Back to top

Analyst Blog

Sarepta Therapeutics, Inc. (SRPT - Analyst Report) reported results through week 144 from a phase IIb study (Study 202: a long-term open-label extension study) on its lead candidate, eteplirsen, being developed for the treatment of Duchenne muscular dystrophy (DMD).

Sarepta’s shares tumbled 12.9% following the news. The study’s 144 week data was comparatively weaker than the 120 week data reported in Jan 2014.

Results from the study through 144 weeks revealed that patients under eteplirsen cohorts (30 mg/kg and 50 mg/kg) being able to perform a 6-minute walk test experienced a decline of 33.2 meters from baseline in walking ability. However, a statistically significant benefit of 75.1 meters was observed in modified Intent-to-Treat (mITT) population (n=6) compared with the placebo/delayed-treatment cohort (n=4), who started treatment with eteplirsen at week 25 after 24 weeks of placebo treatment.

Meanwhile, Sarepta’s previously reported 120-week data showed that patients under eteplirsen cohorts experienced a decline of 13.9 meters from baseline in walking ability as against a statistically significant benefit of 64.9 meters in mITT population compared with the placebo/delayed-treatment cohort, who started treatment with eteplirsen at week 25 after 24 weeks of placebo therapy.

Sarepta shares had soared over 39% earlier this year after it announced that it would submit a New Drug Application (NDA) to the FDA for eteplirsen in the DMD indication by year end. Sarepta’s decision on the filing of regulatory application for eteplirsen was based on a guidance letter from the FDA. In Nov 2013, the FDA had stated that the NDA filing of eteplirsen would be premature at that time. The company met with the FDA several times before receiving the guidance letter.

The company maintained its stance that it will be filling for eteplirsen by year end. However, we remain concerned about the relatively weaker results at week 144 compared to that of week 120. Sarepta shares may drop further if any other disappointing news on its lead candidate emerges.

Sarepta Therapeutics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Actelion Ltd. (ALIOF), The Medicines Company (MDCO - Analyst Report) and Synergy Pharmaceuticals, Inc. (SGYP - Snapshot Report). All three stocks carry a Zacks Rank #1 (Strong Buy).

Please login to Zacks.com or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research

Close

Are you a new Zacks Member or a visitor to Zacks.com?

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Zacks.com. Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
RPC INC RES 24.91 +8.35%
LITHIA MOTO… LAD 94.59 +4.60%
DELTA AIR L… DAL 39.15 +3.90%
FLAMEL TECH… FLML 14.51 +3.50%
SOUTHWEST A… LUV 28.87 +2.92%