Sarepta Therapeutics (SRPT) Halted Ahead of FDA AdCom

Sarepta Therapeutics (SRPT) Issues Commentary on Adverse FDA Panel Vote for Eeplirsen in DMD

Sarepta Therapeutics, Inc. (NASDAQ: SRPT) announced that the U.S. Food and Drug Administrations (FDA) Peripheral and Central Nervous System Advisory Committee (PCNSC) met to review the new drug application (NDA) for eteplirsen as a treatment for Duchenne muscular dystrophy amenable to exon 51 skipping. The advisory committee voted 6-7 against the finding of substantial evidence from adequate and well controlled studies that show that eteplirsen induces production of dystrophin to a level that is reasonably likely to predict clinical benefit (FDA Question #2). The advisory committee voted 3 7, with three abstentions, against finding substantial... More

FDA Panel 6 YES, 7 NO That Eteplirsen Shows Clinical Benefit (SRPT)

FDA Panel votes 6 YES 7 NO that Sarepta Therapeutics (NASDAQ: SRPT) provided substantial evidence eteplirsen induces dystrophin to level reasonably likely to predict clinical benefit.

NOTE: One panelist initially voted 'no' but he meant to vote 'yes'

FDA Panel Starts Getting Cautious on Sarepta's (SRPT) Eteplirsen

Sarepta Therapeutics (NASDAQ: SRPT) could see some wild trading once it's FDA panel for DMD drug eteplirsen is completed today. The following was posted to Twitter on Monday, hinting that the committee is taking a more cautious tone on the drug.

Shares are... More

Sarepta Therapeutics (SRPT) Active Ahead of Today's FDA AdCom and Expected Halt

Sarepta Therapeutics (NASDAQ: SRPT) is trading up ahead of today's FDA AdCom. After plunging Thursday on negative biased briefing documents, shares surged on Friday on positive draft questions. Shares may be halted shortly ahead of the panel.

Baird 'Incrementally Positive' on Sarepta (SRPT) Following 'Shocking Move' by FDA

Baird analyst Brian Skorney is incrementally positive on the FDA's move to include voting questions on Sarepta Therapeutic (NASDAQ: SRPT) eteplirsen.

The analyst called it a "shocking move.

"The final question will gauge panelists' read on the efficacy of the... More

Sarepta (SRPT) Voting Questions Rekindle Hope, but RBC Still Expects a Negative Panel

RBC Capital analyst, Simos Simeonidis, weighed in Sarepta Therapeutics (NASDAQ: SRPT) after the FDA posted 5 voting questions and explanatory discussion points ahead of Monday's eteplirsen panel.

"We view the fact that panel members will have to vote on Monday as an incremental positive for SRPT, simply because of the understandable pressure committee members will be under, in the presence of the DMD... More

FDA Draft Questions Changes Calculus on Sarepta (SRPT) Approval 'to Some Extent' - Janney Montgomery Scott

Janney Montgomery Scott weighed in on Sarepta Therapeutic (NASDAQ: SRPT) after the FDA released draft questions which re-ignited optimism for a positive outcome surrounding eteplirsen.

The analyst first notes there was not clear voting questions during BioMarin's drisapersen review.... More

Leerink Remains Skeptical Despite FDA Draft Questions on Sarepta (SRPT)

Leerink Partners analyst Joseph Schwartz weighed in on Sarepta Therapeutic (NASDAQ: SRPT) after the FDA released draft questions which re-ignited optimism for a positive outcome surrounding eteplirsen.

"Although voting question #7 could appear to imply a possible positive vote (and an... More