AEON Biopharma, Inc.
AEON Biopharma, Inc. is a clinical-stage biopharmaceutical company headquartered in Irvine, California, focused on the development of botulinum toxins for therapeutic applications. The company's mission is to expand access to high-quality therapeutic neurotoxin treatments for patients suffering from debilitating medical conditions, particularly those involving neuromuscular disorders.
The company's primary product candidate is ABP-450 (prabotulinumtoxinA) injection, which is being developed as a biosimilar to BOTOX® (onabotulinumtoxinA) for various therapeutic indications. AEON Biopharma is initially targeting the neurology and gastroenterology markets, with ABP-450 having completed a Phase 2 study for cervical dystonia and an ongoing Phase 2 study for chronic and episodic migraine. The company is also exploring its use for gastroparesis and post-traumatic stress disorder. ABP-450 is manufactured by Daewoong Pharmaceutical and is the same botulinum toxin complex currently marketed for cosmetic indications by Evolus, Inc. under the name Jeuveau®. AEON holds exclusive development and distribution rights for therapeutic indications of ABP-450 in key international territories, including the United States, Canada, the European Union, and the United Kingdom.
Robert E. Bancroft was appointed President and Chief Executive Officer in April 2025, and John Bencich became Chief Financial Officer in March 2026. In January 2026, AEON Biopharma received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its analytical similarity strategy for ABP-450, with plans to complete the analytical comparability program and request further meetings in 2026. The company also announced an exchange agreement with Daewoong in December 2025, aimed at significantly reducing its outstanding debt. While the company received a notice from NYSE American in March 2026 concerning noncompliance with continued listing standards due to a stockholders' deficit, it remains listed and is operating under an existing compliance plan. AEON Biopharma is strategically positioned to enter the multi-billion dollar therapeutic botulinum toxin market by leveraging the FDA's 351(k) biosimilar pathway to achieve full-label access for ABP-450.
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