U.S. Food and Drug Administration Approves BioMarin's PALYNZIQ® (pegvaliase-pqpz) for Adolescents 12 Years of Age and Older with Phenylketonuria (PKU) [Yahoo! Finance]
BioMarin Pharmaceutical Inc. (BMRN)
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Source: Yahoo! Finance
Treatment with PALYNZIQ led to statistically significant blood phenylalanine (Phe) lowering compared to diet alone in pivotal Phase 3 PEGASUS study PALYNZIQ is the only enzyme substitution therapy approved for the treatment of people with PKU SAN RAFAEL, Calif. Feb. 27, 2026 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for PALYNZIQ ® (pegvaliase-pqpz) to include pediatric patients 12 years of age and older with phenylketonuria (PKU). PALYNZIQ is the only enzyme substitution therapy approved to reduce blood phenylalanine (Phe) concentrations in people with PKU. BioMarin Pharmaceutical logo (PRNewsfoto/BioMarin Pharmaceutical Inc.) "Adolescence is a period of increasing independence and academic demands, and represents a particularly challenging time for individuals with PKU. The ultra-restrictive diet required for PKU mana
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BMRN
Earnings
- 2/23/26 - Beat
BMRN
Sec Filings
- 2/26/26 - Form 4
- 2/26/26 - Form 4
- 2/26/26 - Form 4
- BMRN's page on the SEC website