Catalyst reports FDA approval of AGAMREE for DMD; expects Q1 2024 launch

CATALYST PHARMACEUTICALS, INC.

Santhera received FDA approval for AGAMREE (vamorolone) oral suspension 40 mg/mL for DMD in patients aged 2+.
Catalyst holds exclusive North American license; NDA transfer from Santhera to Catalyst is prompt.
Catalyst expects to commercially launch AGAMREE in Q1 2024 with a patient assistance program.
AGAMREE has orphan drug exclusivity (7 years) and patent protection potentially until 2040.
Approval based on Phase 2b VISION-DMD study and open-label extension data up to 48 months.

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