BioMarin plans FDA filing in Q3 2026 for Voxzogo in hypochondroplasia

Biomarin

Biomarin

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  • BioMarin plans to file a supplemental NDA with the FDA in Q3 2026 to expand VOXZOGO’s label to children with hypochondroplasia, following positive Phase 3 data.
  • The CANOPY-HCH-3 trial met its primary endpoint, showing a 2.33 cm/year improvement in annualized growth velocity versus placebo at week 52.
  • Submissions to the EMA and other regulators are expected to follow.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioMarin Pharmaceutical Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202605201620PR_NEWS_USPR_____SF64695) on May 20, 2026, and is solely responsible for the information contained therein.