U.S. FDA Approves BioMarin's BRINEURA For Children Under 3 Years With CLN2 Disease
Portfolio Pulse from Benzinga Newsdesk
The U.S. FDA has approved BioMarin Pharmaceutical Inc.'s (NASDAQ:BMRN) supplemental Biologics License Application for BRINEURA to treat children of all ages with CLN2 disease, regardless of symptom presence. This expands the previous indication which was limited to symptomatic children aged 3 years and older.
July 24, 2024 | 8:25 pm
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BioMarin Pharmaceutical Inc. received FDA approval for an expanded indication of BRINEURA, now approved for children of all ages with CLN2 disease. This regulatory milestone could enhance the company's market position and revenue potential.
The FDA approval for an expanded indication of BRINEURA significantly broadens the potential patient base, which could lead to increased sales and revenue for BioMarin. This regulatory milestone is likely to positively impact the stock price in the short term.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100