Protalix BioTherapeutics, Inc. (PLX) said the U.S. Food and Drug Administration has accepted its resubmitted new drug application for its experimental drug for Gaucher's disease, a rare genetic ailment.
Protalix shares were up 4.8% at $5.01 in recent premarket trading. The stock through Tuesday's close is down 52% this year.
The U.S. regulator in February had requested more data on clinical trials and on chemistry, manufacturing and controls for the experimental treatment, information the company at that time said it didn't have when it first submitted the new drug application.
Protalix on Wednesday said the new submission addresses the FDA's questions, including its request for clinical data from the company's switchover trial and long-term extension trial.
Gaucher's disease affects one of 20,000 live births and causes a fatty substance to develop in cells in the liver, spleen and bone marrow. Protalix is developing the product with Pfizer Inc. (PFE). The pharmaceutical giant's shares were up 7 cents at $18.38 in recent premarket trading.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481; Tess.Stynes@dowjones.com