Why Protalix BioTherapeutics Stock Is Plunging Today
Shares of Protalix BioTherapeutics (NYSEMKT: PLX) are falling off a cliff on Wednesday after the company announced a disappointing regulatory update regarding one of its pipeline candidates, pegunigalsidase alfa (PRX-102). The biopharmaceutical company's stock was down by 38.4% as of 12:41 p.m. EDT, after dropping by as much as 43.2% earlier in the day.
Pegunigalsidase alfa is an experimental treatment for a rare genetic disorder called Fabry disease. Protalix BioTherapeutics is developing this therapy in collaboration with privately owned Chiesi Global Rare Diseases. Today, the two entities reported that they had received a complete response letter from the U.S. Food and Drug Administration (FDA) for their biologics license application for pegunigalsidase alfa as a treatment for Fabry disease in adult patients.
The FDA sends a complete response letter to communicate it has completed its review of a new or generic drug application, and it decided that it will not approve it for marketing in its present form.
Source Fool.com
