--- title: "AEON says FDA feedback may support a streamlined ABP-450 development path" url: "https://aibio.space/news/aeon-says-fda-feedback-may-support-streamlined-abp-450-development/" publisher: "aibio.space (Biotech Investor Relations News)" date: "2026-09-30" section: "Company Updates" tickers: "AMEX:AEON" source: "https://www.sec.gov/Archives/edgar/data/1837607/000183760726000064/aeon-ex99d1.htm" summary: "AEON Biopharma received official minutes from a Type 2b meeting with the FDA on its BOTOX biosimilar. It plans to file an IND for a comparative pharmacodyn" --- By the aibio.space news desk. Sources - [AEON Biopharma, Inc. 8-K (2026-09-30)](https://www.sec.gov/Archives/edgar/data/1837607/000183760726000064/aeon-ex99d1.htm) - [AEON Biopharma, Inc. 10-K (2026-03-30): business](https://www.sec.gov/Archives/edgar/data/1837607/000183760726000019/aeon-20251231x10k.htm) - [AEON Biopharma, Inc. financial data (SEC XBRL)](https://www.sec.gov/Archives/edgar/data/1837607/000183760726000019/) [AEON](https://aibio.space/companies/aeon-biopharma/) 2026-09-30 # AEON says FDA feedback may support a streamlined ABP-450 development path Tickers [AEON](https://aibio.space/companies/aeon-biopharma/) AEON Biopharma received official minutes from a Type 2b meeting with the FDA on its BOTOX biosimilar. It plans to file an IND for a comparative pharmacodynamic study in the fourth quarter of 2026. ## Key facts - **Company**: AEON Biopharma, Inc. (AMEX: AEON) - **News type**: Company Updates - **Primary source**: [AEON Biopharma, Inc. 8-K (2026-09-30)](https://www.sec.gov/Archives/edgar/data/1837607/000183760726000064/aeon-ex99d1.htm) *Reading a sequencing gel, 1980. Photo: Linda Bartlett, public domain, via Wikimedia Commons. The picture shows the field, not the companies named.* AEON Biopharma, Inc. (NYSE American: [AEON](https://aibio.space/companies/aeon-biopharma/)) said on September 30, 2026 that it had received the official minutes from its Biosimilar Biological Product Development (BPD) Type 2b meeting with the U.S. Food and Drug Administration. The meeting covered the development pathway for ABP-450, a botulinum toxin complex the company is advancing as a biosimilar to BOTOX (onabotulinumtoxinA) for therapeutic use. Rob Bancroft, President and Chief Executive Officer, said: "The Type 2b meeting feedback provides greater clarity on the development pathway for ABP-450 and, consistent with FDA's recent biosimilar guidance, supports a potentially more efficient clinical development program." ## The FDA feedback On a comparative pharmacodynamic (PD) study that measures compound muscle action potential (CMAP) in the extensor digitorum brevis muscle, AEON proposed a two-stage design: an initial dose-finding stage followed by a comparative PD evaluation. The FDA agreed in principle with the dose-finding stage, which will be conducted in healthy volunteers, and recommended steps to strengthen the study's ability to demonstrate assay sensitivity. The FDA also said comparative clinical studies previously conducted by Daewoong Pharmaceutical, across blepharospasm, upper limb spasticity, glabellar lines and lateral canthal lines, can be submitted as supportive evidence. That is subject to scientific bridging to U.S.-licensed BOTOX and between the ABP-450 drug product used in each study and ABP-450 as currently manufactured. AEON said each of those studies met its pre-specified non-inferiority endpoint. On a comparative clinical efficacy study, the FDA said any additional clinical evidence should be sensitive enough to detect a meaningful difference between the products, if one exists. AEON does not intend to start a comparative efficacy study at this time. It will first evaluate its analytical, pharmacodynamic and comparative human evidence. For chronic migraine, the FDA invited the company to analyze its previously conducted Phase 2 study for the prevention of migraine headache, which AEON intends to include in its 351(k) Biologics License Application (BLA) submission. ## Next steps and background AEON plans to submit an IND for the CMAP PD study in the fourth quarter of 2026, with study initiation in the first quarter of 2027. It also plans to complete scientific bridging of ABP-450 to BOTOX and to return to the FDA in 2027 with an integrated evidence package. The release says the company hopes converging evidence will show that a standalone comparative efficacy study may not further inform a determination of biosimilarity. According to the [annual report](https://www.sec.gov/Archives/edgar/data/1837607/000183760726000019/aeon-20251231x10k.htm), ABP-450 is the same botulinum toxin complex approved as a biosimilar in Mexico, India and the Philippines. In the U.S., it is approved for temporary improvement in the appearance of moderate to severe glabellar lines in certain adult patients and is marketed by Evolus, Inc. as Jeuveau. Financially, AEON reported research and development expense of $4.1 million for 2025, compared with $14.2 million for 2024, and a net loss of $39.2 million for 2025. Cash flow from operations was negative $17.3 million in 2025 and negative $20.3 million in 2024. Year-end cash and cash equivalents were $3.0 million at December 31, 2025, according to a 10-Q filed August 12, 2026, and the company reported $3.4 million at June 30, 2026. ## What the feedback does not settle Meeting minutes are guidance, not an agreement to skip anything. The FDA agreed only "in principle" with the dose-finding stage, asked for changes to strengthen the study, and said any further clinical evidence must be sensitive enough to find a difference if one exists. It has not said a comparative efficacy study is unnecessary; the company only hopes the evidence will converge. The earlier Daewoong studies count as support only after scientific bridging, and the release does not describe the result of the company's Phase 2 migraine study, which the FDA asked it to explain. No IND has been filed and no BLA submitted. Cash was $3.4 million at June 30, 2026, against negative $17.3 million of operating cash flow in 2025. The full [release](https://www.sec.gov/Archives/edgar/data/1837607/000183760726000064/aeon-ex99d1.htm) is available on the SEC website. [Report an error](https://aibio.space/reputation/#correction) ## Companies in this story AEON AEON Biopharma, Inc. 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Cite as: aibio.space, "AEON says FDA feedback may support a streamlined ABP-450 development path", 2026-09-30, https://aibio.space/news/aeon-says-fda-feedback-may-support-streamlined-abp-450-development/