AEON Biopharma Reports BPD Type 2a Meeting with FDA and Shareholder Approval of the November Transactions

Core Insights - AEON Biopharma has successfully completed its BPD Type 2a meeting with the FDA, marking a significant procedural milestone in the development of its biosimilar product ABP-450, which aims to compete with BOTOX [1][2][6] - Shareholders have approved key transactions that will enhance the company's financial position, including PIPE financing and the exchange of convertible notes with Daewoong Pharmaceutical, which will simplify AEON's capital structure and reduce outstanding debt [1][6] Company Overview - AEON Biopharma is focused on gaining accelerated and full-label access to the U.S. therapeutic neurotoxin market, which exceeds $3.0 billion annually, through the development of ABP-450 as a biosimilar to BOTOX [4] - ABP-450 is manufactured by Daewoong Pharmaceutical under cGMP standards and is already approved as a biosimilar in India, Mexico, and the Philippines, with exclusive rights for therapeutic indications in the U.S., Canada, EU, UK, and other territories [4] Regulatory Context - The FDA regulates biosimilars under the Public Health Service Act's 351(k) pathway, requiring developers to demonstrate that their product is highly similar to an approved reference biologic without clinically meaningful differences in safety, purity, or potency [3]