other material
confidence high
sentiment neutral
materiality 0.65
BioMarin reports phase 3 BMN 270 patient diagnosed with leukemia; initial tests find no link to therapy
BIOMARIN PHARMACEUTICAL INC
- BMN 270 phase 3 participant diagnosed with B-ALL; 85% of leukemic cells had Ph-like translocation.
- BMN 270 vector DNA in leukemic cells was negligible (<1 copy per 500 cells), suggesting no clonal expansion.
- No trial hold; all BMN 270 studies continue enrollment; DSMB agreed no modification needed.
- BioMarin remains on track to resubmit BMN 270 BLA to FDA by end of September 2022.