{"id":829145,"date":"2025-03-24T16:21:41","date_gmt":"2025-03-24T20:21:41","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/aeon-biopharma-reports-fourth-quarter-and-full-year-2024-financial-results-and-provides-corporate-update\/"},"modified":"2025-03-24T16:21:41","modified_gmt":"2025-03-24T20:21:41","slug":"aeon-biopharma-reports-fourth-quarter-and-full-year-2024-financial-results-and-provides-corporate-update","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/aeon-biopharma-reports-fourth-quarter-and-full-year-2024-financial-results-and-provides-corporate-update\/","title":{"rendered":"AEON Biopharma Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update"},"content":{"rendered":"
\n

\n \u2013 Initiated analytical studies in Q4 2024<\/em>
\n to prepare for a potential Biosimilar Biological Product Development (\u201cBPD\u201d) Type 2a meeting with the FDA in the second half of 2025<\/em>
\n \u2013<\/em>\n <\/p>\n

\n \u2013 Pursuing a 351(k) regulatory pathway for ABP-450, which offers potential access to the U.S. market under a single approval for all of BOTOX\u2019s currently approved and future therapeutic indications<\/em>
\n \u2013 <\/em>\n <\/p>\n

IRVINE, Calif., March 24, 2025 (GLOBE NEWSWIRE) — AEON Biopharma, Inc. (\u201cAEON\u201d or the \u201cCompany\u201d) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update.<\/p>\n

\u201cWe are excited to move ahead with our biosimilar development program for ABP-450 under the 351(k) regulatory pathway utilizing BOTOX as the reference product. As part of this program, we initiated the primary analytical studies in the fourth quarter of 2024. The data from these studies will be used to complete the primary comparative analytical assessment, which the FDA will use to evaluate and determine the next steps for the program,\u201d commented Marc Forth, AEON\u2019s President and Chief Executive Officer.<\/p>\n

\u201cWe are excited by the progress our team is making along this regulatory pathway, which we believe could allow us to bring ABP-450 to the U.S. market for all of BOTOX\u2019s currently approved and future therapeutic indications under a single FDA approval. The financing we closed in January provided the critical funding that will allow us to work through our Biosimilar BPD Type 2a meeting with FDA. We look forward to announcing the results of that meeting and next steps in our development program, which we believe will offer a clear pathway for investors to see the opportunity AEON has to build significant shareholder value,\u201d concluded Mr. Forth.<\/p>\n

\n Recent Clinical and Corporate Highlights<\/strong>\n <\/p>\n