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BRIEF-Protalix announces FDA investigational new drug clearance commence once-monthly dosing study of pegunigalsidase
May 9, 2017 / 11:48 AM / 6 months ago

BRIEF-Protalix announces FDA investigational new drug clearance commence once-monthly dosing study of pegunigalsidase

May 9 (Reuters) - Protalix Biotherapeutics Inc:

* Protalix announces FDA investigational new drug clearance to commence once-monthly dosing study of pegunigalsidase alfa (prx-102) for the treatment of fabry disease

* Protalix Biotherapeutics Inc- study planned to commence in Q3 of 2017

* Says study planned to commence in Q3 of 2017

* Says plans to enroll up to 30 fabry patients currently treated with an approved enzyme replacement therapy

* Says safety and efficacy evaluation will occur at twelve months with additional long term follow-up Source text for Eikon: Further company coverage:

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