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Benitec Stock Up on Orphan Drug Status for BB-301 in EU

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Shares of Benitec Biopharma Limited surged 62.2% after the company announced that its proposed candidate, BB-301, has received Orphan Drug Designation in the EU for the treatment of patients with ocularpharyngeal muscular dystrophy (OPMD).

A look at Benitec’s price movement in the past one year shows that the company has underperformed the Medical-Biomedical/Genetics industry. Specifically, the stock declined 23.7%, compared to the industry’s 9.6% fall.



Coming back to the latest news, the designation was backed by a favorable recommendation from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP).

The European Commission usually grants orphan medicinal product status in order to provide incentives to candidates that are being developed to treat, prevent or diagnose diseases or conditions affecting no more than 5 in 10,000 people in the region.

Orphan drug status in the EU provides not only a 10-year period of market exclusivity upon approval, but other benefits as well, including fee waivers, protocol assistance during the product development phase under the centralized procedure valid in all EU countries.

BB-301 is currently in preclinical development. Investigational new drug (IND)-enabling studies are expected to be initiated later this year. Benitec expects to initiate a phase I/II study on BB-301 in OPMD patients in 2018.

With no approved of treatment options for OPMD, the company has significant potential in this market.

Meanwhile, Bioblast Pharma Ltd. is evaluating its own OPMD candidate, trehalose, in phase II development.

Key Picks in the Sector

Investors looking for a couple of favorably placed stocks in this industry may consider Sucampo Pharmaceuticals, Inc. and Anika Therapeutics, Inc. (ANIK - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Sucmapo’s earnings estimates were stable at $1.22 for 2016 but have increased from $1.30 to $1.74 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 35.5%.

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