AEON Biopharma, Inc.
- Market Cap (Float-Adj) (Float-adjusted market cap computed by the low-float screener — matches the screener row. May differ from the standard cap (price × all shares outstanding) reported elsewhere.)
- $15.5M
- Price
- $0.3113
- % Change (Daily % change from the live per-ticker quote feed.)
- +7.44%
- Volume
- 2.9M
About
AEON Biopharma, Inc. is a biopharmaceutical company primarily engaged in developing therapies based on botulinum toxins, aimed at treating various debilitating medical conditions. Among its key investigational products is ABP-450, a 900 kDa botulinum toxin complex, which is being advanced for therapeutic use in conditions such as migraine, cervical dystonia, and gastroparesis. The entity, originally known as ALPHAEON Corporation, adopted the name AEON Biopharma, Inc. in December 2019. Established in 2012, the company maintains its principal operations from Newport Beach, California.
Quick stats
Shares outstanding49.9M
Computed float34.2M
Float / shares68.6%
Key info
SectorHealthcare
IndustryBiotechnology
CIK (Central Index Key — the unique ID the SEC assigns to every filer. Use it to look up the company's filings on EDGAR.)0001837607
Websitehttp://www.aeonbiopharma.com
AI Summary
AI-generated1/15
standardbullishregulatory
AEON Biopharma FDA Type 2b Meeting Feedback Clarifies Biosimilar Development Plan for ABP-450
AEON Biopharma received official FDA minutes from its Type 2b biosimilar meeting on ABP-450, which clarify and potentially streamline the path to a 351(k) BLA submission for full-label therapeutic use as a BOTOX biosimilar.
The FDA agreed in principle with a two-stage CMAP pharmacodynamic study design and said previously completed head-to-head studies versus BOTOX can be submitted as supportive evidence, subject to scientific bridging. AEON does not plan a standalone comparative efficacy study at this time, citing FDA's October 2025 draft guidance.
Key milestones include IND filing for the CMAP PD study in Q4 2026, study initiation in Q1 2027, and returning to the FDA in 2027 with an integrated evidence package.
The U.S. therapeutic neurotoxin market exceeds $3.0 billion annually, making a streamlined pathway a significant capital-efficiency win for the clinical-stage company.
Red flags
- FDA may still require additional analytical, pharmacodynamic, or clinical studies
- scientific bridging of prior studies is a condition, not a guarantee, of their evidentiary value
- company discloses need for sufficient capital to fund planned development activities
- chronic migraine Phase 2 outcome requires additional analyses to support rationale