The U.S. Food and Drug Administration said on Monday it is recommending the removal of the hold placed on Sarepta Therapeutics' gene therapy Elevidys for patients with a rare muscular disorder who can walk.

The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.

US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.