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confidence medium
sentiment neutral
materiality 0.60
AEON Biopharma plans biosimilar development of ABP-450 targeting BOTOX; FDA meeting set for Q3 2024
AEON Biopharma, Inc.
- ABP-450 will be developed as a biosimilar using BOTOX as reference product under 351(k) pathway.
- Biosimilar initial advisory meeting with FDA scheduled for Q3 2024.
- Planned Phase 3 cervical dystonia study of ~400 patients to compare ABP-450 to BOTOX.
- No specific financial results for Q2 2024 were disclosed in the press release.
- Company notes development is subject to securing funding.