Will Long‑Term Camzyos Data and Real‑World Evidence Change Bristol Myers Squibb's (BMY) Narrative?

Bristol Myers Squibb and Novartis halted clinical trials for CAR-T therapies targeting autoimmune diseases due to safety concerns. Bristol Myers paused a zola-cel study after detecting ICANS cases, while Novartis suspended rap-cel trials following three patient deaths. Both companies are investigating the issues, with Bristol Myers reporting non-fatal effects and Novartis analyzing data. The trials aimed to treat diseases like lupus and rheumatoid arthritis, with initial results showing promise.

Bristol Myers Squibb (BMY) presented positive five-year data for Camzyos at ESC 2026, showing sustained efficacy and safety in treating oHCM. Sales surged 74% YoY to $729M in H1 2026. The FDA accepted a sNDA for adolescent use, with a decision expected by Sept. 30, 2026. Competitors include Cytokinetics (CYTK) with Myqorzo and Edgewise Therapeutics (EWTX) with EDG-7500. BMY shares gained 20.3% YTD, trading at 10.35X forward earnings.

Novartis halted clinical trials for its CAR T therapy rapcabtagene autoleucel after three patient deaths due to severe immune reactions. Bristol Myers Squibb also paused trials for its competitor product zola-cel, citing reversible inflammatory events. Both therapies target CD19, a protein linked to immune responses, but can cause severe immune reactions. Neither company has identified a cause.

Novartis halted eight clinical trials of its experimental cell therapy rap-cel after three patients died from severe immune reactions. The pause affects trials for autoimmune and neurological disorders. Novartis is reviewing the deaths and sharing information with health authorities. Bristol Myers also paused studies of its rival CAR T-cell treatment zola-cel. Novartis shares rose 4% on Tuesday.

Novartis halted eight trials of rapcabtagene autoleucel in autoimmune diseases after three patient deaths. The pause, effective Aug. 24, affects trials for lupus, rheumatoid arthritis, and other conditions. Bristol Myers Squibb also paused its zolacabtagene autoleucel trials as a precaution. Both companies are reviewing the incidents. Two lymphoma and leukemia trials of rapcabtagene autoleucel were not impacted.

Novartis and Bristol Myers Squibb paused autoimmune CAR-T trials due to safety concerns. Novartis halted eight studies of Rap-cel after three fatal cases, while BMS paused Zola-cel trials due to reversible inflammatory events. Novartis also entered a $3.223B deal with Alteogen for subcutaneous biologics. RedHill acquired Rebyota and Clenpiq from Ferring for $12M upfront. Experts argue for real-world insights in obesity care strategy.