Boston, MA 04/21/2014 (wallstreetpr) – Sarepta Therapeutics Inc (NASDAQ:SRPT) has experienced a drastic upheaval after the announcement that the U.S. Food and Drug Administration has accepted its new drug application. The drug is quite controversial and has been in the limelight because of the same. But all seems well, now that the company seems to be succeeding in its endeavors. If this remains the case, then Sarepta will report profits like never before. Sarepta has shown that it would not stop unless a breakthrough comes around. This acceptance could be Sarepta’s breakthrough on a new drug project.
Muscular Dystrophy Drug
Reportedly, Sarepta Therapeutics Inc (NASDAQ:SRPT) has revealed that the FDA has sent it a detailed list of guidelines, which have to be followed while testing the new muscular dystrophy drug, which the company has been trying to make. This came as a relief to Sarepta after the previous rejection of its application by the FDA. This had brought a new ray of hope for Sarepta, which is now feeling positive about the filing of a new application for the approval of the drug by the end of this year.
After the revelation of this news regarding the guidelines being sent by the FDA, the stocks of the company were up by almost 50% yesterday. With this Sarepta, hit a five-month high. FDA had previously rejected the application, which was filed on November last year saying that the filing was premature.
The new drug would be called Eteplirsen, which would seek to cure the rare muscle degenerative disease more popularly known as the Duchenne muscular dystrophy. Through the previous application, Sarepta was aiming towards achieving an accelerated approval from the FDA. In the new letter that the FDA sent Sarepta they had mentioned that the six minute test for walking could be regarded as a finding on the intermediate clinical endpoint and could help Sarepta in getting an accelerated approval. The FDA also expressed concerns over the interpretation of certain data in the application, which Sarepta Therapeutics Inc (NASDAQ:SRPT) proposed to address in the review.
