Aeon Biopharma Reveals FDA Meeting Scheduled for ABP-450 Under BPD Type 2a Designation
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Oct 01 2025
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FDA Meeting Scheduled: AEON Biopharma's ABP-450 has a Type 2a meeting with the FDA set for November 19, 2025, to discuss its biosimilar development plan.
Focus on Analytical Development: The meeting will address AEON's analytical development plan under the 351(k) biosimilar pathway, including quality attributes and initial similarity data.
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Analyst Views on AEON
About AEON
AEON Biopharma, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on developing its botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection or ABP-450, for debilitating medical conditions, with an initial focus on the neuroscience market. ABP-450 is a 2-chain polypeptide, a heavy chain joined by a bond to a light chain. ABP-450 interferes with nerve impulses by inhibiting the release of acetylcholine into the neuromuscular junction, causing a flaccid paralysis of muscles. The active biologic ingredient in ABP-450 is Clostridium botulinum toxin, type A with a complete molecular complex weight of 900 kDa. Its initial development programs for ABP-450 are directed at migraine, cervical dystonia, gastroparesis and post-traumatic stress disorder (PTSD). The Company has completed enrollment and dosing of patients for a Phase II double blind study of ABP-450 for the treatment of both chronic and episodic migraine.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
AEON Biopharma Holds FDA BPD Meeting, Secures $22 Million Financing
- FDA Meeting Progress: AEON Biopharma completed its BPD Type 2a meeting with the FDA, expecting to receive official meeting minutes within 30 days, which will provide crucial guidance for the further development of ABP-450, enhancing the company's competitive edge in the biosimilar market.
- Financing Transaction Details: AEON's PIPE financing plan is expected to yield approximately $22 million in potential proceeds, including the sale of 6.58 million shares of Class A common stock at $0.9116 per share, with initial financing already generating $6 million in gross proceeds, thereby improving the company's balance sheet.
- Convertible Note Exchange: AEON and Daewoong Pharmaceutical agreed to exchange $15 million of convertible notes for approximately 23.10 million AEON shares and a new $1.5 million convertible note, which is expected to significantly reduce the company's debt burden and simplify its capital structure.
- Stock Price Fluctuation: AEON's stock traded between $0.3750 and $11.0160 over the past year, closing at $1.36 with a 13.33% increase, although it fell 4.41% in pre-market trading, reflecting market attention on the company's financing and growth prospects.
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AEON Biopharma Holds FDA BPD Meeting, Shareholders Approve PIPE Financing
- FDA Meeting Progress: AEON successfully held its BPD Type 2a meeting today and expects to receive the official minutes within 30 days, marking an important procedural milestone that will provide crucial guidance for the subsequent development of ABP-450, facilitating the company's entry into the U.S. market.
- Shareholder Support for Financing: AEON's shareholders voted today to approve transactions announced in November, including PIPE financing and the exchange of Daewoong's convertible notes, which is expected to significantly reduce the company's debt burden and simplify its capital structure, thereby enhancing financial stability.
- Significant Market Opportunity: The U.S. therapeutic neurotoxin market exceeds $3 billion annually, and AEON's ABP-450, as a biosimilar to BOTOX®, has the potential to enter this rapidly growing market, strategically enhancing the company's competitive position.
- Production Compliance Assurance: ABP-450 is manufactured by Daewoong Pharmaceutical in a facility compliant with cGMP standards, approved by the FDA, Health Canada, and the European Medicines Agency, ensuring product quality meets international standards and enhancing market trust.
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