Aeon Biopharma Advances Biosimilar Development

Aeon Biopharma, Inc. ( (AEON) ) has released its Q2 earnings. Here is a breakdown of the information Aeon Biopharma, Inc. presented to its investors.

Aeon Biopharma, Inc. is a biopharmaceutical company focused on developing ABP-450 as a biosimilar to BOTOX for therapeutic neurotoxin applications, aiming to enter the U.S. market with a full-label approval.

In its second-quarter 2025 earnings report, Aeon Biopharma highlighted significant progress in its biosimilar development efforts, with key milestones anticipated in the latter half of the year. The company is preparing for a crucial Type 2a meeting with the FDA in the fourth quarter, which will be pivotal for its development path.

The company reported cash and cash equivalents of $8.4 million, expected to support operations through the upcoming FDA meeting. Aeon is advancing its ABP-450 biosimilar development through a comparative analytical assessment, with primary structure and select functional analyses expected to be completed in the third quarter. These efforts are aligned with the FDA’s requirements and are supported by preclinical data from its partner, Daewoong Pharmaceutical.

Aeon Biopharma’s strategic focus remains on leveraging the 351(k) pathway to bring ABP-450 to the U.S. market, potentially offering a cost-effective alternative to the existing $3 billion therapeutic neurotoxin market dominated by a single product. The company believes this could enhance patient access and improve economic outcomes for healthcare stakeholders.

Looking ahead, Aeon Biopharma is poised to refine its guidance and confidently advance into the next phase of development, with the upcoming FDA meeting expected to provide clarity on its regulatory path forward.