Early on Monday morning, the company announced the completion of the rolling submission of a NDA to the U.S. Food and Drug Administration (FDA) for eteplirsen.
Eteplirsen targets the underlying cause of Duchenne muscular dystrophy and is designed to enable the production of a functional internally truncated dystrophin protein in patients with mutations amenable to exon 51 skipping. Roughly 13% of people with Duchenne muscular dystrophy are estimated to have a mutation targeted by eteplirsen/exon 51 skipping.
Edward M. Kaye, interim CEO and chief medical officer of Sarepta, commented on the study:
The completion of our NDA submission for eteplirsen represents the culmination of the efforts of our employees, investigators, clinical trial sites, and most importantly the patients and families of the Duchenne community. We look forward to working with the FDA during the regulatory process in pursuit of our goal of bringing eteplirsen to patients amenable to exon 51 skipping, while maintaining our organizational focus on advancing our PMO technology to target other DMD subpopulations amenable to exon-skipping as quickly as possible.
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At the same time, Sarepta secured $40 million in debt financing from Micap Financial. The firm established a senior secured term loan facility that allows Sarepta to borrow up to $40 million at an annual rate of 7.75%, with a maturity of June 2018. So far, Sarepta has drawn down $20 million under the facility and has the right to repay all borrowed funds and terminate the facility at any time.
So far Sarepta has posted an incredible performance for the year, as shares are up 116%.
Shares of Sarepta were down nearly 10% at $28.29 on Monday afternoon. The stock has a consensus analyst price target of $30.36 and a 52-week trading range of $11.33 to $33.16.
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