AEON Biopharma Reports Third Quarter 2024 Financial Results and Provides Corporate Update
AEON Biopharma(AEON) GlobeNewswire News Room·2024-11-14 05:05
– Held biosimilar advisory meeting with FDA in Q3 2024, and aligned on next steps for a 351(k) regulatory pathway to approval for ABP-450 (prabotulinumtoxinA) as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product – – Plan to initiate comparative analytical studies anticipated in Q4 2024 subject to available resources – – 351(k) regulatory pathway offers potential to bring ABP-450 to the U.S. market under a single approval for all of BOTOX’s currently approved and future therapeutic ...