Sarepta Therapeutics said the U.S. Food and Drug Administration has requested for additional data from an ongoing study for its muscle-wasting treatment as the agency decides whether to approve the drug or not.
Shares of the company soared more than 40 percent in premarket trading on Tuesday as investors pinned hopes on a possible approval. (Get the latest quote here.)
Analysts at Wedbush Securities upgraded the stock to "outperform" from "neutral," and raised their price target to $36 from $14 after the announcement.
"We believe there is a good chance these data will demonstrate required dystrophin production and recommend shares ahead of a regulatory decision, which could come in 2016," they said in a Monday note to clients.
The FDA deferred a highly anticipated decision on whether to approve Sarepta's drug, eteplirsen, last month, after an advisory panel determined that the treatment was not effective.
The agency requested that Sarepta provide dystrophin data from biopsies already obtained from the ongoing confirmatory study of eteplirsen, the company said on Monday.