AEON Receives FDA Feedback, Clarifying Development Path for BOTOX Biosimilar ABP-450

AEON Biopharma announced it received official minutes from a Type 2b meeting with the U.S. Food and Drug Administration (FDA) regarding the development pathway for its drug candidate ABP-450, a proposed biosimilar to BOTOX®. The feedback provides a clearer regulatory path and supports a potentially more efficient clinical development program, which may not require a standalone comparative efficacy study.

Key Details

• Regulatory Path: The FDA agreed in principle with AEON's proposed pharmacodynamic study and indicated that previously conducted clinical studies may be submitted as supportive evidence, potentially streamlining the approval process.
• Upcoming Milestones: The company plans to submit an Investigational New Drug (IND) application for its CMAP study in Q4 2026 and initiate the study in Q1 2027. AEON intends to present its complete evidence package to the FDA in 2027.
• Warrant Expiration: As a result of this development, the company's Two-Year Milestone Warrants will have their expiration date accelerated to November 16, 2026, unless exercised prior.