Full Press Release Details
- First closing of PIPE resulted in ~$1.79M in proceeds -
- FDA BPD Type 2a meeting now scheduled for January 21, 2026 -
IRVINE, Calif., Nov. 20, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company seeking accelerated and full-label U.S. market entry by developing ABP-450 (prabotulinumtoxinA) as a BOTOX (onabotulinumtoxinA) biosimilar, today announced the first closing of its previously announced private placement (“PIPE”). Additionally, the Company announced that the U.S. Food and Drug Administration (the “FDA”) has proposed a new date of January 21, 2026 for AEON’s Biosimilar Biological product Development (BPD) Type 2a meeting. The meeting had previously been scheduled for November 19, 2025.
The first closing of the PIPE occurred on November 18, 2025 and resulted in $1.79 million in proceeds to AEON. The second closing of the PIPE will be subject to stockholder approval and the satisfaction of the other closing conditions required under the securities purchase agreement entered for the transaction. The first closing proceeds, along with the anticipated proceeds from the second closing, will enable uninterrupted execution of AEON’s analytical program and are expected to accelerate ABP-450’s biosimilar development by up to six months.
Separately, on November 18, 2025, the FDA informed AEON that the BPD Type 2a meeting would be rescheduled and proposed January 21, 2026 as the new meeting date. The Type 2a meeting will review AEON’s analytical development plan and initial data supporting biosimilarity. The FDA did not cite any scientific or program-related issues in connection with the scheduling change and promptly provided the Company with the new proposed date, underscoring continued engagement with AEON’s biosimilar program.
“Securing the funds from the first closing of the PIPE allows us to maintain full program momentum,” said Rob Bancroft, President & Chief Executive Officer of AEON. “We look forward to our Type 2a meeting with the FDA where we expect to align on the remaining analytical work to advance toward expedited U.S. therapeutic market entry.”
About the U.S. Biosimilar Pathway
The U.S. Food and Drug Administration (“FDA”) regulates biosimilars under the Public Health Service Act’s 351(k) pathway, which require developers to 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 is the scientific foundation of this process, representing the most critical and data-intensive phase of development. Once analytical comparability across key quality attributes is established, subsequent FDA interactions focus on confirming whether any residual uncertainty requires limited clinical evaluation.
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. The U.S. therapeutic neurotoxin market exceeds $3.0 billion annually, representing a major opportunity for biosimilar entry. 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®. 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. For example, statements regarding expected meetings with the FDA or the expected benefits of AEON’s previously announced PIPE transaction are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements.
These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to the ability of the Company to obtain stockholder approval for the PIPE transaction and the ability of the Company to satisfy other closing conditions; and other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the Securities and Exchange Commission (the "SEC"), which are available on the SEC’s website at www.sec.gov.
Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements.
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Source: AEON Biopharma