This regulatory relief, combined with several other compelling catalysts, creates a pathway for the stock to potentially double from current levels to around $40

Stock of Sarepta Therapeutics Inc. (NASDAQ: SRPT) surged 38.89% in Tuesday pre-market following the U.S. Food and Drug Administration's (FDA) recommendation to lift the voluntary hold on Elevidys, Sarepta's gene therapy for Duchenne Muscular Dystrophy.

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency could still carry major consequences for the Duchenne community.

The European Medicines Agency’s drug advisory committee (CHMP) rejected Elevidys for children aged 3 to 7 years who are able to walk, the agency announced Friday. The therapy, which is marketed outside the U.S. by Roche Holding AG (SIX: ROG ), was seeking approval for treating the rare genetic disease that causes progressive muscle weakness.

Sarepta's ELEVIDYS faces a critical FDA decision; an expanded label could significantly widen market reach, targeting all DMD patients. Strong Q3 performance with impressive revenue and EPS ...

The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could further jeopardize Sarepta’s financial future.

– FDA grants accelerated approval to ELEVIDYS for non-ambulatory Duchenne patients – Sarepta will host an investor conference call on June 21, 2024, at 8:30 a.m. ET