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AEON Biopharma ( NYSE: AEON ) on Tuesday said that it had announced plans to advance a single clinical development study in cervical dystonia for ABP-450 injection, utilizing the 351(k) regulatory pathway for biosimilars with BOTOX ((onabotulinumtoxinA)) as the reference product. The company added that under the 351(k) biosimilar regulatory pathway, its plans rely upon extensive analytical and preclinical testing, much of which has already been completed. Following the FDA meeting scheduled to take place in the third quarter of 2024, the company expects to move ahead with a planned Phase 3 CD study in about 400 patients to evaluate a direct comparison of ABP-450 to BOTOX.

The purpose of the study is to demonstrate non-inferiority to BOTOX and would serve as the basis for a BLA filing. Press release. More on AEON Biopharma, Inc.



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