WASHINGTON (AP) — Shares of drugmaker Sarepta Therapeutics continued to sink Tuesday after the company said it would comply with a Food and Drug Administration request to pause shipments of its gene therapy following several patient deaths.
The decision, announced late Monday, comes just days after the company rebuffed FDA regulators in an extremely unusual decision that alarmed investors and analysts.
Sarepta CEO Doug Ingram said the company seeks a “productive and positive” relationship with FDA and that “maintaining that productive working relationship required this temporary suspension.”
The Cambridge, Massachusetts-based company said it would “ temporarily pause all shipments” of its gene therapy Elevidys for muscular dystrophy at the close of business Tuesday.
It's the latest in a series of highly irregular moves that have rocked company shares for weeks and forced it to lay off hundreds of staffers.
Elevidys is the first gene therapy approved in the U.S. for Duchenne’s muscular dystrophy, the fatal muscle-wasting disease that affects boys and young men, resulting in early death. The one-time treatment was initially approved for boys age 4 and younger who could still walk. Last year, FDA expanded approval to older patients who are no longer able to walk.
The therapy was already under FDA scrutiny after two teenage boys died earlier this year from acute liver injury, a known side effect of the treatment. Then the company last week disclosed a third death with a different therapy: a 51-year-old patient who was enrolled in a company trial for another form of muscular dystrophy.
FDA responded on Friday by asking the company to immediately halt all shipments of Elevidys. Company executives initially refused, noting that the latest death was not tied to Elevidys, its best-selling product.
Wall Street analysts said the company made the right decision to cooperate.
Defying the FDA would have “irreparably damaged the company’s relationship with FDA under the current leadership and administration,” TD Cowen analyst Ritu Baral told investors in a note Tuesday.
Baral estimated the pause in distribution would last three to six months.
The FDA has the authority to pull drugs from the market, but the process can take months or even years. Instead, the agency usually makes an informal request and companies almost always comply. Even in the rare cases when drugmakers haven’t cooperated, the FDA has prevailed after public hearings and appeals.
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FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025. (AP Photo/Jose Luis Magana, File)
SEOUL, South Korea (AP) — A South Korean court sentenced former President Yoon Suk Yeol to five years in prison Friday in the first verdict from eight criminal trials over the martial law debacle that forced him out of office and other allegations.
Yoon was impeached, arrested and dismissed as president after his short-lived imposition of martial law in December 2024 triggered huge public protests calling for his ouster.
The most significant criminal charge against him alleges that his martial law enforcement amounted to a rebellion, and the independent counsel has requested the death sentence in the case that is to be decided in a ruling next month.
In Friday's case, the Seoul Central District Court sentenced Yoon for defying attempts to detain him, fabricating the martial law proclamation and sidestepping a legally mandated full Cabinet meeting.
Yoon has maintained he didn’t intend to place the country under military rule for an extended period, saying his decree was only meant to inform the people about the danger of the liberal-controlled parliament obstructing his agenda. But investigators have viewed Yoon’s decree as an attempt to bolster and prolong his rule, charging him with rebellion, abuse of power and other criminal offenses.
Judge Baek Dae-hyun said in the televised ruling that imposing “a grave punishment” was necessary because Yoon hasn’t shown remorse and has only repeated “hard-to-comprehend excuses.” The judge also restoring legal systems damaged by Yoon’s action was necessary.
Yoon, who can appeal the ruling, hasn’t immediately publicly responded to the ruling. But when the independent counsel demanded a 10-year prison term in the case, Yoon’s defense team accused them of being politically driven and lacking legal grounds to demand such “an excessive” sentence.
Prison sentences in the multiple, smaller trials Yoon faces would matter if he is spared the death penalty or life imprisonment at the rebellion trial.
Park SungBae, a lawyer who specializes in criminal law, said there is little chance the court would decide Yoon should face the death penalty in the rebellion case. He said the court will likely issue a life sentence or a sentence of 30 years or more in prison.
South Korea has maintained a de facto moratorium on executions since 1997 and courts rarely hand down death sentences. Park said the court would take into account that Yoon’s decree didn’t cause casualties and didn’t last long, although Yoon hasn’t shown genuine remorse for his action.
A supporter of former South Korean President Yoon Suk Yeol shouts slogans outside Seoul Central District Court, in Seoul, South Korea, Friday, Jan. 16, 2026. (AP Photo/Lee Jin-man)
Supporters of former South Korean President Yoon Suk Yeol hold signs and flags outside Seoul Central District Court, in Seoul, South Korea, Friday, Jan. 16, 2026. (AP Photo/Lee Jin-man)
A supporter of former South Korean President Yoon Suk Yeol waits for a bus carrying former South Korean President Yoon Suk Yeol outside Seoul Central District Court, in Seoul, South Korea, Friday, Jan. 16, 2026. (AP Photo/Lee Jin-man)
Supporters of former South Korean President Yoon Suk Yeol hold signs as police officers stand guard outside Seoul Central District Court, in Seoul, South Korea, Friday, Jan. 16, 2026. (AP Photo/Lee Jin-man)
Supporters of former South Korean President Yoon Suk Yeol hold signs and flags outside Seoul Central District Court, in Seoul, South Korea, Friday, Jan. 16, 2026. (AP Photo/Lee Jin-man)
Supporters of former South Korean President Yoon Suk Yeol hold signs outside Seoul Central District Court, in Seoul, South Korea, Friday, Jan. 16, 2026. (AP Photo/Lee Jin-man)
A picture of former South Korean President Yoon Suk Yeol is placed on a board as supporters gather outside Seoul Central District Court, in Seoul, South Korea, Friday, Jan. 16, 2026. (AP Photo/Lee Jin-man)
