Novartis Pauses Autoimmune Cell Therapy Studies After Deaths

Live updates

1. 30d ago

   Novartis Halts Autoimmune CAR-T Trials Following Fatal Toxicities

   Novartis has suspended eight rap-cel CAR-T therapy trials after fatal toxicities occurred. These deaths challenge the safety thesis that autologous CAR T cell therapies could provide an immune reset for autoimmune diseases with lower toxicity. This suspension follows other recent pipeline failures, including the collapse of the Lp(a) drug pelacarsen and the termination of the ALS drug VHB937. Together, these setbacks contributed to a market value loss exceeding $40 billion and increased investor scrutiny.

   Why it matters

   The company is managing these clinical losses amid a broader 2026 industry trend of heart drug failures. The failure of VHB937 specifically targeted ALS, though other gene-targeting treatments are being explored for rare motor-neuron diseases.

   What is confirmed

   • Novartis suspended eight rap-cel CAR-T therapy trials.
   • The company stopped development of the ALS drug VHB937 after mid-stage trials failed.
   • Novartis lost over $40 billion in market value following several pipeline setbacks.
   • The Lp(a) drug pelacarsen collapsed.

   Still unconfirmed

   • Autologous CAR T cell therapies were intended to deliver immune reset with less toxicity.

   What to watch next

   • Regulatory reviews of rap-cel safety data
   • Investor responses to further pipeline adjustments
   Sources used for this update (2)

   1. www.nature.com — First for RNA therapy: man with rare motor-neuron disease improves after treatment
   2. www.biocentury.com — Fatal toxicities test autoimmune CAR T’s safety thesis
   confidence 90%
2. 33d ago

   Novartis halts ALS drug VHB937 after mid-stage trial failure

   Novartis stopped development of VHB937, a drug targeting ALS, following a failure in mid-stage trials. This decision adds to a string of recent pipeline setbacks for the company, including the suspension of eight rap-cel CAR-T therapy trials and the collapse of its Lp(a) drug pelacarsen. These combined failures have led to increased scrutiny from investors and a loss of over $40 billion in market value. The company continues to face pressure as it manages these clinical losses alongside broader industry trends of heart drug failures in 2026.

   Why it matters

   The failure of VHB937 occurs amid a period of significant volatility for Novartis. The company is struggling with multiple late-stage and mid-stage trial collapses. These losses coincide with a broader pattern of failure in the heart drug sector this year.

   What is confirmed

   • Novartis stopped development of the ALS drug VHB937 after a mid-stage trial failure.
   • Novartis suspended eight rap-cel CAR-T therapy trials.
   • The late-stage trial for the Lp(a) drug pelacarsen failed.
   • Novartis lost more than $40 billion in market value following three clinical failures.

   What to watch next

   • Financial analysis of the impact of VHB937 failure on Novartis market valuation
   • Updates on the status of remaining Novartis pipeline candidates
   Sources used for this update (3)

   1. pharma.economictimes.indiatimes.com — Research & Development
   2. www.statnews.com — Pharmalittle: We’re reading about anxious Novartis investors, patent expirations for biologics, and more
   3. www.globalbankingandfinance.com — Novartis halts ALS drug development after mid-stage trial failure
   confidence 90%
3. 39d ago

   Novartis Market Value Drops After Series of Clinical Failures

   Novartis lost over $40 billion in market value following three clinical failures, including the collapse of its Lp(a) drug pelacarsen and the suspension of eight rap-cel CAR-T therapy trials. While pelacarsen successfully lowered Lp(a) protein particle levels, it failed its late-stage trial. These setbacks coincide with a broader trend of heart drug failures in 2026, including a Novo Nordisk IL-6 program. In contrast, Bristol Myers Squibb reported that its CAR-T therapy arlocabtagene autoleucel met primary and secondary endpoints in a phase 2 trial for blood cancer.

   Why it matters

   The failure of pelacarsen challenges the viability of heart medicines targeting Lp(a). Novartis had previously paused rap-cel studies after three patients died from immune effector cell-associated hemophagocytic syndrome. These events occur as other firms like Amgen and Eli Lilly continue developing similar Lp(a) therapies.

   What is confirmed

   • Novartis's pelacarsen failed a late-stage clinical trial despite lowering Lp(a) protein particle levels.
   • Novartis suspended eight rap-cel CAR-T therapy trials after three patients died from immune effector cell-associated hemophagocytic syndrome.
   • Bristol Myers Squibb's CAR-T cell therapy arlocabtagene autoleucel met primary and secondary endpoints in a phase 2 trial for adults with quadruple-class exposed blood cancer.

   Still unconfirmed

   • Strengthened laws in China should help ensure future deaths are quickly disclosed to the public.

   What to watch next

   • Trial results from Amgen and Eli Lilly regarding Lp(a) lowering therapies
   • Further regulatory disclosures regarding the rap-cel CAR-T therapy deaths
   Sources used for this update (5)

   1. www.nature.com — Two children died from gene therapies in China: where the field goes next
   2. www.marketscreener.com — Bristol Myers' blood cancer cell therapy succeeds in mid-stage trial
   3. www.marketscreener.com — Bristol Myers Squibb's Phase 2 Study of Arlocabtagene Autoleucel Meets Key Endpoints
   4. finance.biggo.com — Stephen Anson: Novartis's Pelacarsen Failure Puts the Entire Lp(a) Drug Field on Trial
   5. finance.biggo.com — Ethan Weiss: Two Trial Flops End the "Genetics Is Undefeated" Era in Heart Drugs
   confidence 90%
4. 42d ago

   Novartis Heart Drug Pelacarsen Fails Final Trial

   Novartis cardiovascular drug pelacarsen failed a late-stage clinical trial despite successfully lowering Lp(a) protein particle levels. The failure raises questions about the effectiveness of an emerging class of heart medicines designed to target Lp(a). Novartis shares fell nearly 4% following the news. This failure adds to recent company setbacks, including the suspension of eight rap-cel CAR-T therapy trials after three patient deaths from immune effector cell-associated hemophagocytic syndrome. Other firms including Amgen and Eli Lilly continue to develop similar Lp(a) lowering therapies.

   Why it matters

   The failure of pelacarsen challenges the assumption that lowering Lp(a) protein particles directly improves heart health. This result impacts broader research into cardiovascular treatments. Novartis is currently managing multiple pipeline setbacks across different therapeutic areas.

   What is confirmed

   • Pelacarsen failed to protect heart health despite lowering Lp(a) protein particle levels.
   • Novartis stock decreased by nearly 4% after the trial failure.

   What to watch next

   • Clinical trial results from Amgen and Eli Lilly regarding Lp(a) therapies
   • Regulatory updates on the suspended rap-cel CAR-T trials
   Sources used for this update (4)

   1. www.statnews.com — Novartis’ experimental cardiovascular drug fails a pivotal study
   2. www.biopharmadive.com — Novartis, Ionis drug failure spurs questions about an emerging class of heart medicines
   3. uk.finance.yahoo.com — Novartis Late-Stage Cardiovascular Outcome Study Fails, Stock Down
   4. www.straitstimes.com — Novartis stock falls nearly 4% as heart-drug failure deepens setbacks
   confidence 100%
5. 45d ago

   Novartis and Bristol Myers Squibb Pause Autoimmune CAR-T Trials After Fatalities

   Novartis suspended eight clinical trials of its rap-cel CAR-T therapy after three patients died from immune effector cell-associated hemophagocytic syndrome (IEC-HS). This rare complication occurs during the treatment of neurological and autoimmune diseases such as rheumatoid arthritis and lupus. Bristol Myers Squibb also paused its Zola-cel trials for autoimmune disorders as a precaution. Both companies have notified regulators and researchers of these safety reviews to address severe immune reactions and inflammatory events.

   Why it matters

   CAR-T therapies engineer a patient's own immune cells to attack specific targets. While used in cancer, expanding these treatments to autoimmune conditions introduces new safety risks regarding systemic inflammation.

   What is confirmed

   • Novartis paused eight clinical trials of rap-cel following three patient deaths.
   • The fatalities resulted from immune effector cell-associated hemophagocytic syndrome (IEC-HS).
   • Bristol Myers Squibb paused its Zola-cel autoimmune trials as a precaution.
   • Rap-cel was being tested for neurological and autoimmune diseases including lupus and rheumatoid arthritis.

   What to watch next

   • FDA or regulatory decisions on the resumption of rap-cel and Zola-cel trials
   • Updated safety protocols for CAR-T enrollment in autoimmune studies
   Sources used for this update (4)

   1. finance.yahoo.com — Novartis (NVS)’s Cell Therapy Promise Meets a Safety Challenge
   2. www.yahoo.com — Novartis, Bristol Myers halt autoimmune CAR-T trials after deaths
   3. www.marketscreener.com — Bristol Myers Squibb Paused Zola-Cel Trials Over Safety Concerns
   4. www.biopharmadive.com — Trailing rivals, AbbVie scores win with dual-acting myeloma drug
   confidence 100%
6. 46d ago

   Novartis and Bristol Myers Squibb Pause Autoimmune CAR-T Trials

   Novartis has suspended eight clinical trials of its CD19-directed CAR-T therapy, rapcabtagene autoleucel (rap-cel), following three patient deaths caused by severe immune reactions. Bristol Myers Squibb also voluntarily paused enrollment in its Zola-cel autoimmune studies due to transient inflammatory events. Both companies informed Endpoints News of these safety reviews. Wall Street analysts suggest that stricter manufacturing, enrollment protocols, and side effect management are necessary to prevent future safety hazards in the development of cell therapies for autoimmune conditions.

   Why it matters

   CAR-T therapies involve modifying a patient's T cells to attack specific targets in the body. While used in oncology, applying this technology to autoimmune diseases carries risks of systemic overreaction. These pauses highlight the volatility of experimental immunotherapies when treating non-cancerous conditions.

   What is confirmed

   • Novartis paused eight clinical trials of its CAR-T therapy rap-cel after three patients died.
   • The Novartis therapy is a CD19-directed CAR-T treatment known as rapcabtagene autoleucel.
   • Bristol Myers Squibb paused enrollment in its Zola-cel autoimmune studies due to transient inflammatory events.
   • Both Novartis and Bristol Myers Squibb reported these pauses to Endpoints News.

   Still unconfirmed

   • Wall Street analysts believe cautious manufacturing and enrollment could help developers avoid future safety hazards.

   What to watch next

   • Regulatory decisions on whether the paused trials can resume with modified protocols.
   Sources used for this update (7)

   1. www.biopharmadive.com — Autoimmune CAR-T faces tough questions after Novartis, Bristol Myers study halts
   2. www.medicalbrief.co.za — Novartis CAR T trials halted after three deaths
   3. www.thejakartapost.com — Health News & Mental Health Trends and Updates
   4. www.insidermonkey.com — Novartis (NVS)’s Cell Therapy Promise Meets a Safety Challenge
   5. finance.yahoo.com — Panmure Liberum says OxfordBiomedica share fall overdone after Novartis and BMS pause trials
   6. www.bioprocessintl.com — Novartis halts CAR-T therapy trials due to three patient fatalities, BMS follows
   7. www.pharmexec.com — Novartis, Bristol Myers Pause Autoimmune CAR-T Trials Over Safety Concerns: Report
   confidence 95%
7. 47d ago

   Novartis and Bristol Myers Pauses Autoimmune CAR-T Trials After Deaths

   Novartis suspended eight cell therapy trials, including immunology and neurology studies, after three patients died from immune effector cell-associated hemophagocytic syndrome. This condition occurs when the immune system overreacts and attacks its own organs. Bristol Myers Squibb also paused some CAR-T trials, citing separate observations of transient and reversible inflammatory events. Both companies halted their respective programs due to these safety concerns regarding experimental cell therapies designed to treat autoimmune conditions.

   Why it matters

   CAR-T therapy traditionally treats cancers by engineering T-cells to attack tumors. Applying this technology to autoimmune diseases aims to reprogram the immune system to stop attacking healthy tissue. These pauses indicate significant safety hurdles in transitioning the therapy from oncology to immunology.

   What is confirmed

   • Novartis paused eight cell therapy trials including immunology and neuro studies.
   • Three patients died during Novartis CAR-T trials.
   • Bristol Myers Squibb paused some CAR-T trials after observing transient and reversible inflammatory events.
   • Novartis deaths were caused by immune effector cell-associated hemophagocytic syndrome.

   What to watch next

   • Regulatory findings on the cause of the inflammatory events at Bristol Myers Squibb
   • Novartis decision on whether to resume trials with modified safety protocols
   Sources used for this update (9)

   1. Endpoints News — Three deaths in CAR-T trials prompt halt by Novartis; Bristol Myers programs also paused
   2. Fierce Biotech — UPDATED: Novartis halts autoimmune CAR-T trials after 3 deaths, as BMS also pauses studies
   3. BioPharma Dive — Novartis, Bristol Myers pause autoimmune CAR-T trials due to safety concerns
   4. WSJ — Novartis Pauses Autoimmune Cell Therapy Studies After Deaths
   5. FirstWord Pharma — Novartis pauses immunology, neuro CAR-T studies after three patient deaths
   6. Bloomberg.com — Novartis Pauses Autoimmune Drug Trials After Three Patients Die
   7. Reuters — Novartis pauses trials of experimental cell therapy after three deaths
   8. www.biospace.com — Novartis pauses CAR T studies due to 3 deaths; BMS follows suit after safety events
   9. www.theweek.in — Novartis pauses 8 cell therapy trials after three die due to severe immune reaction
   confidence 95%