AEON Biopharma, Inc., a pharmaceutical company specializing in preparations, announced today a significant strategic shift in the development of its lead drug candidate, ABP-450. The company is now focusing on a biosimilar regulatory pathway, following a recent meeting with the U.S. Food and Drug Administration (FDA).
The Irvine, California-based company, formerly known as Priveterra Acquisition Corp., plans to conduct a pivotal clinical study on ABP-450 for the treatment of cervical dystonia. This move comes as part of AEON's reprioritization to pursue a 351(k) biosimilar pathway using AbbVie Inc (NYSE:ABBV).’s BOTOX as the reference product.
AEON's strategy is to demonstrate that ABP-450 is highly similar to the reference product in terms of safety, purity, and potency. If the Phase 3 comparative study is successful, it could potentially satisfy the clinical data requirements for ABP-450 to be considered interchangeable with BOTOX for all of its current and future approved therapeutic indications.
The company also disclosed plans to engage in further discussions with the FDA during a Biosimilar Initial Advisory Meeting, which is scheduled for the third quarter of 2024. This meeting is expected to provide additional guidance on the development and regulatory requirements for the proposed biosimilar pathway.
AEON Biopharma, listed on the NYSE American under the ticker AEON, is an emerging growth company that has elected not to use the extended transition period for complying with new or revised financial accounting standards provided under Section 13(a) of the Exchange Act.
This news was confirmed through a report filed with the Securities and Exchange Commission on July 9, 2024, by Marc Forth, the Chief Executive Officer of AEON Biopharma, Inc.
The article is based on an 8K filing.
In other recent news, AEON Biopharma Inc., a clinical-stage biopharmaceutical company, has undergone significant restructuring, including cost reductions and layoffs, to extend its financial runway into Q4 2024. The company has also seen changes in key leadership roles, with Marc Forth, the CEO, taking over as principal financial officer.
The strategic reorganization comes after the discontinuation of the Phase 2 study of ABP-450.
In response to these developments, H.C. Wainwright has adjusted its outlook on AEON Biopharma, reducing the price target from $18.00 to $6.00 while maintaining a Buy rating.
InvestingPro Insights
In light of AEON Biopharma's strategic pivot to pursue a biosimilar pathway for its ABP-450 drug candidate, current and prospective investors may find recent metrics and analysis from InvestingPro particularly relevant. AEON's market capitalization stands at a modest $39.9 million, reflecting the company's emerging growth status within the pharmaceutical sector. The company's financial health is a point of concern, with a negative P/E ratio over the last twelve months as of Q1 2024, signaling that AEON is not currently generating profits. This is further supported by an InvestingPro Tip indicating that analysts do not expect the company to be profitable this year.
Investors should note that AEON's stock has experienced a significant decline over the past year, with a one-year price total return of -86.49% as of the date provided. Additionally, the company's stock is currently trading at only 5.94% of its 52-week high. This volatility is something that potential investors should factor into their decision-making process, especially considering another InvestingPro Tip that highlights the stock's high price volatility.
For those looking to delve deeper into AEON's financial outlook and stock performance, there are additional InvestingPro Tips available that could provide further insights. In particular, the tips reveal concerns such as weak gross profit margins and short-term obligations exceeding liquid assets. To access these insights and more, investors can visit https://www.investing.com/pro/AEON. Moreover, for a limited time, use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, which includes a total of 12 additional InvestingPro Tips that could help in making more informed investment decisions.
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