AEON Biopharma Announces Positive Outcome from FDA Biosimilar Advisory Meeting
AEON Biopharma, Inc. Class A (AEON)
Company Research
Source: GlobeNewswire
– 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 the results from the analytical studies and confirm remainder of proposed study package – IRVINE, Calif., Sept. 30, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway, today announced receipt of the formal minutes from a recent Biosimilar Initial Advisory (BIA) Meeting with the U.S. Food and Drug Administration (FDA) for ABP-450 (prabotulinumtoxinA) injection as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product. The
Show less
Read more
Impact Snapshot
Event Time:
AEON
Last Price
Price Change
Price Change%
Volume Shares
Max Up
Max Down
%
Volume Ratio
Performance Comparison
Updated
|
Event Day
Stock performance from the time of news release until the following 4pm ET market close
|
Last price at news event
|
Since Event
Multi-day stock performance from the time of the news release
|
|---|---|---|
|
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
|
LAST
PRICE AT NEWS EVENT |
SINCE EVENT
Multi-day stock performance from the time of the news release
|
| Last Price | ||
| VWAP | ||
|
High:
|
Max Up |
High:
|
|
Low:
|
Max Down |
Low:
|
|
%
|
Post news range |
%
|
|
|
Price change |
|
|
|
Price Change Percentage |
|
|
|
S&P 500 (SPX) |
|
|
%
|
Volume ratio |
%
|
| Volume | ||
| Ticks | ||
|
|
Avg transaction size |
|
Don't Miss Out On The Next BIG Stock Move
Event day
Event Day Chart will not be displayed beyond 90-day period of the event
Performance since event
Time And Velocity Analysis
Be the first to know
Opt in for alerts from News Quantifed
Sign Up Today
Opt-in for
AEON alerts
Learn More With NQ
Reading the Impact Report
Help Me Understand This Data
Help Me Understand This Data
How NQ Works
What is news-based trading?
And why is it so successful?
And why is it so successful?
Movers & Shakers
The biggest gainers and losers and WHY it moved
AEON alerts
High impacting AEON Biopharma, Inc. Class A news events
Weekly update
A roundup of the hottest topics
AEON
News
- AEON Biopharma, Inc. (NASDAQ: AEON) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $5.00 price target on the stock.MarketBeat
- AEON Biopharma to Participate in the H.C. Wainwright 26th Annual Global Investment Conference 2024GlobeNewswire
- AEON Biopharma, Inc. (NASDAQ: AEON) had its price target lowered by analysts at HC Wainwright from $6.00 to $5.00. They now have a "buy" rating on the stock.MarketBeat
- AEON Biopharma Reports Second Quarter 2024 Financial Results and Provides Corporate UpdateGlobeNewswire
AEON
Analyst Actions
- 10/1/24 - HC Wainwright
AEON
Sec Filings
- 10/7/24 - Form 8-K
- 9/10/24 - Form 4/A
- 9/4/24 - Form 4
- AEON's page on the SEC website