AEON Biopharma, Inc. (AEON), a biopharmaceutical company, announced that it has received constructive feedback from the U.S. Food and Drug Administration following its Biosimilar Biological Product Development (BPD) Type 2a meeting for its lead investigational asset, ABP-450.
AEON is advancing ABP-450 (PrabotulinumtoxinA) as a biosimilar to BOTOX (OnabotulinumtoxinA) to achieve full-label U.S. market entry. Notably, ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus, Inc., under the name Jeuveau.
During the January 2026 meeting, the FDA reviewed AEON's proposed analytical similarity strategy under the 351(k) biosimilar pathway and provided feedback supporting the planned development approach.
AEON noted that the agency acknowledged a 900 kDa botulinum neurotoxin complex-associated challenge and provided constructive feedback on the proposed development approach and analytical assessment plan.
The agency also noted that AEON's analytical methodologies appeared reasonable for advancing the program toward a comprehensive analytical similarity package, according to the firm.
The firm believes this feedback provides a clear framework for the remaining analytical components of its biosimilar development program and plans to complete the majority of its analytical comparability program in 2026.
AEON is currently planning to request a BPD Type 2b meeting in 2026 to discuss the next phase of the development program to support approval of ABP-450 as a biosimilar to BOTOX across all approved therapeutic indications.
"We are highly encouraged by the FDA's constructive engagement regarding our analytical approach and the data generated to date," said Rob Bancroft, President and Chief Executive Officer of AEON.
ABP-450 is manufactured by Daewoong Pharmaceutical, and AEON has exclusive development and distribution rights for therapeutic indications in the United States, Canada, the European Union, the United Kingdom, and certain other international territories.
As of September 30, 2025, the company reported cash and cash equivalents of $5.9 million and, including the PIPE financing, earlier it expected to fund its operating plan through the second quarter of 2026.
AEON has traded between $0.37 and $1.4 in the last year. The stock closed Wednesday's trade at $1.02, down 3.77%.
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