Shares of Israel's Protalix Biotherapeutics slid 14 percent after the FDA bounced back its marketing application for a new Gaucher disease drug with a request for more information. The agency had some follow-up questions that focus on the manufacturing process, Protalix said in a release, and had not asked for more clinical or preclinical input.
Protalix (PLX) hastened to assure investors--who bid up the company stock as Genzyme floundered last year after it was forced to halt production of Cerezyme--that they could get the agency's questions answered in the second quarter. Genzyme reaps about $200,000 for a year's supply of Cerezyme.
At the end of January Protalix shares were fueled by a report that its drug--taliglucerase--was better than Cerezyme in penetrating the target cells. It also didn't hurt that Halman Aldubi began coverage of the company with a boldly bullish assessment that its shares could almost double in value in February. Earlier today, though, investors were of a different mindset, as Protalix's shares were trading down at around $6.07.
- check out the Protalix release
- here's the Reuters story