12:25 PM EDT, 04/03/2025 (MT Newswires) -- Sarepta Therapeutics ( SRPT ) shares fell nearly 7% in recent Thursday trading after media reports that the European Medicines Agency has placed a temporary hold on enrollment and dosing in multiple ongoing trials of the company's gene therapy, Elevidys, for Duchenne muscular dystrophy.

Sarepta said on March 18 that a young patient in the US died from acute liver failure after receiving Elevidys. Acute liver injury is a known potential side effect of the therapy, but the company said liver failure leading to death had not been previously reported in over 800 treated patients.

RBC Capital Markets said in a note emailed Thursday that the EMA's clinical holds are "temporary until further investigations into the cause of the death."

The firm said the EU pause "reflects regulatory concerns which may incrementally slow key ongoing studies and speak to approvability risk in Europe, though [it] may not be altogether surprising" given the circumstances.

Oppenheimer said in a note that the hold does not appear to impact the timeline for a European marketing authorization decision, which Roche, Sarepta's ex-US partner, submitted last summer and is expected in the first half of this year.

The firm added that "the risk-benefit still favors Elevidys in [Duchenne muscular dystrophy] with no other gene therapy treatment options available."

UBS said in a note emailed Thursday that Elevidys has full US approval for ambulatory patients aged four and older, while Roche holds ex-US rights, with Sarepta receiving royalties.

The firm emphasized that the US market remains the primary driver of Sarepta's valuation. It also noted that while a marketing application is under review in Europe, investors had already assigned a low probability of approval.

The EMA and Sarepta didn't immediately respond to requests for comment by MT Newswires.

Price: 58.34, Change: -4.13, Percent Change: -6.61