AEON Biopharma announced receipt of official minutes from its FDA Type 2b meeting regarding the biosimilar development pathway for ABP-450, a proposed biosimilar to BOTOX. The FDA agreed in principle with AEON's two-stage comparative pharmacodynamic study design using CMAP measurement and indicated that previously completed Daewoong Pharmaceutical studies may be submitted as supportive evidence subject to scientific bridging. Consequently, the condition for accelerating the expiration of Two-Year Milestone Warrants was satisfied, causing them to expire on November 16, 2026. AEON plans to submit an IND for the CMAP study in Q4 2026 and initiate it in Q1 2027. The company operates as a biopharmaceutical firm developing biosimilars.
