FDA Commish Says Sarepta's DMD Study Should Be Retracted

It looks like Sarepta Therapeutics Inc SRPT's Eteplirsen may not be out of the woods just yet. 

A letter from U.S. Food & Drug Administration Commissioner Robert Califf is calling for the drug's latest study to be retracted.

The 13-page memo is dated Friday, September 16, but was made public Thursday morning and originally circulated by Retraction Watch and Stat News. 

"In view of the scientific deficiencies identified in this analysis, I believe it would be appropriate to initiate a dialogue that would lead to a formal correction or retraction (as appropriate) of the published report," Califf said.

The Duchenne muscular dystrophy "miracle drug" was thought to be on the fast track for approval after its harshest critic, Dr. Ron Farkas, left the FDA earlier this month.

Related Link: Sarepta Share Price Doubles Since Benzinga Broke News of Dr. Farkas' FDA Departure

"If we were to approve eteplirsen without substantial evidence of effectiveness...we would quickly find ourselves in the position of having to approve a myriad of ineffective treatments for groups of desperate patients," the letter concluded.

Shares of Sarepta sold off nearly $2 as the news hit, however, the stock traded recently at $57.94, up 3 percent on the day.

Benzinga Pro subscribers were originally alerted at 10 a.m. ET.