Protalix Biotherapeutics Inc (NYSE:PLX) shares had already been on a solid 3% bump yesterday and in pre-market trading have gone on to race up another close to 7% amid the news of an exciting victory: the Israeli pharma firm's Fabry disease asset PRX-102 gained favor from the European Commission by granting of an Orphan Drug Designation (ODD). Should this orphan drug designation be maintained when the Fabry disease candidate garners approval for marketing in the European Union (EU), this could translate to an advantage of ten years of market exclusivity for Protalix within the EU.
For context, the company has designed its PRX-102 asset, or pegunigalsidase alfa, as a plant cell culture expressed, and a chemically modified version of the recombinant alpha-Galactosidase-A protein, aimed to treat Fabry disease that afflicts one person out of every 40,000. Fabry disease, an X-linked inherited condition that results from abnormal deposits of a fatty substance called globotriaosylceramide in blood vessel walls throughout a person's body, usually requires bi-weekly infusions, whereas Protalix's treatment could enable an option of just once-monthly infusions, with hopes of improved clinical efficacy and an enhanced safety profile.
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The decision by the Commission confirms the opinion previously issued by the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products (COMP), which the PLX team announced on November 13, 2017. Orphan drug designation for pegunigalsidase alfa qualifies the sponsor for access to the centralized marketing authorization procedure, including applications for inspections and for protocol assistance.
PLX has a 1-year high of $1.51 and a 1-year low of $0.35. The stock's 50-day moving average is $0.67 and its 200-day moving average is $0.68.
On the ratings front, H.C. Wainwright analyst Ram Selvaraju reiterated a Buy rating on PLX, with a price target of $5, in a report issued on November 29. The current price target represents a potential upside of 658% from where the stock is currently trading.
According to TipRanks.com, Selvaraju has a yearly average loss of 17.7%, a 29% success rate, and is ranked #4678 out of 4726 analysts.
Protalix Biotherapeutics, Inc. engages in the development and commercialization of recombinant therapeutic proteins based on ProCellEx plant cell based expression system. It offers Taliglucerase alfa injections under the brand name Elelyso, an enzyme replacement therapy for Gaucher disease. The company's drug also include Oral Glucocerebrosidase for potential treatment of Gaucher disease; therapeutic proteins for Fabry disease, and immune diseases such as rheumatoid, psoriatic and juvenile idiopathic arthritis, ankylosing, spondylitis, and plaque psoriasis; and protein for biodefense and other indications.
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