eteplirsen

Following Sarepta Therapeutics Inc. (NASDAQ: SRPT) receiving the U.S. Food And Drug Administration's accelerated approval for eteplirsen for treating exon 51 skipping amenable Duchenne's muscular dystrophy, William Blair upgraded its rating and price target. The firm sees the approval as...

Shares of Sarepta Therapeutics Inc (NASDAQ: SRPT) soared higher by 80 percent Monday and hit a new 52-week high of $52.30 after the U.S. Food and Drug Administration granted the company with an accelerated FDA approval for its Eteplirsen drug. Related Link: Sarepta's Eteplirsen Receives...

Shares of Sarepta Therapeutics Inc (NASDAQ: SRPT) soared more than 80 percent Monday morning after the U.S. Food and Drug Administration confirmed in a letter it granted the company with an accelerated approval for its Eteplirsen drug. Sarepta's drug is intended for the treatment of...

SunTrust said the "logical decision" for the FDA would be to deny approval for Sarepta Therapeutics Inc (NASDAQ: SRPT)'s Eteplirsen drug for the treatment of Duchenne Muscular Dystrophy. DMD is a genetic disorder caused by an absence of dystrophin, a protein that helps keep muscle...

Checks indicate that Dr. Ronald Farkas has left the FDA and his name no longer appeared in the HHS employee directory. Oppenheimer’s Michelle Gilson said this was “a positive signal for eteplirsen approval” and maintained an Outperform rating on Sarepta Therapeutics Inc (...

Benzinga has learned that Dr. Ronald Farkas, leader of the clinical team for Sarepta Therapeutics Inc’s (NASDAQ: SRPT) Eteplirsen NDA, has left the FDA. This may lend upside to the company’s shares “due to a read-through that is another step toward approval,” JMP...

The "miracle drug" that could save the lives and well-being for hundreds of people may have just received some great news. Dr. Ron Farkas has left the U.S. Food & Drug Administration, people familiar with the matter told Benzinga. Why would his departure raise hope for the "...

A Wall Street Journal opinion piece suggested some eteplirsen reviewers might have escalated the conflict within the agency through a “differing-professional-opinions” (DPO) proceeding. Janney’s Debjit Chattopadhyay maintained a Neutral rating on Sarepta Therapeutics Inc (...

Last week, Sarepta Therapeutics Inc (NASDAQ: SRPT)'s Phase 3 ESSENCE study was updated and extended from 48 to 96 weeks. To many, the extension of the endpoint signaled a lack of confidence in the study's readout, however Baird thinks otherwise. Baird's Interpretation Despite the market's bearish...

It’s been a wild ride so far this year for shareholders of Sarepta Therapeutics Inc (NASDAQ: SRPT). The year got off to a disastrous start back in January when the stock plummeted 55 percent in a single trading day after the FDA released advisory committee briefing documents that were highly...

Sarepta Therapeutics Inc (NASDAQ: SRPT) was up 28.97 percent after the FDA requested Dystrophin data prior to making a decision on Eteplirsen NDA in addition to Wedbush upgrading the company to Outperform with a price target of $36.00. United Natural Foods, Inc. (NASDAQ: UNFI) rose 10.74 percent...

The FDA has requested Sarepta Therapeutics Inc (NASDAQ: SRPT) for dystrophin data in the ongoing evaluation of the eteplirsen New Drug Application [NDA]. Wedbush’s Heather Behanna upgraded the rating for the company from Neutral to Outperform, while raising the price target from $14 to $36...

Shares of Sarepta Therapeutics Inc (NASDAQ: SRPT) plunged more than 20 percent on Thursday after reports surfaced that the U.S. Food and Drug Administration may pressure the company to provide its Duchenne muscular dystrophy patients with at-cost access to its eteplirsen therapy on a "...

Sarepta Therapeutics Inc (NASDAQ: SRPT), a developer of innovative RNA-targeted therapeutics, revealed Wednesday that the U.S. Food and Drug Administration has notified that they were continuing their review in respect of Eteplirsen. The company indicated that the regulator was holding internal...