Sarepta Therapeutics (SRPT) Delays Filing for Muscular Dystrophy Drug

Shares of Sarepta Therapeutics Inc. (SRPT) were trading down -7.86 or -33.36 percent to $15.70 per share in premarket trading on Monday. The company announced today it was delaying its filing for approval of its drug Eteplirsen for muscular dystrophy until 2015 following a request for more information on the drug from the FDA. Sarepta shares closed at $23.56, up +0.52 or +2.26 percent in Friday's regular trading session.

Cambridge, Massachusetts based Sarepta Therapeutics, originally called AVI Biopharma changed its name and ticker symbol in July of 2012.
The company's main products are called Morpholino oligomers or PMOs, synthetic nucleic acid analogs, which are being developed under the name NeuGene Antisense. Because morpholino oligomers can form double stranded complexes with RNA which are sequence specific, they can be applied in antisense therapy. Morpholinos have a broad range of applications including treating Duchenne muscular dystrophy, West Nile Virus, SARS, Influenza, Dengue fever, Hepatitis C and Ebola.

The company's drug, eteplirsen was given guidance by the FDA in April for the approval of the drug before completing late stage evaluations. The FDA had previously deemed the approval of the drug as "premature" at the end of last year.

Eteplirsen is under development for the treatment of Duchenne muscular dystrophy, a degenerative muscle disorder which impedes muscle movement and affects one in 3,6000 newborn males that die prematurely by the age of 30. The FDA said that it would need further discussions to determine the elements constituting a complete application for the drug.

Sarepta Chief Executive Officer, Chris Garabedian said in a statement that, "We are committed to satisfying the FDA's updated requests for these specific data to be included as part of an NDA (New Drug Application) submission and will continue to work with the agency toward the goal of a complete and acceptable NDA filing," He continued saying, "We believe all of the data requests and additional FDA discussions that have currently been outlined can be completed in time for an NDA submission by mid-year 2015. Obtaining an FDA approval of eteplirsen for the DMD patients who may benefit from the drug continues to be our highest priority."

In related news, there is growing concern that Sarepta may be running out of money to continue its drug trials. The company's cash flows have been severely depleted between developing eteplirsen and Sarepta's Ebola drug, AVI-7537. Nevertheless, the company had a share offering of 2.65 million shares in April that raised $94.5 million.

Sarepta stock has been extremely volatile since last year when the stock traded as low as $12.12 per share. The stock hit its yearly high of $44.03 per share last October. Despite the company's pipeline for new drugs showing promise, the company doesn't expect to turn a profit until 2017. With today's news, the stock looks like it may be ready to test its yearly lows.

Other News About Sarepta Therapeutics
A Promising Experimental Ebola Drug Goes Overlooked
Sarepta's AVI – 7537 drug has shown promise in treating the Ebola virus.
Sarepta Therapeutics Announces Publication of Ebola and Marburg Phase I Clinical Study Results in Antimicrobial Agents and Chemotherapy
Company announces publication of two single dose studies for its Ebola and Marburg drugs.

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Published on Oct 27, 2014
By Jay Hawk
Jay Hawk
Jay Hawk enjoyed a 12-year professional financial markets career incorporating extensive first hand futures and options experience obtained by trading in the stock, commodity and forex markets on U.S. exchanges. Since retiring as a full-time financial market professional, he has been actively trading stock, commodities, forex and options for his own account and managing funds for others, as well as writing financial market commentary and educational articles.

Copyrighted 2020. Content published with author's permission.

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