AEON News & Events

Aeon confirmed that it held its scheduled BPD Type 2a meeting with FDA, in line with prior guidance. The company said it looks forward to commenting on the meeting's substance and outcome following receipt of the official meeting minutes from the FDA. Aeon also held a special meeting at which shareholders voted to approve the completion of the transactions announced in November, including the remaining issuances related to the company's private investment in public equity financing and the related exchange of the company's convertible notes held by Daewoong Pharmaceutical. "We are encouraged by the continued progress we are making early in 2026. The completion of our BPD Type 2a meeting with FDA represents an important procedural milestone, and we now look forward to receiving the official meeting minutes within approximately 30 days, which we expect will help inform next steps for the development of ABP-450, our biosimilar to BOTOX(R)," said Rob Bancroft, president and CEO of AEON. "Additionally, we are thankful to our shareholders for their support of the transactions we announced in November, which strengthen our balance sheet, simplify our capitalization structure and position the company to continue executing on our biosimilar program."

AEON Biopharma announced the first closing of its previously announced private placement. Additionally, the Company announced that the U.S. Food and Drug Administration has proposed a new date of January 21, 2026 for AEON's Biosimilar Biological product Development Type 2a meeting. The meeting had previously been scheduled for November 19. The first closing of the PIPE occurred on November 18 and resulted in $1.79M 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, 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.

"The foundation of AEON's progress lies in our science and is underscored by years of market validation", said Rob Bancroft, AEON's President and Chief Executive Officer. "Our recently released analytical results confirm both ABP-450's identical amino-acid sequencing of all visible portions and highly similar functional characteristics to BOTOX. These results are supported by a globally approved and fully scaled manufacturing platform with approvals in 69 countries. Together, these scientific and global data points validate our biosimilar strategy and instill confidence in AEON's path forward."

AEON Biopharma announced that the U.S. Food and Drug Administration has scheduled a Biosimilar Biological Product Development Type 2a meeting for ABP-450 on November 19, 2025, in line with prior guidance. The meeting will focus on AEON's analytical development plan under the 351(k) biosimilar pathway, including its framework for assessing key quality attributes and its initial similarity data. The objective of the discussion is to establish alignment with FDA on the scope and approach of the remainder of AEON's analytical analysis - a foundational step in advancing ABP-450's biosimilar development.