Sarepta Stock Slumps After FDA Opens Probe Into Patient Death, Analyst Sounds Alarm

Brokerage H.C. Wainwright on Wednesday opined that there will be” little intrinsic value” in Sarepta Therapeutics (SRPT) if its cell therapy for Duchenne Muscular Dystrophy called Elevidys is withdrawn.

The investment bank’s comments come on the heels of the U.S. Food and Drug Administration announcing that it is investigating the death of two pediatric patients with Duchenne Muscular Dystrophy (DMD) following treatment with Elevidys.

The FDA said in a statement on Tuesday that the deaths of the two patients appear to be related to treatment with Elevidys, and they were hospitalised with elevated liver enzymes less than two months after treatment with Elevidys.

FDA is investigating the risk of acute liver failure with serious outcomes, including hospitalization and death, following Elevidys, and is evaluating the need for further regulatory action, the agency said.

H.C. Wainwright reiterated a ‘Sell’ rating on Sarepta on Wednesday with a $10 price target. The firm views the FDA as a potential headwind for Sarepta now.

Shares of Sarepta traded over 7% lower on Wednesday afternoon.

Sarepta announced the death of a second patient following treatment with Elevidys earlier this month. The first death was announced in March. Both non-ambulatory patients suffered from acute liver failure.

Earlier this month, Sarepta announced that shipments of Elevidys to non-ambulatory patients are suspended until an enhanced immunosuppressive regimen is approved to mitigate the risk of acute liver failure. The company is developing a regimen, it said.

For ambulatory patients, however, the company proposed no changes to treatment.

The company also halted dosing in a clinical study evaluating Elevidys in older ambulatory and non-ambulatory individuals living with Duchenne muscular dystrophy, in consensus with the FDA.

On Stocktwits, retail sentiment around Sarepta remained unmoved within ‘neutral’ territory over the past 24 hours while message volume remained at ‘normal’ levels.

SRPT stock is down by about 85% this year and by about 89% over the past 12 months.

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