Aeon Biopharma Inc（AEON）資訊與事件AEONAeon Biopharma Inc

Aeon Biopharma Submits IND Application to FDA

Aeon Biopharma announced the submission of an investigational new drug, or IND, application to the FDA for a comparative pharmacodynamic study utilizing compound muscle action potential measurements. The submission follows AEON's recently completed Biosimilar Biological Product Development Type 2b meeting with the FDA and represents continued progress in advancing the company's strategy to develop an integrated totality-of-evidence package under the 351(k) biosimilar regulatory pathway.

AEON Biopharma Receives FDA Meeting Minutes

AEON Biopharma announced receipt of the official minutes from its Biosimilar Biological Product Development Type 2b meeting held with the U.S. Food and Drug Administration regarding ABP-450's development pathway. "The Type 2b meeting feedback provides greater clarity on the development pathway for ABP-450 and, consistent with FDA's recent biosimilar guidance, supports a potentially more efficient clinical development program," said Rob Bancroft, President and Chief Executive Officer of AEON. "Our strategy is to bring together the most sensitive, complementary and relevant evidence available, including our analytical program, comparative human pharmacodynamic data and the substantial comparative human experience already generated with ABP-450."

Aeon Biopharma Appoints Paul Lee as Acting Chief Regulatory Officer

Aeon Biopharma announced the designation of Paul Lee as the company's acting chief regulatory officer, through Clintrex. Lee and Clintrex currently advise Aeon on the regulatory and clinical development strategy for ABP-450, providing strategic guidance as the company advances its biosimilar development program. In his acting chief regulatory officer role, Lee will lead Aeon's regulatory strategy, help guide the company's interactions with the FDA and work closely with Aeon's analytical, CMC and clinical teams as it advances ABP-450 under the 351 biosimilar pathway.