AEON Biopharma Announces FDA Feedback Following BPD Type 2a Meeting for the ABP-450 Biosimilar Program
AEON Biopharma, Inc. Class A (AEON)
Company Research
Source: GlobeNewswire
FDA provided constructive feedback on Company’s analytical similarity strategy under the 351(k) biosimilar pathway Company continues to execute its analytical program and plans to request a BPD Type 2b meeting with the FDA in 2026 to discuss next steps in the development of ABP-450 as a biosimilar to BOTOX® IRVINE, Calif., March 25, 2026 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX® (onabotulinumtoxinA) to achieve full-label U.S. market entry, today announced feedback from the U.S. Food and Drug Administration (“FDA” or the “Agency”) following a successful Biosimilar Biological Product Development (BPD) Type 2a meeting. During the meeting, held in January 2026, the FDA reviewed the Company’s proposed analytical similarity strategy under the 351(k) biosimilar pathway and provided feedback supporting the Company’s planned analytical development
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AEON
News
- AEON Biopharma Appoints John Bencich as Chief Financial OfficerGlobeNewswire
- AEON Biopharma Abstract Accepted for Presentation at 2026 American Academy of Neurology (AAN) Annual MeetingGlobeNewswire
- AEON Biopharma Reports BPD Type 2a Meeting with FDA and Shareholder Approval of the November TransactionsGlobeNewswire
AEON
Sec Filings
- 3/11/26 - Form 4
- 3/9/26 - Form 8-K
- 3/5/26 - Form 4
- AEON's page on the SEC website