IRVINE, Calif. - AEON Biopharma, Inc. (NYSE: AEON), a clinical-stage biopharmaceutical company, has announced its alignment with the U.S. Food and Drug Administration (FDA) regarding the regulatory pathway for its product ABP-450 (prabotulinumtoxinA), intended as a biosimilar to BOTOX® (onabotulinumtoxinA). The announcement follows formal discussions between AEON and the FDA, which centered on the proposed 351(k) regulatory pathway and the necessary steps to move forward.
AEON plans to initiate comparative analytical studies in Q4 2024, a critical step in demonstrating biosimilarity to BOTOX®. Following these studies, a Biosimilar Biological Product Development (BPD) Type 2 meeting with the FDA is expected in 2025 to review the results and confirm the remaining requirements for the study package.
Marc Forth, President and CEO of AEON, expressed optimism about the company's progress and the potential to bring ABP-450 to market for both current and future therapeutic indications of BOTOX® through a single approval process.
The company has indicated that a Phase 3 program may be necessary to compare ABP-450 with its reference product, contingent on securing funding. The need for comparative clinical studies will be determined after the FDA reviews the results from the comparative analytical assessment (CAA).
AEON's proprietary botulinum toxin complex, ABP-450, is manufactured by Daewoong to meet current Good Manufacturing Practices (cGMP) and is already approved for cosmetic use under the name Jeuveau. The product has also been approved as a biosimilar in Mexico and India, and AEON holds exclusive development and distribution rights for therapeutic indications in various international territories.
The information in this article is based on a press release statement from AEON Biopharma. The company has cautioned that forward-looking statements within the release are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements should not be relied upon as guarantees of future performance.
In other recent news, AEON Biopharma has made significant strides in its pursuit of a biosimilar pathway for its lead drug candidate, ABP-450. The pharmaceutical firm plans to conduct a Phase 3 study in cervical dystonia, aiming to demonstrate that ABP-450 is not inferior to Botox. This strategy could potentially open up the entire Botox market for AEON Biopharma with just one successful study. An initial advisory meeting with the FDA has been scheduled for the third quarter of 2024 to discuss this development further.
In addition to these strategic shifts, AEON Biopharma has undergone considerable restructuring, including cost reductions and layoffs, to extend its financial runway into Q4 2024. Key leadership roles have also seen changes, with CEO Marc Forth assuming the role of principal financial officer.
Despite these changes and the discontinuation of the Phase 2 study of ABP-450, H.C. Wainwright continues to support AEON Biopharma. The investment firm has maintained a Buy rating for the company's stock, albeit with a reduced price target from $18.00 to $6.00. These are some of the recent developments surrounding AEON Biopharma.
InvestingPro Insights
AEON Biopharma's recent announcement regarding its regulatory pathway for ABP-450 comes at a time when the company's financial metrics paint a complex picture. According to InvestingPro data, AEON's market capitalization stands at $36.66 million, reflecting its current position in the biopharmaceutical sector.
The company's stock has shown significant volatility recently, with InvestingPro Tips highlighting a substantial return over the last week, as evidenced by a 34.62% price total return. This short-term gain contrasts sharply with the longer-term performance, as the stock has fallen significantly over the past year, with a one-year price total return of -83.43%.
Despite the recent positive news about its regulatory progress, AEON faces financial challenges. An InvestingPro Tip indicates that the company's short-term obligations exceed its liquid assets, which could potentially impact its ability to fund the planned comparative analytical studies and potential Phase 3 program mentioned in the article.
On a positive note, analysts predict that AEON will be profitable this year, aligning with the company's forward-looking statements about bringing ABP-450 to market. This optimism is further supported by another InvestingPro Tip suggesting that net income is expected to grow this year.
For investors seeking a more comprehensive analysis, InvestingPro offers additional insights, with 10 more tips available for AEON Biopharma. These additional tips could provide valuable context for understanding the company's financial health and market position as it progresses through the regulatory process for ABP-450.
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