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Sarepta Spikes 20%, Feuerstein Says Company Can Win FDA Drug Approval

Sarepta Spikes 20%, Feuerstein Says Company Can Win FDA Drug Approval

Shares of Sarepta Therapeutics Inc (NASDAQ: SRPT) spiked higher by around 20 percent Thursday morning after The Street's biotech expert Adam Feuerstein penned an article titled "Why Sarepta Can Ultimately Win FDA Drug Approval."

Shares of Sarepta were hard hit after a federal advisory panel voted that the company's eteplirsen drug for the treatment of Duchenne muscular dystrophy (DMD) was not effective.

Feuerstein stated that while the advisory panel members ultimately decided Sarepta's clinical data wasn't strong enough to justify approval, senior FDA officials, including Dr. Janet Woodcock, "spent a lot of time at Monday's panel making supportive statements about eteplirsen."

Related Link: Eteplirsen Not Effective: Sarepta Therapeutics Plunges 50%

A final decision to approve or reject Sarepta's drug is expected to come in May.

Feuerstein noted Woodcock has the power to overrule concerns about Sarepta's drug that were raised by the panel. Following Monday's hearing, Woodcock was seen talking with families affected by the disease.

"If Woodcock agreed with all the bad things said about eteplirsen on Monday night, if she had no plans to overrule or cast aside the recommendations against approval, why did she go out of her way to meet with DMD boys and their families immediately after the meeting ended," Feuerstein wrote.

"Could the answer be that Woodcock plans to approve eteplirsen?" he added.

Posted-In: Adam Feuerstein DMD Duchenne Muscular DystrophyBiotech News FDA Movers General Best of Benzinga


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