* Drug being developed to treat Duchenne muscular dystrophy
* Prosensa to conduct two post-approval studies
* Application for U.S. marketing approval later this year
* Shares rise 5 pct in premarket trading
(Adds details; updates shares)
June 3 (Reuters) - Prosensa Holding NV said the U.S. health regulator had outlined an accelerated regulatory approval path for its most advanced drug, aimed at treating a muscle disorder, sending the company's shares up 5 percent in premarket trading.
The drug, drisapersen, is being developed to treat Duchenne muscular dystrophy (DMD), a muscle-wasting disorder that affects one in every 3,500 newborn boys.
The Netherlands-based company said on Tuesday it planned to conduct two post-approval studies and file a marketing application in the United States later this year.
Prosensa also said it would file for European approval in the near future.
Accelerated approval is usually granted to drugs for serious diseases with no treatment options, based on data from initial trials. However, a company still needs to conduct larger trials to bolster its initial findings.
Other DMD drugs-in-development have also seen encouraging regulatory action in recent months.
European regulators recommended a conditional approval for PTC Therapeutics Inc's Translarna last month.
In April, the U.S. Food and Drug Administration indicated an alternate path for approval to Sarepta Therapeutics Inc's eteplirsen.
Drisapersen, like eteplirsen, is designed to enhance the production of a protein called dystrophin, the lack of which causes DMD.
Prosensa said in January that it would pursue the development of drisapersen despite its failure in a late-stage trial, after additional data showed its use could slow disease progression.
Earlier that month, partner GlaxoSmithKline Plc returned the rights to the drug to Prosensa, terminating a 2009 collaboration deal to develop it.
Prosensa's shares closed at $10.59 on the Nasdaq on Monday.
(Reporting by Natalie Grover in Bangalore; Editing by Joyjeet Das and Kirti Pandey)