Movement Alert|Novartis AG Rises 5.19% Overnight, Pauses Eight Autoimmune CAR-T Clinical Trials Following Patient Deaths

Market Focus
Sep 01

On September 1, Novartis AG rose 5.19% overnight, trading at $160.0/share, with turnover of $508,000.

On the news front, Novartis confirmed it has suspended eight early- and mid-stage clinical trials of its CD19-targeted CAR-T cell therapy rap-cel after three fatal cases of immune effector cell-associated hemophagocytic syndrome (IEC-HS). The paused studies span autoimmune and neurological disease indications including lupus and multiple sclerosis. The company stated it is conducting a comprehensive safety review in collaboration with an independent safety committee and regulatory authorities. Notably, Novartis emphasized that its oncology CAR-T pipeline remains unaffected by the suspension. Bristol-Myers Squibb has also paused similar autoimmune CAR-T trials as a precautionary measure.

Beyond the trial pause, Novartis has seen a series of positive developments in recent months, including FDA approval of Pluvicto for PSMA-positive metastatic hormone-sensitive prostate cancer, traditional FDA approval for Fabhalta in IgA nephropathy, and Q2 earnings that beat expectations driven by strong innovative drug sales.

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