US Stock MarketDetailed Quotes
AEON AEON Biopharma
- 1.100
- +0.080+7.84%
Close Oct 16 16:00 ET
- 1.130
- +0.030+2.72%
Post 20:01 ET
43.47MMarket Cap-106P/E (TTM)
1.120High1.010Low143.74KVolume1.010Open1.020Pre Close154.24KTurnover0.82%Turnover RatioLossP/E (Static)39.52MShares17.17052wk High-1.56P/B19.30MFloat Cap0.63652wk Low--Dividend TTM17.55MShs Float17.170Historical High--Div YieldTTM10.78%Amplitude0.636Historical Low1.073Avg Price1Lot Size
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AEON Biopharma Stock Forum
AEON Biopharma Announces Positive Outcome From FDA Biosimilar Advisory Meeting
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...
– 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...
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