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(RTTNews) - Wednesday, AEON Biopharma (AEON) said FDA feedback from a Type 2b meeting provided clarity on the development pathway for ABP-450 as a biosimilar to BOTOX.
ABP-450 is a botulinum toxin being developed for therapeutic indications. AEON plans to submit an IND for a comparative pharmacodynamic study using Compound Muscle Action Potential (CMAP) measurements in the fourth quarter of 2026.
The FDA indicated that previously completed comparative studies of ABP-450 versus BOTOX could be submitted as supportive evidence, subject to scientific bridging.
AEON does not plan to initiate a standalone comparative efficacy study at this time and will evaluate its analytical, pharmacodynamic and comparative human evidence to determine whether additional clinical studies are needed.
AEON shares closed on Tuesday at $0.25, down 0.99%. In the Premarket trading, shares are up 3.42% at $0.27.