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Sarepta Shares Soar on News of Key Drug Critic FDA Exit
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Shares of Sarepta Therapeutics, Inc. (SRPT - Free Report) rose around 27% on Wed, Sep 14 on news that a key critic, Farkas, of its lead pipeline candidate, eteplirsen, has left his job at the FDA, raising hopes of approval of the drug.
The biopharmaceutical company is looking to get eteplirsen approved for the treatment of patients suffering from Duchenne muscular dystrophy amenable to exon 51 skipping.
We remind investors that in Apr 2016, an FDA advisory committee voted against approving eteplirsen for the treatment of DMD. Dr. Ronald Farkas had led the panel and has reportedly been critical of the drug.
One of the most common fatal genetic disorders affecting children around the world, DMD is a devastating and incurable muscle-wasting disease and there is significant unmet need for its treatments.
Following the committee’s decision, the FDA failed to provide a decision on the candidate by the extended Prescription Drug User Fee Act (PDUFA) date of May 26, 2016. The agency informed the company that it was still reviewing the latter’s New Drug Application (NDA) and will try to reach a decision as early as possible.
However, in June, the FDA requested the company to provide dystrophin data from biopsies obtained from the ongoing confirmatory study on eteplirsen, as part of the agency’s ongoing evaluation of the NDA.
Given that Sarepta has no approved product in its portfolio at the moment and that eteplirsen is its lead pipeline candidate, the departure of Farkas definitely improves chances of approval of the drug. However, we cannot rule out the fact that Farkas was not the only member of the advisory committee who had concerns about eteplirsen.
Stocks to Consider
Currently, Sarepta Therapeutics carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Johnson & Johnson (JNJ - Free Report) , Geron Corp. (GERN - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . While Geron and ANI Pharmaceuticals sport a Zacks Rank #1 (Strong Buy), J&J has a Zacks Rank #2.
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Sarepta Shares Soar on News of Key Drug Critic FDA Exit
Shares of Sarepta Therapeutics, Inc. (SRPT - Free Report) rose around 27% on Wed, Sep 14 on news that a key critic, Farkas, of its lead pipeline candidate, eteplirsen, has left his job at the FDA, raising hopes of approval of the drug.
The biopharmaceutical company is looking to get eteplirsen approved for the treatment of patients suffering from Duchenne muscular dystrophy amenable to exon 51 skipping.
We remind investors that in Apr 2016, an FDA advisory committee voted against approving eteplirsen for the treatment of DMD. Dr. Ronald Farkas had led the panel and has reportedly been critical of the drug.
SAREPTA THERAP Price and Consensus
SAREPTA THERAP Price and Consensus | SAREPTA THERAP Quote
One of the most common fatal genetic disorders affecting children around the world, DMD is a devastating and incurable muscle-wasting disease and there is significant unmet need for its treatments.
Following the committee’s decision, the FDA failed to provide a decision on the candidate by the extended Prescription Drug User Fee Act (PDUFA) date of May 26, 2016. The agency informed the company that it was still reviewing the latter’s New Drug Application (NDA) and will try to reach a decision as early as possible.
However, in June, the FDA requested the company to provide dystrophin data from biopsies obtained from the ongoing confirmatory study on eteplirsen, as part of the agency’s ongoing evaluation of the NDA.
Given that Sarepta has no approved product in its portfolio at the moment and that eteplirsen is its lead pipeline candidate, the departure of Farkas definitely improves chances of approval of the drug. However, we cannot rule out the fact that Farkas was not the only member of the advisory committee who had concerns about eteplirsen.
Stocks to Consider
Currently, Sarepta Therapeutics carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Johnson & Johnson (JNJ - Free Report) , Geron Corp. (GERN - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . While Geron and ANI Pharmaceuticals sport a Zacks Rank #1 (Strong Buy), J&J has a Zacks Rank #2.
You can see the complete list of today’s Zacks #1 Rank stocks here.
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Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>