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UPDATE - Auriga Downgraded Protalix BioTherapeutics (PLX) to Hold; Odds of FDA Approval Are Difficult to Gauge

April 30, 2012 10:51 AM EDT
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Price: $2.38 --0%

Rating Summary:
    3 Buy, 5 Hold, 0 Sell

Rating Trend: = Flat

Today's Overall Ratings:
    Up: 8 | Down: 5 | New: 26
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UPDATE - Auriga downgraded Protalix BioTherapeutics (NYSE: PLX) from Buy to Hold with a price target of $8.00.

Analyst, Difei Yound, said, "We have observed pre-approval run-up on PLX and now the share price is at a level where we believe the risk/reward is no longer favorable. Betting on FDA's decision in particular with regards to questions on CMC (Chemistry, Manufacturing and Control) is risky as much of the information is not publically available; they are mostly communications between the FDA and the company. We believe Taliglucerase will eventually be approved. However, we are less certain about the timing. We therefore advise clients to take profit and stay on the sideline in anticipation of the PDUFA event on May 1, 2012. Odds of FDA approval are difficult to gauge. This is the second time that Protalix goes before the FDA for approval on Taliglucerase. FDA issued a Complete Response Letter last time. So on the positive side, The FDA has already allowed Protalix and Pfizer to treat Gaucher's patients under a compassionate use program so the drug's efficacy and safety are not an issue."

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