IndustryCompany release

BioMarin third-quarter revenue rises 32% to $1.025bn as Amicus assets contribute

🇺🇸 Biomarin Pharmaceutical Inc (BMRN) · Mon 02 Nov 2026

BioMarin reported a GAAP net loss of $123m for Q3 2026, revised full-year guidance, and gained FDA and EMA milestones for Voxzogo in hypochondroplasia and achondroplasia.

BioMarin Pharmaceutical reported third-quarter 2026 results on 2 November, with revenue of $1.025bn, up 32%. The company attributed the growth to Galafold and Pombiliti + Opfolda, products it gained through the Amicus acquisition. It posted a GAAP net loss of $123m for the quarter.

The company also updated its full-year 2026 guidance. According to the summary of the announcement, the changes reflect the timing of orders and two acquired in-process research and development (IPR&D) charges. No further detail on the revised figures was available to VigiEye at the time of writing.

On the regulatory front, the US Food and Drug Administration has set a PDUFA goal date of 30 May 2027 for Voxzogo (vosoritide) in hypochondroplasia. The European Medicines Agency has validated the corresponding filing, which allows scientific assessment to begin. A PDUFA date is the target by which the FDA aims to complete its review of an application.

Separately, a goal date of 28 February 2027 applies to the FDA decision on full approval of Voxzogo in achondroplasia.

What it means for your team

  • Regulatory teams should note the two FDA dates: 28 February 2027 for full approval in achondroplasia and 30 May 2027 for hypochondroplasia.
  • EMA validation of the hypochondroplasia filing means the centralised assessment is now under way, though no EU timetable was given in the material available.
  • Market-access teams tracking rare-disease portfolios can see that Galafold and Pombiliti + Opfolda are now significant revenue contributors for BioMarin following the Amicus deal.

Company's press release (SEC filing): Biomarin Pharmaceutical Inc ↗

Article written by VigiEye from the official source (Biomarin Pharmaceutical Inc). Claims are the company's own. AI-assisted; check the source before acting.

More Industry All →