BioMarin Pharmaceuticals

BMRN

Market cap $11.4B

BioMarin's FDA filing for full Voxzogo approval in achondroplasia has been accepted, with a regulatory decision expected by Feb. 28, 2027.

Application based on long-term safety and efficacy data from three ongoing studies, including adult height and additional clinical outcomes beyond linear growth, including body proportionality and arm span evaluated over long-term follow-up FDA PDUFA target action date of Feb. 28, 2027 SAN RAFAEL, Calif., July 13, 2026 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for VOXZOGO ® (vosoritide) for full approval in children with achondroplasia.

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Data from an investigator-led study showed treatment with VOXZOGO resulted in sustained improvements in growth over three years in children with hypochondroplasia New Phase 1 results also presented for investigational BMN 333 support potential weekly dosing in children with achondroplasia SAN RAFAEL, Calif., June 16, 2026 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced new data from studies of VOXZOGO® (vosoritide) in children with hypochondroplasia and the investigational medicine BMN 333 in achondroplasia were presented at ENDO 2026, the Endocrine Society Annual Meeting, in Chicago.

BioMarin (BMRN) reported earnings 30 days ago. What's next for the stock?

BMRN's shares rise after Voxzogo hits the main goal in a late-stage hypochondroplasia study, supporting planned FDA filings in 2026.

BioMarin Pharmaceuticals Inc. (NASDAQ:BMRN) stock is trading higher on Thursday as the company is celebrating positive results from its Phase 3 CANOPY-HCH-3 study for VOXZOGO (vosoritide) in children with hypochondroplasia.

BioMarin Pharmaceutical said on Wednesday its treatment for a rare condition that leads to ​short stature helped boost growth in ‌children, meeting the main goal of a late-stage study and sending shares up nearly 5% in extended ​trading.

Study met primary endpoint, exceeding expectations with a highly statistically significant improvement in annualized growth velocity (AGV, change from baseline) of 2.33 cm/yr compared to placebo at week 52, as well as statistically significant increases in standing height and height Z-score Study demonstrated statistically significant improvement in arm span at week 52 compared to placebo, a key measure linked to functional independence Safety findings consistent with the established profile in achondroplasia with no new safety signals identified Supplemental New Drug Application (sNDA) submission to U.S. Food and Drug Administration (FDA) planned for third quarter, followed by submissions to the European Medicines Agency (EMA) and other regional health authorities  Full data to be presented at an upcoming medical meeting  SAN RAFAEL, Calif., May 20, 2026 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the Phase 3 CANOPY-HCH-3 study evaluating treatment with VOXZOGO ® (vosoritide) in children with hypochondroplasia met its primary endpoint, demonstrating a statistically significant increase in the change from baseline at week 52 in annualized growth velocity (AGV) compared to placebo (LS mean difference +2.33 cm/yr, p

BioMarin shares fall after BMN 401 meets a biomarker goal but misses a key radiographic endpoint in a late-stage ENPP1 deficiency study.