AEON Biopharma Sets Q4 2026 IND Filing for ABP-450 Botox Biosimilar After FDA Type 2b Meeting

AEON Biopharma (AEON) said FDA feedback from a Type 2b meeting clarified the development pathway for ABP-450, its botulinum toxin candidate, as a biosimilar to BOTOX for therapeutic indications. The company plans to submit an investigational new drug application in the fourth quarter of 2026 for a comparative pharmacodynamic study using Compound Muscle Action Potential (CMAP) measurements. The FDA indicated that previously completed comparative studies of ABP-450 versus BOTOX could be submitted as supportive evidence, subject to scientific bridging. AEON said it does not plan to launch a standalone comparative efficacy study at this time and will assess its analytical, pharmacodynamic and comparative human data to determine whether additional clinical trials are needed. AEON shares closed Tuesday at $0.25, down 0.99%. In premarket trading, the stock rose 3.42% to $0.27.