Name in SEC filings: BIOMARIN PHARMACEUTICAL INC
| Program | Event | Stage | Stated timing | Filing |
|---|---|---|---|---|
| vosoritide | target date (company stated) | PDUFA | February 28, 2027 | SEC filing · |
| BMN 333 | /data readout | Other | 2027 | 8-K · |
Source: ORION, orionbiotechai.com/company/BMRN, data as of Oct 18, 2026
https://www.orionbiotechai.com/company/BMRN
vosoritide · PDUFA target date (company stated) · February 28, 2027
SEC sources last checked .
○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.
children with achondroplasia; full approval application
PDUFA target date (company stated)February 28, 2027
Stage: PDUFASEC filing · “PDUFA) target action date”
Public float: $6,700,000,000 · as of · SEC filing
Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027
SEC filing · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-02)
Topline/data readout2027
Stage: OtherSEC filing · “Phase 2/3”
Public float: $6,700,000,000 · as of · SEC filing
The Phase 2/3 study is enrolling, with a data update expected in 2027.
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-12)
Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .
| Program / event | Stated period and SEC wording | Disclosure in stated period |
|---|---|---|
| BMN 333Clinical results | 2027“The Phase 2/3 study is enrolling, with a data update expected in 2027.” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
| vosoritideFDA decision | February 28, 2027“Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| vosoritideFDA decision | February 28, 2027“Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| BMN 333Clinical results | 2027“A data update from this study is expected in 2027.” Filed · EX-99.1 | Period not started The stated period has not started yet, so there is nothing to compare. |
“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.
Historical summaries and source dates are retained separately from the SEC timing quotes above. Earlier publications were collected retrospectively.
Historical catalog checked .
Source published · Original announcement
Retained timing label: March 31, 2023; potential three-month extension disclosed
Retained summary: BioMarin reported a March 31, 2023 FDA target action date and explicitly said a three-month extension was possible if FDA considered it necessary. The date was a review target, not a promise of approval.
Source published · Original announcement
Retained timing label: 2023-06-30
Retained summary: BioMarin reported that FDA had extended the review in March and set June 30, 2023 as the new target. The company said the requested three-year study analysis constituted a major amendment. This source does not identify the exact day in March when the change occurred.
Source published · Original announcement
Retained summary: BioMarin announced FDA approval of ROCTAVIAN for eligible adults with severe hemophilia A on June 29, 2023. The announcement contains eligibility and safety information; approval should not be read as suitable treatment for every patient.
Original ClinicalTrials.gov record · Open the selected study
These are selected linked records and dated source metadata, not a live registry recheck or the company’s full pipeline. Company announcements and the selected registry study are separate evidence sets. No stage or event timing is borrowed between them.
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See BMRN in the calendar · Review labels and methodology