AEON Biopharma Q3 2024: FDA aligned on biosimilar path for ABP-450, but capital constraints persist

AEON Biopharma, Inc.

Held Biosimilar Initial Advisory meeting with FDA in Q3; aligned on 351(k) pathway using BOTOX as reference.
Primary comparative analytical studies planned for Q4 2024, subject to securing capital resources.
BPD Type 2 meeting with FDA targeted in 2025 to discuss study outcomes.
CEO cites capital resources as single biggest limitation; evaluating all options to fund regulatory strategy.

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