Shares of Protalix BioTherapeutics shot up 30 percent this morning after the developer announced that the FDA had approved the interim use of its experimental therapy for Gaucher's disease.
The FDA had reached out to Protalix, asking the company to submit a treatment protocol for the late-stage therapy prGCD. The approval gives physicians the opportunity to use the therapy--now badly needed--under an expanded access program. A shortage of Genzyme's Cerezyme developed after a virus forced the biotech company to shut down a Boston facility. And it positions Israel's Protalix for a shot at full regulatory approval just as it is wrapping up late-stage studies.
"We expect to conclude our Phase III pivotal study next month and are looking forward to announcing top-line results from this study in October. We anticipate filing an NDA with the FDA by the end of this year," said Protalix Chief Executive David Aviezer.
- check out the Protalix release
- read the report from MarketWatch