10:41 AM EDT, 10/29/2025 (MT Newswires) -- BioMarin Pharmaceutical ( BMRN ) said Wednesday the US Food and Drug Administration accepted for priority review its supplemental biologics license application for Palynziq (pegvaliase-pqpz), seeking to extend its use to adolescents aged 12 to 17 with phenylketonuria.

The FDA set a Prescription Drug User Fee Act target action date of Feb. 28, 2026, the company said.

BioMarin said the filing is supported by data from the phase 3 Pegasus study, which showed that Palynziq lowered blood phenylalanine levels compared with diet alone and allowed greater dietary protein intake.

The company said it also plans to submit the data to the European Medicines Agency for a similar expansion in the European Union. Palynziq remains the only approved enzyme substitution therapy for adults with phenylketonuria, it added.

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