AEON Biopharma Announces FDA Meeting Minutes; ABP-450 Pathway Update

What Happened

• AEON Biopharma announced on September 30, 2026 that it received the official minutes from its Biosimilar BPD Type 2b meeting with the U.S. Food and Drug Administration (FDA) regarding ABP-450, a proposed biosimilar to BOTOX® (onabotulinumtoxinA).
• The FDA agreed in principle with AEON’s proposed two-stage comparative pharmacodynamic study using Compound Muscle Action Potential (CMAP) in the extensor digitorum brevis muscle (dose-finding stage then comparative evaluation). AEON expects to file an IND for the CMAP study in Q4 2026 and to initiate the study in Q1 2027.
• The FDA said prior comparative clinical studies conducted by Daewoong Pharmaceutical could be considered as supportive evidence if AEON performs appropriate scientific bridging to U.S.-licensed BOTOX® and to AEON’s current ABP-450 product. AEON plans to complete that bridging and return to the FDA in 2027 with an integrated evidence package.

Key Details

• Filing/announcement date: September 30, 2026.
• Planned IND submission for CMAP study: Q4 2026. Planned CMAP study start: Q1 2027.
• Warrant impact: AEON determined the meeting minutes do not preclude advancement toward a Section 351(k) biosimilar BLA; as a result, Two-Year Milestone Warrants will accelerate and expire on November 16, 2026 (45 days after the public announcement).
• FDA guidance: recommended study design changes to strengthen assay sensitivity and said more sensitive biological-activity measures may be acceptable instead of traditional clinical efficacy endpoints if needed.

Why It Matters

• For investors, the filing signals regulatory progress for ABP-450 under the FDA biosimilar pathway and a clear near-term development plan (IND filing and CMAP study timing).
• Acceleration of the milestone warrants to November 16, 2026 may affect warrant holders and potential dilution/timing of exercise activity for the company’s capital structure.
• The FDA’s openness to pharmacodynamic approaches and use of prior studies with scientific bridging could shorten or streamline development if AEON’s analytical and bridging work is successful, but AEON notes the FDA has not determined ABP-450 to be biosimilar and additional studies may still be required.