Leerink Keeps BioMarin (BMRN) at 'Outperform' Amid EMA Validation of Brineura MAA
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BioMarin Pharma's (BMRN) MAA for Brineura in CLN2 Disease Validated by EMA
September 15, 2016 8:42 AM EDTBioMarin Pharmaceutical Inc. (Nasdaq : BMRN) announced that the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for Brineura (cerliponase alfa) to treat children with CLN2 disease, a form of Batten disease. Validation of the MAA confirms that the submission is accepted and starts the formal review process by the EMA's Committee for Human Medicinal Products (CHMP).
Earlier this year, the CHMP accepted BioMarin's request for accelerated assessment of the MAA on the grounds that Brineura is of major public health interest with the potential to have a major impact on medical... More