See feature articles below: (Nasdaq: SRPT)
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Report on : (Nasdaq: SRPT)
Sarepta Therapeutics, Inc (NASDAQ:SRPT) released its first quarter results recently. The company reported a non-Gaap net loss of $ 52.5 million or $ 1.15 per share when compared to non-Gaap net loss of $ 47.4 million or $ 1.15 per share for first quarter of 2015. The research and development expenses were $ 35.9 million for the first quarter 2016 when compared to $ 36.7 million for last year. General and administrative expenses increased to $ 16.6 million for this year when compared to $ 11 million for last year. The company’s cash position at the end of first quarter of 2016 was $140.6 million which decreased due to commercial launch activities and ongoing operations. The cash position was $ 204 million last year during the same period.
“The Peripheral and Central Nervous System Advisory Committee met last week to review eteplirsen for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping, and we await our May 26 PDUFA date,” said Edward Kaye, M.D. Sarepta’s interim chief executive officer and chief medical officer.” “Following the FDA’s decision, we plan to provide a clinical and corporate update.”
So the next important date to watch will be May 26 when the FDA will decide to approve eteplirsen or not.
The stock fell on April 26 after FDA rejected the approval of Duchenne muscular dystrophy (DMD) candidate etiplirsen. One of the main reasons was the small sample size of 12 patients and the trial was not placebo-controlled. The DMD community was strongly in favour of the present environment. But there are still hopes as emotional meeting was held at a hotel in Hyattsville, Maryland wherein hundreds of patients and doctors urged the US FDA to approve the drug since the patients had benefitted Sarepta’s eteplisren. The panel had voted 7-3 with three abstentions saying that the clinical trial of 12 patients did not provide substantial evidence that the drug is effective. The subsequent meeting was also attended by Dr.Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research also made supportive comments with regard to the drug after hearing patient and doctors views.
Duchenne is a rare genetic disorder which is caused by a lack of dystrophin which is a protein to keep muscles healthy. Eteplirsen is expected to increase the production of dystrophin. Its occurance is 1 in 3600 male and there is no drug to treat this disease.
The FDA had similarly rejected BioMarin Pharmaceutical Inc (NASDAQ:BMRN) drug Kyndrisa in the month of January 2016.
A lot of analysts have differing view on Sarepta. Oppenheimer raised the price target of the stock to $ 60. Oppenheimer believes if eteplirsen is approved that itself could add $ 32 a share based on revenue potential through 2030. Jefferies downgraded the stock to sell with a $ 7 price target and they see little chance that the drug will be approved.
Incase the drug gets approved later this month the stock is expected to shoot higher as the expected revenue from eteplirsen is very high but incase the drug doesn’t get approved the stock is expected to fall. The company in that case would have to partner with a big pharmaceuticals company or do the placebo controlled study by raising more equity. The company’s other pipeline drugs for approvals are in early stages of approval so a lot depends on eteplirsen. The DMD community will also watch the FDA findings closely.
About Sarepta Therapeutics:
Sarepta Therapeutics is a biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare, infectious and other diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates, including its lead DMD product candidate, eteplirsen, designed to skip exon 51. Sarepta is also developing therapeutics for the treatment of rare, infectious and other diseases.
Source: Inside Stock Trader & ACAD Charts
Broad street alerts has not been compensated for the mention of any publicly traded companies in this article nor do we own positions in any of the companies in this article.