Despite Negative FDA Panel, Needham & Company Sees Approval of Sarepta's (SRPT) Eteplirsen as Early as Next Year

Go back to Despite Negative FDA Panel, Needham & Company Sees Approval of Sarepta's (SRPT) Eteplirsen as Early as Next Year

Sarepta Therapeutics (SRPT) Continues Grind Higher from Morning Lows

April 26, 2016 12:45 PM EDT

Sarepta Therapeutics (NASDAQ: SRPT) continues to recover off morning lows related to a negative FDA panel. After opening down 46%, shares are now down 27.6% to $10.82.

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Piper Jaffray Downgrades Sarepta Therapeutic (SRPT) to Underweight

April 26, 2016 7:28 AM EDT

Piper Jaffray downgraded Sarepta Therapeutic (NASDAQ: SRPT) from Neutral to Underweight with a price target of $6.00 (from $15.00).

Analyst Edward Tenthoff commented, "Eteplirsen received negative votes from the FDA's Peripheral and Central Nervous System Drugs AdCom. We were struck by the contentious tone... More

Sarepta Therapeutic (SRPT) PT Cut to $5 at RBC Capital

April 26, 2016 7:14 AM EDT

RBC Capital analyst Simos Simeonidis cut his price target on Sarepta Therapeutic (NASDAQ: SRPT) to $5.00 (from $7.00) following an negative FDA panel. The firm maintained a Sector Perform rating.

Simeonidis commented, "In one of the most emotional and highly charged Advisory Committee meetings in... More

Sarepta Therapeutics (SRPT) Resumes Trading; Shares down 53%

April 26, 2016 7:11 AM EDT

Sarepta Therapeutics (NASDAQ: SRPT) has resumed trading and is down 53% current to $7.

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Sarepta Therapeutics (SRPT) to resume trading at 7:10AM ET

April 26, 2016 7:07 AM EDT

Sarepta Therapeutics (NASDAQ: SRPT) to resume trading at 7:10AM ET after negative FDA panel

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Sarepta Therapeutic (SRPT) PT Cut to $7 at Jefferies Following Negative AdCom

April 26, 2016 6:49 AM EDT

Jefferies analyst Gena Wang lowered her price target on Hold-rated Sarepta Therapeutic (NASDAQ: SRPT) to $7.00 (from $14.00) following a negative FDA Adcom.

Wang commented, "Largely in-line with our thesis and FDA's analyses, the panelists voted negative on eteplirsen efficacy despite strong pressure from pts... More

Oppenheimer Downgrades Sarepta Therapeutic (SRPT) to Perform

April 26, 2016 6:40 AM EDT

Oppenheimer downgraded Sarepta Therapeutic (NASDAQ: SRPT) from Outperform to Perform after the FDA hosted an AdCom to discuss SRPT's eteplirsen NDA and the result of 5-voting questions was unambiguously negative.

Analyst Christopher Marai commented, "We'd have viewed even a positive vote on... More

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

April 26, 2016 5:58 AM EDT

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