The company said it intends to request the committee
for a re-examination. It was seeking a so-called conditional
approval, granted to treatments that show early benefit. The
drugmaker still needs to conduct trials.
The drug, ataluren, is intended to treat a form of Duchenne muscular
dystrophy which occurs due to a type of genetic mutation known as a
PTC Therapeutics joins a list of companies struggling with
regulatory setbacks to their Duchenne muscular dystrophy drug
programs. Sarepta Therapeutics Inc and Prosensa Holding NV recently
faced U.S. regulatory setbacks.
PTC Therapeutics shares closed at $26.22 on Thursday on the Nasdaq.
(Reporting by Vrinda Manocha in
Bangalore; editing by Don Sebastian)
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