BioMarin Announces Decision to Start Phase 3 Program for PEG-PAL; Says Phase 2 Meeting with FDA in Q1, Drug Generally Well-Tolerated in Phase 2
BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today preliminary results from the Phase 2 program of PEG-PAL (PEGylated recombinant Phenylalanine Ammonia Lyase) for the treatment of phenylketonuria (PKU) demonstrating long-term retention, tolerability and providing evidence of efficacy. Based on these results, the company expects to start a pivotal Phase 3 study in the second quarter of 2013, following an anticipated end of Phase 2 meeting with the FDA in the first quarter of 2013.
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