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