Sarepta Therapeutics (SRPT) stock plummeted 31.76% in pre-market trading on Monday following the company's announcement of a second case of acute liver failure resulting in death after a patient received its gene therapy treatment, Elevidys. This tragic news has raised serious concerns about the safety of the therapy, which is the only FDA-approved gene therapy for Duchenne muscular dystrophy patients aged four and above.

In response to the incident, Sarepta has taken immediate action by suspending shipments of Elevidys for non-ambulatory patients. The company is also working to convene an independent group of experts in Duchenne and liver health to consider an enhanced immunosuppression regimen for the therapy. Furthermore, Sarepta has informed the FDA and global health authorities about the incident, highlighting the potential regulatory implications of these safety concerns.

The market reaction has been swift and severe, with several analysts downgrading Sarepta's stock. Piper Sandler cut its rating from Overweight to Neutral and slashed its price target from $70.00 to $36.00. This comes after the first instance of death was reported in March, involving a 16-year-old boy who died from acute liver failure months after receiving Elevidys. The repeated occurrence of such a serious adverse event could potentially impact the future of Sarepta's gene therapy program and its market position in treating Duchenne muscular dystrophy.