NEW YORK (TheStreet) -- Shares of Sarepta Therapeutics (SRPT) - Get Report are soaring 25% to $23.05 on heavy trading volume late Wednesday afternoon after the FDA delayed a decision on whether to approve its Duchenne muscular dystrophy (DMD) treatment, eteplirsen.
The decision was due on Thursday, and the market is interpreting the postponement as a positive development.
If approved, the drug will be the only DMD treatment on the market.
"Today's news is a clear incremental positive for Sarepta: not only was the worst case scenario, i.e. a CRL averted, but this extension by FDA, which appears open-ended and not the standard 3-month type, buys more time for the company's supporters and the DMD patient community to exert additional pressure to FDA," RBC Capital contended, Barron's reports.
But the firm "continues to see only a small chance of approval" given the FDA's analysis of the data and the precedent that a possible approval would set.
Leerink is similarly cautious about the FDA decision, noting that eteplirsen is likely being carried more so by intangible factors such as pressure from advocates and politicians rather than by science and data on which the FDA is likely to base its eventual decision.
About 18.76 million shares of Sarepta have been traded so far today, well above the company's average trading volume of roughly 9.73 million shares per day.
Separately, TheStreet Ratings team rates the stock as a "sell" with a ratings score of D-.
Sarepta's weaknesses include its disappointing return on equity, weak operating cash flow and poor profit margins.
You can view the full analysis from the report here: SRPT
TheStreet Ratings objectively rated this stock according to its "risk-adjusted" total return prospect over a 12-month investment horizon. Not based on the news in any given day, the rating may differ from Jim Cramer's view or that of this article's author.