UPDATE: Wells Fargo Downgrades Protalix BioTherapeutics to Market Peform on EU Challenges for Elelyso

Wells Fargo lowers its rating on Protalix BioTherapeutics (NYSE: PLX) from Outperform to Market Perform on lower estimates due to European regulatory challenges.

Wells Fargo comments, "On 6/22, CHMP announced that they were not recommending approval of Elelyso in Europe despite its favorable clinical benefit, due to Shire's Orphan exclusivity status for Vpriv in that region. This was a known risk, but we had believed that CHMP would make an exception to this technicality given the recent Gaucher enzyme supply issues. Europe is a significant potential market for Elelyso, with nearly 40% of our out-year estimated revenue expected from this region. While this rejection is a non-final decision and the European Commission (EC) could still decide to approve Elelyso, we do not believe this is highly likely, and as such have lowered our probability of European approval to 30%."

PLX closed at $6.19 on Friday.

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