AEON Biopharma Stock Forum

$AEON Biopharma (AEON.US)$ Reuters· 2 mins ago
AEON Biopharma Announces Positive Outcome From FDA Biosimilar Advisory Meeting

$AEON Biopharma (AEON.US)$
AEON Biopharma Announces Positive Outcome from FDA Biosimilar Advisory Meeting
– Company is aligned with the FDA 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 –
– Comparative analytical studies anticipated to commence in Q4 2024 –
– Expect to conduct a Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA in 2025 to review...

$AEON Biopharma (AEON.US)$ AEON Biopharma Reports Second Quarter 2024 Financial Results and Provides Corporate Update
– Progressing plans to develop ABP-450 (prabotulinumtoxinA) injection as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product –
– Scheduled to hold a biosimilar initial advisory meeting with FDA in 3Q 2024 –
– 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...