Yahoo Finance PTC Therapeutics surges on EU panel opinion
PTC Therapeutics climbs after EU advisory panel recommends conditional approval for Translarna
NEW YORK (AP) -- Shares of PTC Therapeutics surged Friday after the company's drug Translarna moved closer to approval in the European Union.
A panel that advises the EU's drug and medical device agency said it believes Translarna should get conditional marketing approval. The drug is designed to treat a type of Duchenne muscular dystrophy, a rare and fatal genetic disease.
The South Plainfield, New Jersey-based company expects a ruling within three months.
Shares of PTC Therapeutics Inc., which does not have any approved drugs, gained $4.98, or 33 percent, to $21.30 in afternoon trading.
In January the panel had said it was opposed to conditional approval of the drug, but PTC Therapeutics asked the agency to reconsider.
If Translarna gets conditional approval, PTC Therapeutics will still have to complete clinical studies of the drug. The conditional approval must be renewed annually until full approval is granted.
The company is running a late-stage clinical trial and expects to get initial results from it in mid-2015. It plans to file for approval in the U.S. when it finishes that study.
Translarna is designed to treat cases of Duchenne muscular dystrophy caused by a particular type of genetic mutation. PTC says about 2,000 patients in the U.S. and 2,500 in the EU have that mutation.
