BioMarin Eyes Late 2021 Launch As Achondroplasia Drug Succeeds In Phase III
R&D president Hank Fuchs said vosoritide can be filed based on height gains for children and safety in babies and toddlers with the most common form of dwarfism, but timing depends on meetings with regulators.
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BioMarin Pharmaceuticals has raised expectations for its dwarfism product BMN-111 (vosoritide) on the back of strong Phase II data.
Poseida, Nkarta and Inventiva raised $224m, $252m and $107.7m, respectively. Also, Forbion raised €185m ($208m) of a new €250m fund and Blackstone closed the last $1.2bn of its $4.6bn fund for public and private company deals, and Ascendis led recent follow-ons with a $569.2m offering.
Some analysts see a 50-50 chance of US FDA approval despite the controversial dataset for the anti-amyloid antibody, but at least one expects an eventual CRL requesting a third Phase III trial.