NYSE American accepts AEON Biopharma plan, sets August 3, 2026 deadline

The notice

AEON Biopharma, Inc. (NYSE American: AEON) received a written notice of non-compliance from NYSE American, which the company disclosed in an 8-K filed on February 7, 2025. The notice said AEON was not in compliance with Sections 1003(a)(i), (ii) and (iii) of the NYSE American Company Guide. The company had to submit a plan by March 5, 2025 advising of actions taken or to be taken to regain compliance by August 3, 2026, and it did so. The 8-K does not say which financial measures those sections set or by how much the company fell short.

The acceptance

On April 22, 2025, the exchange sent an acceptance letter approving the plan and granting AEON until August 3, 2026 to regain compliance. During that plan period, NYSE American will review the company's progress against the goals and initiatives in the plan from time to time. AEON said it "intends to take all reasonable measures available" to regain compliance. The 8-K, signed on April 25, 2025 by Jost Fischer as interim chief executive officer, does not list those measures, and the plan itself is not attached.

If AEON does not regain compliance by August 3, 2026, or does not make sufficient progress consistent with the plan, NYSE American may begin delisting proceedings. The acceptance has no immediate effect on the listing. The Class A common stock continues to trade on NYSE American under the symbol AEON, subject to the exchange's other requirements. The company says the letter does not affect its business operations or its SEC reporting.

The company and its drug

AEON became a public company through a merger with Priveterra Acquisition Corp., a blank-check company, that closed on July 21, 2023. Its stock began trading on NYSE American on July 24, 2023. The 10-K for 2024, filed March 24, 2025, describes it as a clinical-stage company focused on ABP-450 (prabotulinumtoxinA), a botulinum toxin complex, for debilitating medical conditions, with an initial focus on neurosciences.

The 10-K says AEON's Phase 2 trials in episodic and chronic migraine did not meet their respective primary endpoints. In May 2024 the company announced it was discontinuing them to implement cash preservation measures. On July 9, 2024 it announced a strategic reprioritization toward a 351(k) biosimilar pathway, using AbbVie's Botox as the proposed reference product for all approved indications other than cosmetic uses. It held an initial FDA meeting in the third quarter of 2024, began analytical studies in the fourth quarter of 2024, and is preparing for a potential biosimilar development meeting with the FDA in the second half of 2025. The company cites an estimated $3.0 billion global therapeutic botulinum toxin market, which is its own market estimate.

ABP-450 is the same toxin complex that is approved as a biosimilar in Mexico and India and, in the United States, marketed for cosmetic use by Evolus, Inc. under the name Jeuveau. AEON holds exclusive development and distribution rights for certain therapeutic uses in the United States, Canada, the European Union, the United Kingdom and other territories. Its licensing partner is Daewoong. The company completed a Phase 2 study in cervical dystonia that enrolled 59 patients in a randomized, double-blind, placebo-controlled design with doses of 150 units, 250 units, 350 units or placebo. The 10-K gives no date for a U.S. filing or approval of the company's own product.

What the filings leave out

The 8-K and the 10-K business section give no balance sheet, cash figure or net loss for AEON, and no statement from the company on its share price or on the cause of the notice. Without those, the company's ability to meet the plan cannot be assessed. The compliance deadline is August 3, 2026.

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