(Bloomberg) — Sarepta Therapeutics Inc. is slicing greater than one-third of its workforce and can add a black field warning label to its gene remedy for a deadly muscle dysfunction after two affected person deaths raised doubts about the way forward for the corporate.
The Cambridge, Massachusetts-based biotech firm stated Wednesday it will get rid of about 500 workers as a part of a sweeping restructuring. It’s additionally pausing a number of medication in its pipeline. Sarepta stated the strikes would contribute to an estimated $400 million in annual price financial savings.
The corporate agreed to warn docs and sufferers in regards to the threat of liver failure from Elevidys, its gene remedy to deal with Duchenne muscular dystrophy, on the request of the US Meals and Drug Administration. Black field labels are essentially the most critical security warnings a drug can have, and point out extreme or probably lethal problems.
Sarepta stated the job cuts will assist it keep entry to a $600 million revolving credit score line and create money stream that would assist it repay a convertible observe due in 2027.
The corporate additionally disclosed preliminary second-quarter outcomes displaying complete internet product income of $513 million. Greater than half got here from Elevidys.
Final month, Sarepta reported {that a} second teenage boy died of acute liver failure whereas being handled with its $3.2 million gene remedy. Each fatalities occurred in sufferers who weren’t in a position to stroll due to the muscle-wasting illness.
On the time, the corporate suspended its 2025 income steering, and pledged to take a cautious take a look at its prices going ahead. Sarepta additionally paused a medical trial and halted shipments of the drug for non-ambulatory sufferers.
Sarepta stated it is going to submit a plan to the FDA for sufferers who can’t stroll that features suppressing their immune programs earlier than administering Elevidys, which can scale back their threat of problems. It’s going to additionally focus on a path to resuming cargo of the remedy for these sufferers, sometimes older boys and younger males.
The FDA is investigating the Elevidys deaths. The fatalities pose one of many first massive checks for Vinay Prasad, the brand new head of the regulator’s gene remedy division. As an educational on the College of California San Francisco, previous to his present function, he was extremely important of the FDA’s expedited approval course of and its use for Sarepta’s gene therapies particularly.
In social media posts in March, Prasad questioned Sarepta’s remedy, saying it “appears to be killing children” with Duchenne and “destroying their livers.”
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