Sarepta Rockets And Breaks Out As FDA Smooths The Path For Its Gene Therapy

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Sarepta Therapeutics (SRPT) could snag an accelerated approval for its muscular dystrophy gene therapy, analysts suggested Wednesday as SRPT stock rocketed.

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The view comes after Sarepta said late Tuesday the Food and Drug Administration won’t hold an advisory committee meeting to discuss its gene therapy, SRPT-9001. These meetings allow experts to debate the merits and risks of some drugs. Now, Sarepta is likely on the path to accelerated FDA approval of its gene therapy, Needham analyst Gil Blum said in a note to clients.

“This turn of events clears out potential headwinds ahead of the (approval) date, turning this into a true binary,” he said. “Sarepta was trading up premarket and we expect the name to have a strong opening this morning.”

In premarket trading on today’s stock market, SRPT stock surged 17.9% near 143.90. The news sent shares skyrocketing above a buy point at 134.18 out of a flat base, according to MarketSmith.com.

SRPT Stock: No Deficiencies In Application

Sarepta’s gene therapy aims to tackle Duchenne muscular dystrophy. Patients with this form of the muscle-wasting disease don’t make enough dystrophin, a protein involved in muscle strength. Sarepta’s treatment inserts a shortened version of the gene that codes for the dystrophin protein.

Promisingly, Sarepta said the FDA hasn’t noted any significant safety concerns, Blum said. Further, the agency hasn’t found any deficiencies in the clinical data submitted to support approval.

“We view these developments positively and believe they further support our bullish position on an accelerated approval for SRPT-9001,” Blum said.

He kept his buy rating and 200 price target on SRPT stock.

Shares have a strong Relative Strength Rating of 94, according to IBD Digital. This puts Sarepta stock in the top 6% of all stocks when it comes to 12-month performance.

Follow Allison Gatlin on Twitter at @IBD_AGatlin.

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