AEON Biopharma FDA Type 2b minutes support ABP-450 biosimilar path; milestone warrants to expire Nov 16, 2026

AEON Biopharma, Inc.

FDA agreed in principle with two-stage CMAP pharmacodynamic study design in extensor digitorum brevis muscle; AEON plans an IND in Q4 2026 and study start in Q1 2027.
FDA said Daewoong's prior comparative studies in blepharospasm, upper limb spasticity, glabellar lines and lateral canthal lines may be submitted as supportive evidence, subject to bridging.
AEON does not intend to start a standalone comparative efficacy study now; it will weigh its analytical, PD and human evidence and return to FDA in 2027 with an integrated package.
Two-Year Milestone Warrants expire Nov 16, 2026 after AEON determined the Type 2b minutes do not preclude advancement toward a 351(k) BLA, triggering the acceleration clause.
CEO Rob Bancroft cited a potentially more efficient development program; FDA invited analyses supporting the earlier Phase 2 chronic migraine study for the BLA.

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