Sarepta Therapeutics has halted distribution of its gene therapy, Levitas, for advanced Duchenne muscular dystrophy patients after a second patient died from liver failure.

Sarepta Therapeutics has halted distribution of its gene therapy, Levitas, for advanced Duchenne muscular dystrophy patients after a second patient died from liver failure. Both deceased patients were teenagers who had lost the ability to walk, a group for whom the therapy was only recently approved by the FDA despite limited supporting evidence.

The company is now reviewing its safety measures and has suspended its financial outlook for the year. Sarepta's stock has experienced a significant decline following the news, and the future of Levitas for advanced patients remains uncertain as safety concerns intensify.

Sarepta's gene therapy medicine kills patient

We've got a number of downgrades, as you might expect, of Sarepta today, this after the death of a second patient who received the company's gene therapy to treat Duchenne's muscular dystrophy. Angelica Peebles is here. She has more on the story for us. Angelica. Good morning, David. That's right. Sarepta is saying a 15-year-old who received the company's gene therapy, it's called a Levitas, dying from liver failure. And this is the second instance in just a matter of months. The other patient was a 16-year-old boy. And both of these patients who received the treatment for Duchenne, that's a genetic disease that primarily affects boys, and it causes them to gradually lose muscle function. And both of the teens who died had progressed to the point where they weren't able to walk. And that's an important distinction, because, originally, the FDA only approved Levitas for 4- and 5-year-olds who could still walk. And then the agency expanded the label to nearly all Duchenne patients last year. And that was a controversial decision, because there wasn't as much evidence the treatment would work in older, more advanced patients. Now, Sarepta has halted all shipments of the therapy for more advanced patients while it explores a new safety regimen. And CEO Doug Ingram on a call with analysts this morning saying that Sarepta is suspending its 2025 guidance and will update its full-year revenue outlook when it announces second-quarter results. Analysts are projecting $1.5 billion in Levitas sales for the year. That's according to Faxet. But those projections are now, of course, in serious doubt, because it's not clear when or even if the treatment for more advanced patients will resume. It's also possible that safety concerns will cause people who are still eligible to reconsider their decision. And Sarepta, of course, is no stranger to the controversy. But those concerns and those doubts are growing even louder today. Look at that stock, down about 48 percent just today, and over the last year, about 85 percent, guys.

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