Sarepta resumes shipping of gene therapy Elevidys to patients who can walk

By Christy Santhosh

July 28 (Reuters) - Sarepta Therapeutics SRPT.O said on Monday it will resume shipping of its muscular disorder gene therapy to patients who can walk, sending the company's shares 59% higher in extended trading.

The announcement came immediately after the U.S. Food and Drug Administration recommended removal of a voluntary halt placed on Elevidys' use following a probe that showed an eight-year-old boy's death in Brazil was unrelated to the treatment.

Sarepta has been facing intense scrutiny following the death of the two non-ambulatory teenage patients who received Elevidys, as well as a 51-year-old man who had received its experimental gene therapy SRP-9004.

Jefferies analyst Andrew Tsai said the FDA decision significantly improves Elevidys' sales outlook in the near-term, adding that its third-quarter sales may only be impacted "modestly" as U.S. shipments were paused for a week.

However, use of the therapy remains on hold for DMD patients who cannot walk, the FDA said, adding that it is continuing to work with the company while investigating the death of two patients.

The company had halted dosing in non-ambulatory patients, meaning those unable to walk independently, and later complied with the U.S. FDA's request to pause all shipments, along with Roche ROG.S — its partner for sales outside the U.S.