Sarepta Therapeutics (NASDAQ:SRPT) is a medical research and a drug development company, located in the United States. The company’s prime products are Morpholion oligomers and synthetic nucleic acid analogs developed under the name NeuGene Antisense.
In October this year, Sarepta Therapeutics (NASDAQ:SRPT) shares saw a dramatic fall. The company aimed at producing drugs that treat Duchenne muscular dystrophy (DMD) faced a 23% decline. This decline took place in a matter of weeks when the company announced its delay in the filing of its new drug application known as eteplirsen.
In its meeting with the FDA back in September, Sarepta (NASDAQ:SRPT) announced that guidance have been handed over for the submission of the drug application. Along with the application, images of 168 week follow up are required for assessment, with MRI data. In addition to this, the release date has also been pushed to mid-2015.
However, according to FDA’s own release, Sarepta (NASDAQ:SRPT) hasn’t followed guideline given to them for the submission. FDA showed willingness to carry out a review that could speed up the eteplirsen’s NDA submission. At this point, Sarepta (NASDAQ:SRPT) is quickly falling under the category of the worst performing biotech stock. If it wasn’t for its Ebola drug data AVI-6002, the company would already be in hot waters. Even that development was conducted without giving much regard to health and safety measures in mind, but due to its effectiveness, the company has managed to get away with it. In addition, Ebola at this stage is a sensitive matter for the Americans, and the health providers seem to be getting desperate for solutions.
The next step at this stage seems unpredictable, till things between Sarepta (NASDAQ:SRPT) and FDA are put to rest. The medicine eteplirson on the other hand keeps producing impressive results. In 144 weeks of treatment, the patients have witnessed a decline in the 6 minute walk test, which indicated benefit over control. On the other hand, patients who switched to eteplirsen after 24 weeks have also witnessed similar results. Therefore, these factors are making the medicine more desirable and claiming urgency to be put on the market shelf, in light of the recent challenges faced due to Ebola.
But this hasn’t been the first time that the company has had issues with the FDA, in the past, numerous such occasions have occurred. Another issue that seems to be surfacing is that Sarepta (NASDAQ:SRPT) is only dependent on the data pool provided by a handful of patients. Whereas, competitors like GalxoSmithKline (NYSE:GSK) and Prosensa (NASDAQ:RNA) usually conduct large trials after facing failures in smaller ones. Similar is expected of Sarepta (NASDAQ:SRPT).
However at this point, it would be too early for investors to make their move. It is better to stick on the sidelines and give Sarepta (NASDAQ:SRPT) a fair shot to prove itself. Now, it’s all in the hands of Sarepta (NASDAQ:SRPT) to make an effort to follow FDA guidance and take measures to change its bad reputation as it will be damaging for the company in the long run.