Advaxis’ Phase 3 AIM2CERV Study Placed on Partial Clinical Hold by FDA Related to CMC Requests
Advaxis, Inc. (ADXS)
Last advaxis, inc. earnings: 9/9 08:00 am
Check Earnings Report
US:NASDAQ Investor Relations:
ir.advaxis.com
Company Research
Source: Business Wire
Enrolled Patients Continue to be Treated PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, today announced receipt of notification from the U.S. Food and Drug Administration (FDA) that the Company’s ongoing Phase 3, randomized, double-blinded, placebo-controlled, pivotal study of axalimogene filolisbac (AXAL) in high-risk, locally advanced cervical cancer (AIM2CERV) has been placed on partial clinical hold. The FDA’s recent communication, received late last week, states that the partial hold is related to their requests for additional information pertaining to certain AXAL chemistry, manufacturing and controls (CMC) matters. The Agency did not cite any safety issues related to the trial and all currently enrolled patients will continue to receive treatment, per the
Show less
Read more
Impact Snapshot
Event Time:
ADXS
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
ADXS 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
ADXS alerts
High impacting Advaxis, Inc. news events
Weekly update
A roundup of the hottest topics
ADXS
News
- Ayala Pharmaceuticals, Inc. (NASDAQ: ADXS) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Ayala Pharmaceuticals, Inc. (NASDAQ: ADXS) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Ayala Pharmaceuticals, Inc. (NASDAQ: ADXS) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Ayala Pharmaceuticals, Inc. (NASDAQ: ADXS) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Ayala Pharmaceuticals, Inc. (NASDAQ: ADXS) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
ADXS
Sec Filings
- 4/19/24 - Form 8-K/A
- 4/16/24 - Form 10-K
- 4/15/24 - Form S-8
- ADXS's page on the SEC website