Biomarin Pharmaceutical Inc
9 products tracked · names used in filings: Biomarin Pharmaceutical Inc, BioMarin International Limited
Upcoming milestones
VOXZOGO: PDUFA target action date (hypochondroplasia (HCH))
Biomarin Pharmaceutical Inc (BMRN); sNDA; status: set; "…2026 Total Revenues Increased 32% Y/Y to $1.025 billion; Growth Driven by 44% Increase in Metabolic Conditions Y/Y, and 12% Increase in Skeletal Conditions Y/Y Updates Full-year 2026 Guidance to Reflect Order Timing Uncertainty and Impact of Two Acquired In-process Research and Development (IPR&D) Charges Recently…"; filed 2026-11-02 · source
Recent milestones
PALYNZIQ: PDUFA target action date (adolescent label expansion (PKU))
Biomarin Pharmaceutical Inc (BMRN); empty; status: set; "PDUFA date for the adolescent label expansion February 28, 2026; EU approval 2026 BMN 401: • Phase 3 topline data in 1 to 12 year-old population with ENPP1 deficiency 1H’26; global re"; filed 2026-02-23 · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇪🇺 | Kyndrisa | Application withdrawn | |
| 🇪🇺 | Roctavian valoctocogene roxaparvovec | Application withdrawn | |
| 🇪🇺 | Roctavian valoctocogene roxaparvovec | Authorised | 2022-08-24 |
| 🇪🇺 | Voxzogo vosoritide | Authorised | 2021-08-26 |
| 🇪🇺 | Palynziq pegvaliase | Authorised | 2019-05-03 |
| 🇪🇺 | Brineura cerliponase alfa | Authorised | 2017-05-30 |
| 🇪🇺 | Vimizim elosulfase alfa | Authorised | 2014-04-27 |
| 🇪🇺 | Kuvan sapropterin | Authorised | 2008-12-02 |
| 🇪🇺 | Naglazyme galsulfase | Authorised | 2006-01-23 |
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.