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Item 8.01. Other Events.
On July 9, 2024, AEON Biopharma, Inc. (the “Company”) announced a strategic reprioritization to pursue a 351(k) biosimilar regulatory pathway for its lead candidate, ABP-450, using AbbVie Inc.’s product BOTOX as the reference product, and plans to advance a single pivotal clinical development study in cervical dystonia for ABP-450 using this pathway, following a meeting with the United States Food and Drug Administration (“FDA”). A successful Phase 3 comparative study in cervical dystonia would potentially provide the necessary clinical data to support a determination that ABP-450 is highly similar to the reference product for up to all of its eight currently approved and future therapeutic indications.
The Company also announced plans to discuss the proposed biosimilar pathway with the FDA during a Biosimilar Initial Advisory Meeting currently scheduled for the third quarter of 2024.