Sarepta Therapeutics, Inc. SRPT came up with two important corporate announcements – completion of a rolling submission of the new drug application (NDA) for eteplirsen and securing $40 million in debt financing.
Eteplirsen Regulatory Filing Completed
Sarepta announced the completion of the rolling submission of an NDA for its Duchenne muscular dystrophy (DMD) candidate, eteplirsen, to the FDA. The rolling NDA submission which began on May 20 immediately following the completion of the pre-NDA meeting with the FDA the day before was completed on Jun 26, 2015.
Sarepta is seeking priority review, which could shorten the review period from the standard 10 months to just 6 months. We note that eteplirsen already enjoys Fast Track and orphan status in the U.S.
Eteplirsen is the company’s lead pipeline candidate. DMD, a devastating and debilitating disease, is estimated to affect nearly 1 in every 3,500 boys born across the world. There is significant unmet need for DMD treatments. Once successfully developed and approved, eteplirsen has the potential to address up to 13% of the total DMD population.
The NDA submission, however, puts Sarepta about two months behind BioMarin BMRN, which completed filing for its DMD candidate, drisapersen, at the end of April. Meanwhile, BioMarin announced that the FDA has granted priority review to drisapersen with an FDA action date of Dec 27, 2015. BioMarin could have a head start if approval comes on schedule. With the FDA informing BioMarin that its regulatory application will come up before an advisory panel, chances are high that eteplirsen will also be reviewed by an FDA advisory panel.
Procures $40M Debt Financing
In concurrence with the completed eteplirsen NDA submission, Sarepta entered into a credit and security agreement with Midcap Financial to procure up to $40 million in debt financing. The senior secured term loan facility which matures in Jun 2018 carries an annual interest rate of 7.75%. Sarepta informed that it has already raised $20 million under the facility.
Sarepta currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Gilead Sciences Inc. GILD and Hospira Inc. HSP. Both hold a Zacks Rank #1 (Strong Buy).
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