Business
AEON Biopharma Reports First Quarter 2025 Financial Results and Provides Corporate Update
– Continue to conduct analytical studies to prepare for a potential Biosimilar Biological Product Development (“BPD”) Type 2a meeting with the FDA in the second half of 2025 – – 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’s currently approved and future therapeutic indications – – Appointed Rob Bancroft as the Company’s President and Chief Executive Officer; Mr. Bancroft also joined AEON’s Board of Di
About this update from Aeon Biopharma, Inc.
[{"type":"image","alt":"AEON Biopharma","displaySize":"","headline":null,"caption":"AEON Biopharma","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":73,"url":"https://media.zenfs.com/en/globenewswire.com/4e5536b202731f8582e6bfa42a1b19a5"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/dGy5RFZ4cSVxL8LejqiO2Q--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTEwMjtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/4e5536b202731f8582e6bfa42a1b19a5","width":300,"height":73}},"lazy":false},{"type":"text","content":"– Continue to conduct analytical studies to prepare for a potential Biosimilar Biological Product Development (“BPD”) Type 2a meeting with the FDA in the second half of 2025 –","length":175,"tagName":"p"},{"type":"text","content":"– 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’s currently approved and future therapeutic indications –","length":199,"tagName":"p"},{"type":"text","content":"– Appointed Rob Bancroft as the Company’s President and Chief Executive Officer; Mr. Bancroft also joined AEON’s Board of Directors –","length":133,"tagName":"p"},{"type":"text","content":"IRVINE, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced its financial results for the first quarter ended March 31, 2025, and provided a business update.","length":363,"tagName":"p"},{"type":"text","content":"“I am excited to report that our team is quickly advancing the biosimilar development program for ABP-450 under the 351(k) regulatory pathway utilizing BOTOX as the reference product. By utilizing this pathway, we plan to bring ABP-450 to the U.S. market under a single FDA approval that could cover all of BOTOX’s currently approved and future therapeutic indications,” commented Rob Bancroft, AEON’s President and Chief Executive Officer. “We are making progress in conducting the primary analytical studies. Once the initial analytical studies are completed, we will be able to conduct the primary comparative analytical assessment, which the FDA will evaluate at our Biosimilar BPD Type 2a meeting and determine the next steps for the program.”","length"...