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Why Sarepta Therapeutics Surged 20% in Wednesday Trading?

Sarepta Therapeutics, Inc.’s SRPT shares soared 19.3% after an equity research analyst at Oppenheimer upped the price target for the stock to $60 from $45. This signifies a massive upside potential, given that Sarepta’s stock closed at $23.30 in Wednesday’s trading (Apr 6).

The raised price target was triggered by expectations of a favorable outcome of the FDA advisory panel meeting later this month followed by an approval for Sarepta’s experimental Duchenne muscular dystrophy (DMD) candidate, eteplirsen.

Sarepta is looking to get eteplirsen approved for the treatment of DMD in patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 51 skipping therapy.

Hectic Last 3 Months

The last three months have been anything but calm for Sarepta. In Jan 2016, the briefing documents that were released ahead of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee meeting were found to be unfavorable with the FDA raising concerns about eteplirsen’s efficacy. The FDA panel was supposed to review the new drug application (NDA) for eteplirsen on Jan 22. The meeting, however, was deferred due to rough weather.

In Feb 2016, the FDA pushed out the review period of eteplirsen further by three months. The regulatory agency said that with the company submitting a major amendment to the NDA in Jan 2016, it needed extra time to complete its review of the submission. The amendment included an additional six-minute walk test and loss of ambulation data compared to a historical control of four-year clinical effectiveness data.

Finally, in Mar 2016, good news flowed in for Sarepta. The company announced that the FDA panel will review the company’s NDA for eteplirsen on Apr 25.

The regulatory agency is expected to announce its verdict by May 26, instead of Feb 26.

The Target Market

DMD, a devastating and an incurable muscle-wasting disease, is estimated to affect nearly 1 in every 3,500–5,000 boys born across the world. Given the lack of FDA-approved DMD treatments, there is significant unmet need for drugs addressing this disease. If approved, 13% of the total patient population with the disease having mutations is addressable by eteplirsen /exon 51 skipping.

We remind investors that companies seeking approval for DMD treatments found little favor with the FDA. BioMarin Pharmaceutical Inc. BMRN received a complete response letter from the FDA for its experimental DMD treatment Kyndrisa this January while the regulatory agency issued a refuse to file letter for PTC Therapeutics, Inc.’s PTCT Translarna in February.

In such a scenario, investor focus is expected to remain on the much awaited outcome of the upcoming advisory panel meeting and the approval status of eteplirsen.

Sarepta is a Zacks Rank #3 (Hold) stock. Anika Therapeutics Inc. ANIK is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).

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BIOMARIN PHARMA (BMRN): Free Stock Analysis Report
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SAREPTA THERAP (SRPT): Free Stock Analysis Report
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