AEON
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Daily updates
- AEON Biopharma received FDA Type 2b feedback supporting a streamlined regulatory pathway for its BOTOX biosimilar candidate ABP-450. Scientific bridging allows prior comparative clinical work to serve as supportive evidence. AEON plans to submit an IND in Q4 2026 for a CMAP pharmacodynamic study in Q1 2027 and may use analytical, PD, and historical clinical data to potentially avoid a dedicated comparative efficacy trial.Oct 1, 2026
- AEON's ABP-450 showed BOTOX-like forced-degradation stability patternsSep 10, 2026
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News
- AEON Biopharma reports FDA Type 2b meeting feedback that clarifies the biosimilar development plan for ABP-450Sep 30, 2026
- AEON reported expanded structural data supporting the molecular similarity of ABP-450 to BOTOXAug 19, 2026
- AEON Biopharma received FDA feedback following a Type 2a meeting for its ABP-450 biosimilar programMar 25, 2026
- AEON Biopharma reports positive and robust biosimilarity results: identical amino acid sequence and highly similar functional analysis dataNov 13, 2025