Axogen Announces FDA Approval of Biologics License Application for AVANCE® (acellular nerve allograft–arwx)
Axogen, Inc. (AXGN)
Last axogen, inc. earnings: 2/24 04:01 pm
Check Earnings Report
US:NASDAQ Investor Relations:
ir.axogeninc.com
Company Research
Source: GlobeNewswire
ALACHUA, Fla. and TAMPA, Fla., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical technologies for the restoration of peripheral nerve function, today announced that the U.S. Food and Drug Administration (the “FDA”) has approved the Biologics License Application (“BLA”) for AVANCE® (acellular nerve allograft-arwx). Avance is an acellular nerve scaffold for the treatment of adult and pediatric patients aged 1 month or older with sensory, mixed, and motor peripheral nerve discontinuities. The indications for sensory nerve discontinuities 25mm and for mixed and motor nerve discontinuities were approved under FDA’s Accelerated Approval pathway based on the effect on static two-point discrimination in sensory nerve gaps =25mm, which provided empirical evidence to reasonably predict clinical benefit given similarities in pathophysiology and anticipated therapeutic effects. Continued approval for these indication
Show less
Read more
Impact Snapshot
Event Time:
AXGN
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
AXGN 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
AXGN alerts
High impacting Axogen, Inc. news events
Weekly update
A roundup of the hottest topics
AXGN
News
- AxoGen (NASDAQ:AXGN) was given a new $37.00 price target on by analysts at Canaccord Genuity Group Inc..MarketBeat
- AxoGen (NASDAQ:AXGN) had its "outperform" rating reaffirmed by analysts at Raymond James Financial, Inc..MarketBeat
- AxoGen (NASDAQ:AXGN) had its "buy" rating reaffirmed by analysts at Lake Street Capital.MarketBeat
- AxoGen (NASDAQ:AXGN) had its "buy" rating reaffirmed by analysts at Jefferies Financial Group Inc..MarketBeat
- Axogen Announces FDA Approval of Biologics License Application for AVANCE® (acellular nerve allograft–arwx) [Yahoo! Finance]Yahoo! Finance
AXGN
Earnings
- 10/29/25 - Beat
AXGN
Sec Filings
- 12/4/25 - Form 8-K
- 11/14/25 - Form SCHEDULE
- 11/12/25 - Form 144
- AXGN's page on the SEC website