Tuesday, AEON Biopharma, Inc (NYSE:AEON) maintained its Buy rating and $5.00 price target from H.C. Wainwright, following the company's update on its recent interaction with the FDA. AEON announced that it received the minutes from its biosimilar initial advisory (BIA) meeting with the FDA regarding ABP-450 injection, a proposed biosimilar of Botox.
The company reported that it is in agreement with the FDA on the additional analytical and characterization studies needed to fulfill the requirements of a comparative analytical assessment (CAA). This step is part of the standard 351k biosimilar pathway, which is essential for the approval process of biosimilar drugs.
AEON expressed confidence in its ability to complete the necessary analytical work satisfactorily. The firm's analysts believe that the successful completion of the CAA could signify a lower risk for subsequent clinical studies, particularly if the indication is for chronic diseases (CD).
AEON's management's expectations align with the FDA's guidance, which is a positive sign for the company's progress toward bringing ABP-450 to market as a biosimilar product. The company's proactive approach and alignment with regulatory requirements have been positively noted by the analyst.
The reiterated Buy rating and price target reflect the analyst's confidence in AEON's ability to navigate the biosimilar approval pathway effectively. The company's ability to meet the FDA's analytical and characterization study requirements for ABP-450 is seen as a crucial step toward potential market entry.
In other recent news, AEON Biopharma has been making significant progress in its development of ABP-450, a potential biosimilar to Botox. The company has aligned with the FDA on the regulatory pathway for the product, with plans to initiate comparative analytical studies in Q4 2024. The results of these studies will be reviewed in a Biosimilar Biological Product Development Type 2 meeting with the FDA in 2025.
The company has also revealed its plans to conduct a Phase 3 study in cervical dystonia, aiming to demonstrate that ABP-450 is not inferior to Botox. This strategy, supported by H.C. Wainwright, could potentially open up the entire Botox market for AEON Biopharma with just one successful study.
Additionally, AEON Biopharma has undergone significant 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, maintaining a Buy rating for the company's stock, albeit with a reduced price target from $18.00 to $6.00.
InvestingPro Insights
AEON Biopharma's recent positive interaction with the FDA aligns with some encouraging financial metrics and market trends. According to InvestingPro data, AEON has shown a significant return over the last week, with a 43.66% price total return. This short-term surge could be attributed to the market's positive reaction to the company's progress with the FDA regarding ABP-450.
Despite the recent uptick, it's important to note that AEON's stock has faced challenges over the longer term. InvestingPro Tips highlight that the stock has taken a big hit over the last six months, which is reflected in the -85.87% price total return over that period. This volatility underscores the importance of the company's current regulatory progress in potentially reversing its fortunes.
On a positive note, analysts predict that AEON will be profitable this year, which could be a turning point for the company if realized. This projection, combined with the expected growth in net income, suggests that AEON's strategic focus on developing ABP-450 as a biosimilar could pay off in the near future.
For investors seeking a more comprehensive analysis, InvestingPro offers 12 additional tips for AEON, providing a deeper understanding of the company's financial health and market position.
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