NetworkNewsBreaks – Benitec (NASDAQ: BNTC) Shares Surge on Orphan Drug Designation for BB-301 in the EU
Benitec Biopharma (NASDAQ: BNTC; BNTCW) is trading 71% higher on news that the company’s BB-301 for the treatment of patients with oculopharyngeal muscular dystrophy (OPMD) has been granted Orphan Drug Designation by the European Commission. The designation, which provides regulatory and financial incentives including a 10-year period of marketing exclusivity in the EU after product approval and protocol assistance from the European Medicines Agency (EMA) during the product development phase, was based on favorable recommendation from the EMA Committee for Orphan Medicinal Products (COMP). Entry into the clinic with a phase I/II study in OPMD patients is anticipated in 2018,…







