Sarepta Stock Surges on Positive FDA Vote

Sarepta Therapeutics (SRPT:US) shares are offered over 30.77% higher on Monday after the U.S. Food and Drug Administration (FDA) voted in favor of accelerated approval of the company’s experimental gene therapy for a debilitating muscle disease (SRP-9001).

FDA’s Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted 8 to 6 in support of accelerated approval of SRP-9001, the company said.

The approval significantly increases the likelihood of an accelerated approval by the FDA, hence investors moving into SRPT to reflect the new situation. 

It is expected that the treatment could be approved by the FDA as soon as this month. It is also important to note that the vote is not binding but the FDA rarely decides against these recommendations.

“Today’s advisory committee outcome is extremely important to the patient community, who are in urgent need of new therapies,” said Doug Ingram, president and chief executive officer, Sarepta. 

“With the May 29 action date our top priority, we will work collaboratively with the FDA to complete the review of our BLA for SRP 9001.”

Congress members Josh Gottheimer and Daniel Goldman bought the SRPT stock on March 06, when it closed at $155.99. The timing of these trades wasn’t perfect as the stock previously erupted by over 30% at the end of February. 

However, shares erased practically all gains on the report from April that said the FDA was leaning toward rejecting the company’s Duchenne muscular dystrophy gene therapy before a top official intervened. 

Overall, Sarepta shares are up about 25.91% year-to-date.