NEW YORK (TheStreet) -- Sarepta Therapeutics (SRPT) soared Monday after the company announced it had received FDA guidance to apply for regulatory approval of its experimental Duchenne muscular dystrophy drug eteplirsen by the end of the year.
The application would lead to a clinical study on a larger scale.
The company said in a statement it would bolster its FDA application with more safety and efficacy data from an earlier trial of the drug, along with a confirmatory study it plans to begin in the third quarter.
The FDA said in November that Sarepta's plan to file based on data at the time was premature, which caused a 64% drop in the stock in just one day.Sarepta was up more than 47% to $35.98 at 11:30 a.m., by which point it had easily surpassed its average volume of 1,290,500 with nearly 9 million shares traded for the day. The stock hit a high of $44.60 as of that time. Must Read: Warren Buffett's 10 Favorite Growth Stocks STOCKS TO BUY: TheStreet Quant Ratings has identified a handful of stocks that can potentially TRIPLE in the next 12 months. Learn more. STOCKS TO BUY: TheStreet Quant Ratings has identified a handful of stocks that can potentially TRIPLE in the next 12 months. Learn more.
Check Out Our Best Services for Investors
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Model portfolio
- Stocks trading below $10
- Intraday trade alerts