(NYSE MKT:AEON),
IRVINE, Calif., March 05, 2026 (GLOBE NEWSWIRE) — AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX(R) (onabotulinumtoxinA) to achieve accelerated and full-label U.S. market entry, today announced a poster presentation at the 2026 American Academy of Neurology (AAN) Annual Meeting, taking place April 18-22, 2026, in Chicago, IL.
The abstract builds upon analytical data previously reported by the Company demonstrating identical primary amino acid sequence between ABP-450 and the reference product, based on 93.5%-99.3% peptide sequence coverage across BoNT/A1 and associated accessory proteins, with no variant peptides observed across multiple lots. Primary structure confirmation represents a foundational component of biosimilar development and supports AEON's analytical similarity package for ABP-450.
The AAN Annual Meeting represents the largest annual gathering of neurologists in the United States, the specialty responsible for the largest volume of therapeutic botulinum toxin injections.
AAN 2026 Presentation Details:
Title: Establishing Primary Structure Comparability Between ABP-450 (prabotulinumtoxinA) and OnabotulinumtoxinA (Botox(R)) to Support Biosimilarity
Format: Poster Presentation (abstract # 4146, presentation #010 in Neighborhood 7)
Session: P11: General Neurology: Pharmaceuticals
Presenter: Chad K. Oh, M.D., Chief Medical Officer, AEON Biopharma
Date: Wednesday, April 22, 2026
Time: 11:45 am – 12:45 pm CT
About the U.S. Biosimilar Pathway
Under the FDA's 351(k) biosimilar pathway, developers must demonstrate that a proposed product is highly similar to an approved reference biologic, with no clinically meaningful differences in safety, purity, or potency. Analytical similarity represents the scientific foundation of this process, integrated with clinical and regulatory strategy to form a totality-of-evidence assessment. FDA engagement focuses on determining the scope of data necessary to address residual uncertainty, which may include analytical, nonclinical, or clinical components as appropriate.
About AEON Biopharma
AEON Biopharma is a biopharmaceutical company seeking accelerated and full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX(R). The U.S. therapeutic neurotoxin market exceeds $3.0 billion annually and represents a significant opportunity for high-quality biosimilar competition. The Company's lead asset is ABP-450 for debilitating medical conditions. ABP-450 is the same botulinum toxin complex currently approved and marketed for cosmetic indications by Evolus, Inc. under the name Jeuveau(R). ABP-450 is manufactured by Daewoong Pharmaceutical in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada, and European Medicines Agency. The product is approved as a biosimilar in India, Mexico, and the Philippines. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. To learn more about AEON, visit www.aeonbiopharma.com.
Forward-Looking Statements
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON's future financial or operating performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, regulatory developments, biosimilar program results, and other risks described in the Company's filings with the Securities and Exchange Commission.
Contacts
Investor Contact:
Laurence Watts
New Street Investor Relations
+1 619 916 7620
laurence@newstreetir.com
