AEON Biopharma plans IND filing for CMAP pharmacodynamic trial of ABP-450 biosimilar in Q4 2026

Bitget2026/09/30 12:02

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AEON Biopharma received FDA Type 2b meeting minutes that support a potentially streamlined biosimilar path for ABP-450 versus BOTOX.
Previously completed head-to-head studies versus BOTOX were already conducted; FDA signaled they may support the filing if scientifically bridged.
AEON plans to submit an IND in Q4 2026 for a CMAP pharmacodynamic study, with trial initiation targeted for Q1 2027.
Strategy aims to reduce or avoid a standalone comparative efficacy study, pending whether integrated evidence resolves remaining biosimilarity questions.
AEON expects to return to FDA in 2027 with an integrated evidence package to support a potential 351(k) BLA submission.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. AEON Biopharma Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001837607-26-000064), on September 30, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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AEON Biopharma plans IND filing for CMAP pharmacodynamic trial of ABP-450 biosimilar in Q4 2026

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