This morning we issued a trade alert based on a new 10K that was filed by Protalix BioTherapeutics (AMEX: PLX) after hours on Wednesday.
Within the 10K, investors found the answer to the number one open concern going into this week's pending FDA approval for the PLX/partner Pfizer’s Gaucher's disease enzyme replacement therapy, Uplyso (taliglucerase alfa). The FDA has set a PDUFA date of 25 February 2011 for a decision on the plant-cell expressed therapy candidate.
From the 10-k filing: "On February 20, 2011, we received a letter from the FDA notifying us that the FDA had completed its review of the Establishment Inspection Report in connection with the FDA's inspection of our facility in Carmiel, Israel, and that the FDA had classified our facility as acceptable."
As biotech investors know, the acceptance of a firm's manufacturing facilities are a critical step towards FDA approval of a drug candidate. The fact that U.S. regulators have signed off on the Israeli facility bodes well for Protalix.
Analysts actively covering the sector have been very bullish about the drug candidate's chances in the days and weeks leading up to this point.
Cannacord Genuity’s Ritu Baral had this to say in her latest report issued just a couple of days ago: “We think PLX/partner Pfizer’s taliglucerase (tali) for Gaucher’s will be approved by its Feb. 25 PDUFA date. We expect a strong US launch in Q2/11 driven by EAP patients and Phase 3b data. We think tali will capture ~15+% of the $1.2B+ Gaucher’s market, taking Cerezyme market share through strong marketing and competitive pricing. Our $13 target is based on a pNPV analysis."
In addition, Wells Fargo Market Securities issued this comment along with a $12-$14 "outperform" price target for the company:
"We believe regulatory approval of Protalix’s lead drug taliglucerase, an enzyme replacement therapy for Gaucher disease partnered with Pfizer (PFE) is highly likely, potentially catalyzing upside for the shares in H1 2011. We also believe Protalix has a unique profile among small-cap biotechs, which should command a premium: the potential for sustainable profitability from product sales near term, and an underlying technology platform capable of producing other successful candidates longer term. Although recent share appreciation indicates that the company is no longer below investors’ radars, we believe the stock remains undervalued based on the potential of taliglucerase and the unique protein production platform."
As you can see from the chart below, the stock has been trading within a rising channel since April.
After a breif bear raid this morning, the stock is bouncing back nicely and most of our writing staff is in agreement that an FDA approval could be announced at any moment.
As always, we urge you to do your own due dilligence and to set your stop-losses carefully before any trade.
Disclosure: Long PLX
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