Sarepta Faces Fresh Setback. Why Now’s Not the Time to Buy the Stock.

Sarepta stock is down about 90% so far in 2025. (VINCENZO PINTO/AFP via Getty Images)

Sarepta Therapeutics was falling again Tuesday after it agreed to halt shipments of its drug Elevidys, ultimately caving in to pressure from the Food and Drug Administration.

When a stock sees a large decline, it can be tempting to buy the dip. In Sarepta’s case, however, that would be a risky move as it isn’t clear how the company will fill the gaping hole left by Elevidys that will inevitably hit revenue.

The stock has zero intrinsic value without Elevidys on the market, H.C. Wainwright analyst Mitchell Kapoor wrote Monday, expecting the treatment to be permanently removed from the market.

“It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension,” CEO Doug Ingram said in a statement after the bell Monday. It’s unclear if or when shipments could be resumed.

It follows a brief but tense face-off between the gene therapy drug developer and the FDA over whether to pause shipments of its experimental experimental gene therapy Elevidys for Duchenne muscular dystrophy following patient deaths.

Sarepta stock is down about 90% since the start of the year, and Wall Street is divided on the stock.

Some analysts, such as Jefferies’ Andrew Tsai, still see room for shares to grow and kept Buy-ratings on shares.

However, Tsai highlighted that he’s awaiting further next steps by the FDA which could potentially pull Elevidys permanently from the market. He echoes other analysts who are holding off recommending the stock to clients amid heightened uncertainty. For now, Tsai maintained a $40 price target on Sarepta shares.

After Sarepta refused to comply with a FDA request to voluntarily pause shipments Friday, the regulator said it was halting Sarepta’s clinical trials for its limb girdle muscular dystrophy (LGMD) program. It was “not afraid to take immediate action when a serious safety signal emerges,” FDA said in a statement.

Late Monday, Sarepta said the shipment pause of Elevidys would allow it to respond to any requests for information and allow the company and the FDA to complete the safety labeling process.

In the last reported quarter, Elevidys accounted for about 50% of Sarepta’s total revenue. Shares were down 3.7% to $12.80 early Tuesday.

Write to Elsa Ohlen at elsa.ohlen@barrons.com