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AEON 資訊
AEON 事件
Aeon Biopharma Appoints Paul Lee as Acting Chief Regulatory Officer
Aeon Biopharma announced the designation of Paul Lee as the company's acting chief regulatory officer, through Clintrex. Lee and Clintrex currently advise Aeon on the regulatory and clinical development strategy for ABP-450, providing strategic guidance as the company advances its biosimilar development program. In his acting chief regulatory officer role, Lee will lead Aeon's regulatory strategy, help guide the company's interactions with the FDA and work closely with Aeon's analytical, CMC and clinical teams as it advances ABP-450 under the 351 biosimilar pathway.
Aeon Biopharma Prices Public Offering to Raise Up to $43.3M
Aeon Biopharma announced the pricing of its underwritten public offering to raise up to approximately $43.3M in gross proceeds based on the approximately $13.75M in expected gross proceeds from the offering and up to an additional $29.6M in potential gross proceeds upon the cash exercise in full of the milestone warrants issued in the offering. The offering consists of 42.69M shares of common stock of the company, with each share of common of the company, with each share of common stock or pre-funded warrant accompanied by one two-year milestone warrant to purchase one share of common stock and one five-year milestone warrant to purchase one share of common stock. The combined public offering price is 32.21c per share of common stock and accompanying two-year milestone warrant and five-year milestone warrant. The proceeds from this offering are expected to be used for working capital and general corporate purposes, including conducting comparative analytical testing on ABP-450 to support biosimilarity to Botox. The offering is expected to close on or about July 15, subject to satisfaction or waiver of customary closing conditions. Lake Street Capital Markets is acting as the sole bookrunner for this offering. Laidlaw & Company is acting as lead manager for the offering.
AEON Biopharma Receives NYSE Warning
AEON Biopharma announced that on March 31, 2026, it received a notice from NYSE American indicating that, following its year-end financial results, the Company is not in compliance with an additional continued listing standard set forth in the NYSE American Company Guide.
Aeon Biopharma Receives FDA Feedback to Advance ABP-450 Development
Aeon Biopharma announced feedback from the FDA following a biosimilar biological product development Type 2a meeting. During the meeting, held in January, the FDA reviewed the company's proposed analytical similarity strategy under the 351(k) biosimilar pathway and provided feedback supporting the company's planned analytical development approach. The agency acknowledged the scientific challenges associated with characterizing a 900 kDa botulinum neurotoxin complex, provided constructive feedback on the company's proposed development approach and analytical assessment plan, and noted that Aeon's analytical methodologies appeared reasonable to support advancement of the program toward a comprehensive analytical similarity package. The company believes this feedback provides a clear framework for the remaining analytical components of its biosimilar development program and plans to complete the majority of its analytical comparability program in 2026. Aeon is currently planning to request a BPD Type 2b meeting in 2026 to discuss the next phase of the development program to support approval of ABP-450 as a biosimilar to Botox across all approved therapeutic indications.
Aeon Biopharma Appoints John Bencich as CFO
Aeon Biopharma (AEON) announced the appointment of John Bencich as CFO. Most recently, he served as CEO of Achieve Life Sciences (ACHV).
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