facts

What: Suspension of clinical trials of rapcabtagene autoleucel (rap-cel)
When: End of August 2026
Who: Swiss pharmaceutical giant Novartis
Cause: Three deaths from hemodialysis syndrome
Amount: Stock +5% today, +19% YTD, +27% over 12 months

Novartis halted several clinical trials of experimental cell treatments against autoimmune diseases in the fields of immunology and neuroscience at the end of August. The Swiss company confirmed the news following the deaths of three patients involved in these research programs, ATS told the news agency.

The cause of the suspension is the notification of three cases of hemodialylic syndromes associated with immune effector cells, the complications of which have had fatal outcomes. The experimental treatment, called rapcabtagene autoleucel (or rap-cel), is based on a cell therapy known as CAR-T, which genetically modifies a patient's white blood cells to induce them to destroy defective cells.

Death due to an immune reaction is a known risk for this type of therapeutic approach. US competitor Bristol-Myers-Squibb had previously suspended similar studies as a precautionary measure, confirming that the risks associated with CAR-T therapies fall within the routine management of clinical research.

However, Novartis was keen to emphasize that the program on rap-cel in oncology is absolutely not affected by the suspension, thus maintaining the continuity of studies in the oncology field.

Concurrently: Positive results on Remibrutinib

On the same day, Novartis announced positive results from two phase III clinical trials, called Remodel-1 and Remodel-2, which evaluated the effectiveness of the active ingredient Remibrutinib in relapsing multiple sclerosis. The studies involved approximately 2,000 patients worldwide.

Remibrutinib demonstrated a significant reduction in the annual relapse rate compared to the comparator drug Teriflunomide. It is an oral drug that selectively inhibits an enzyme involved in the activation of immune cells. Novartis plans to present the full data at the MStoronto2026 scientific congress in Canada, and then initiate marketing authorization procedures with the global regulatory authorities.

Remibrutinib has already gained approval in the United States and Europe under the trade name Rhapsido for the treatment of chronic spontaneous urticaria, a skin disease characterized by recurrent itching and the appearance of wheals.

Market reaction

The news was well received on the stock market: Novartis shares gained about 5% in today's session. Since the beginning of the year, the stock has gained 19%, while the performance over longer periods has been largely positive: +27% over twelve months and +63% over five years.

Novartis is one of the twenty largest stocks on the SMI, the index of the most important stocks on the Swiss Stock Exchange. The performance of the stock directly influences the capital gains of those who hold direct shares, which is relevant at the dichiarazione delle imposte level and for many Swiss investor portfolios.

Operational details

Risk management in advanced therapies

CAR-T therapies represent an innovative but complex approach in the treatment of autoimmune and oncological diseases. Hemodialysis syndrome, of which Novartis has reported three fatal cases, is a rare but known complication of these therapies. It is therefore not a completely unexpected event, but rather a risk managed through precautionary withdrawal protocols when the number of adverse events exceeds certain tolerability thresholds.

The fact that Bristol-Myers-Squibb has previously adopted the same suspension strategy indicates that the global pharmaceutical industry is taking these risks into account as part of the regulatory development process. Novartis' decision to maintain studies in oncology, while suspending those in immunology and neuroscience, suggests a differentiated assessment of benefits and risks depending on the target pathology.

Implications for Swiss investors

For those who own Novartis shares within a Swiss portfolio, or for those who invest through conti bancari that include the stock, the latest news reflects a mixed dynamic. The suspension of some studies represents a temporary drag in the pipeline, but the positive results of Remibrutinib offset this loss of momentum. This balance is evident from the stock's 5% rise despite the bad news about the suspension: the market is viewing the announcements overall as net progress thanks to the strength of the Remibrutinib data.

Novartis' position as one of the twenty main values of the SMI means that changes in its stock directly affect the performance of the national index. For Swiss savers with exposure to the local stock market (via ETFs on the SMI, pension funds with a Swiss equity component, or direct investments), this volatility is a daily reality that requires monitoring.

Swiss pharmaceutical innovation

Novartis remains one of the most important companies for the Swiss economy, not only as a market force but also as an R&D center. The company's ability to manage complex clinical trials, suspend studies when necessary, and advance promising pipelines (such as Remibrutinib) reflects the robustness of the Swiss pharmaceutical industry. The presentation of the data at the MStoronto2026 congress and the subsequent application for authorization from global regulatory authorities underscore how Novartis operates in a global context, but R&D decisions remain strongly rooted in Switzerland.

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Key points

What to monitor as an investor

If you hold Novartis shares or funds that include the stock, it is important to follow future developments on Remibrutinib. The presentation of data at the MStoronto2026 conference will be a critical moment to assess whether the positive results of the Remodel-1 and Remodel-2 studies will continue to find favor with global regulatory authorities. Approvals in the USA and Europe could significantly influence the stock price in the coming months.

Similarly, the resumption of suspended studies on rap-cel will depend on a complete analysis of the safety data. Novartis has stated that it is carefully evaluating the emerging data to determine future steps, suggesting that a reopening could be possible if safety measures are strengthened. Staying informed about these developments allows for informed decisions about your portfolio.

Understanding the clinical research cycle

The suspension of studies is not a defeat but a regular step in the drug development cycle. Phase III clinical trials, such as Remodel-1 and Remodel-2, involve thousands of patients and collect data on efficacy and safety. Positive results in this phase authorize companies to proceed with formal regulatory approval requests. In the case of Remibrutinib, the company has already achieved approvals in the USA and Europe for one indication (chronic spontaneous urticaria) and is now seeking to extend use to more serious diseases like multiple sclerosis.

Understanding this process helps investors better evaluate the potential of a pharmaceutical company like Novartis. The advanced drug industry requires time, significant capital, and tolerance for clinical risks, but the potential rewards (patents, market exclusivity, revenue from multiple indications) justify the investments.

Tax declaration and investment gains

Capital gains from Novartis shares must be declared in the annual tax return form. Whether you hold the stock directly or through funds, it is useful to keep track of value changes to ensure compliance with Swiss tax obligations.

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Source: swissinfo.ch

Frequently Asked Questions

Has Novartis stopped ALL research programs on rapcabtagene autoleucel?: No. Novartis discontinued rap-cel studies in immunology and neuroscience due to three deaths from hemodialysis syndrome. However, the program on rap-cel in oncology is not affected by the suspension and continues as normal. The decision to isolate between the two areas was taken to manage the clinical risks in a precautionary manner.
What is the hemodialytic syndrome Novartis talks about?: According to Novartis, it is a rare complication associated with immune effector cells in the context of CAR-T therapies such as rap-cel. The three reported cases had fatal outcomes, leading the pharmaceutical company to suspend studies to more closely evaluate the safety data. It is an already known risk for this type of therapeutic approach.
What is Remibrutinib and when will it be available for multiple sclerosis?: Remibrutinib is an oral drug that selectively inhibits an enzyme involved in immune cell activation. It showed positive results in the Remodel-1 and Remodel-2 studies for relapsing multiple sclerosis (approximately 2,000 patients globally). Novartis will present the full data at the MStoronto2026 congress in Canada, then seek authorisation from global regulatory authorities. It is already approved in the US and Europe under the name Rhapsido for chronic spontaneous urticaria.
Why did the Novartis stock go up 5% despite the suspension?: The market globally evaluated the two announcements: the precautionary suspension of some trials was offset by the very positive results of Remibrutinib. Since the beginning of the year, the stock has gained 19% and is among the twenty main values of the SMI, reflecting the confidence of investors in the solidity of the company's pipeline.
Bristol-Myers-Squibb has suspended similar studies, is this a precedent?: Yes. US competitor Bristol-Myers-Squibb had previously suspended similar studies as a precaution. This indicates that the risks of CAR-T therapies are already known in the global pharmaceutical industry and that precautionary suspensions are part of the ordinary process of managing clinical research when safety signals emerge.