Sarepta (SRPT) Analysts Split on Accelerated Eteplirsen Approval - Barron's
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Sarepta Therapeutics (Nasdaq: SRPT) is comfortably in positive territory Monday following positive commentary in Barron's over the weekend.
Traders and investors are watching Sarepta as the FDA nears a decision on its Duchenne muscular dystrophy (DMD) drug, eteplirsen. Shares of Sarepta have traded strong since positive results from a Phase 2B trial on DMD were released last October.
Eteplirsen produced a significant level of the protein dystrophin in the Phase 2B. Without dystrophin, muscles begin to deteriorate throughout the body.
Analysts suspect that eteplirsen could generate about $500 million in sales annually.
There is currently no cure for DMD, which generally ends in death at the age of 25 to 30. Higher-multiples are placed on companies with so-called orphan drugs in their pipeline. About 35,000 in the U.S. and European Union are said to have DMD.
Though the FDA generally requires three phases of testing before it considers passing a drug, there have been exceptions of passing after two trials if the drug produced significant results and addressed an unmet need. Sarepta will meet with the FDA month and guidance will be issued in April about whether eteplirsen will get accelerated approval status or whether a Phase 3 will need to be conducted.
Analysts currently peg accelerated approval at 50 percent given the most recent trial had just 12 boys in it, but most believe the drug will pass muster through any other testing its is put through.
Speculation sees Sarepta moving back to $20 if is doesn't seek accelerated approval, indicating that the FDA still has concerns. Shares could also pop to $50 if it is granted the measure, Barron's notes.
Sarepta is up over 5 percent on Monday's session.
Traders and investors are watching Sarepta as the FDA nears a decision on its Duchenne muscular dystrophy (DMD) drug, eteplirsen. Shares of Sarepta have traded strong since positive results from a Phase 2B trial on DMD were released last October.
Eteplirsen produced a significant level of the protein dystrophin in the Phase 2B. Without dystrophin, muscles begin to deteriorate throughout the body.
Analysts suspect that eteplirsen could generate about $500 million in sales annually.
There is currently no cure for DMD, which generally ends in death at the age of 25 to 30. Higher-multiples are placed on companies with so-called orphan drugs in their pipeline. About 35,000 in the U.S. and European Union are said to have DMD.
Though the FDA generally requires three phases of testing before it considers passing a drug, there have been exceptions of passing after two trials if the drug produced significant results and addressed an unmet need. Sarepta will meet with the FDA month and guidance will be issued in April about whether eteplirsen will get accelerated approval status or whether a Phase 3 will need to be conducted.
Analysts currently peg accelerated approval at 50 percent given the most recent trial had just 12 boys in it, but most believe the drug will pass muster through any other testing its is put through.
Speculation sees Sarepta moving back to $20 if is doesn't seek accelerated approval, indicating that the FDA still has concerns. Shares could also pop to $50 if it is granted the measure, Barron's notes.
Sarepta is up over 5 percent on Monday's session.
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