Sarepta Therapeutics (SRPT) Plunges on FDA Delay

Sarepta Therapeutics (SRPT:US) shares are trading sharply lower this week after the company provided a regulatory update on the Biologics License Application (BLA) for its SRP-9001 therapy.

SRP-9001 is currently with the United States Food and Drug Administration (FDA) for review. The treatment is used on ambulant individuals with Duchene Muscular Dystrophy (DMD) who have a confirmed mutation of the DMD gene.

Sarepta is waiting for FDA approval before SRP-9001 can hit the market. The Massachusetts-based company partnered with Roche (RHHBY:US) to sell its gene therapy internationally. 

The FDA informed Sarepta that it needs “modest additional time” to complete its review. While Sarepta previously expected an answer by May 29, the deadline is now pushed back to June 22.

“The Agency has indicated that, subject to the completion of the BLA review, it is working toward potentially granting an accelerated approval for SRP-9001, initially for use in Duchenne patients ages 4-5 years old,” Sarepta said in a press release.

RBC analyst said the SRPT stock selloff offers a “buying opportunity.”

"Although initial potential label limitation is a slight disappointment, we see limited effect on '9001's medium/long-term opportunity and remain believers into EMBARK and on '9001's long-term prospects.”

Congressman Daniel Goldman reported the $15,000 - $50,000 worth of sale of Sarepta shares in April, when the stock closed at $140.38. He had previously invested in the company, including the $15,000 - $50,000 worth of investment made on March 6 when shares were trading higher. Rep. Josh Gottheimer also bought some Sarepta shares in March.

On Thursday, the stock closed at $128.86.