FDA Halts Rocket Pharma’s Gene Therapy Trial After Patient Death and 63% Stock Plunge
In a significant development, the U.S. Food and Drug Administration (FDA) has placed a clinical hold on Rocket Pharmaceuticals’ mid-stage gene therapy trial following the death of a patient. The trial was evaluating RP-A501, an experimental treatment for Danon disease—a rare genetic disorder affecting heart and muscle function. The patient developed capillary leak syndrome, leading to severe complications and subsequent death.
Rocket Pharmaceuticals has voluntarily paused further dosing and is collaborating with the FDA and medical experts to investigate the incident. The company has not provided a timeline for resuming the trial.
The news had an immediate impact on Rocket Pharma’s stock, which plummeted by 63% in premarket trading, falling from $6.27 to $2.30.
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