Protalix BioTherapeutics and Chiesi Farmaceutici S.p.A to Apply for Accelerated Approval of pegunigalsidase alfa for the Treatment of Fabry Disease in the United States
Protalix BioTherapeutics, Inc. (DE) (PLX)
NASDAQ:AMEX Investor Relations:
phx.corporate-ir.net/phoenix.zhtml?c=101161&p=irol-irhome
Company Research
Source: GlobeNewswire
CARMIEL, Israel, June 06, 2019 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE American: PLX) (TASE: PLX), or Protalix, and Chiesi Farmaceutici S.p.A, an international research-focused healthcare Group, or Chiesi, today announced that, following a series of meetings and correspondence with the U.S. Food and Drug Administration (FDA), they plan to file a biologics license application, or a BLA, for pegunigalsidase alfa for the treatment of Fabry disease in the first quarter of 2020 via the FDA’s Accelerated Approval pathway. Over the last several months, Protalix and Chiesi have engaged the FDA in a dialogue regarding the potential eligibility of pegunigalsidase alfa for accelerated approval based on readily available data generated by Protalix from its clinical studies of pegunigalsidase alfa. As a result of this dialogue and a recent letter received from the FDA, Protalix and Chiesi have initiated preparations for a BLA submission based on data from the completed phase I
Show less
Read more
Impact Snapshot
Event Time:
PLX
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
PLX 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
PLX alerts
High impacting Protalix BioTherapeutics, Inc. (DE) news events
Weekly update
A roundup of the hottest topics
PLX
News
- Protalix BioTherapeutics, Inc. (NYSE: PLX) was upgraded by analysts at StockNews.com from a "buy" rating to a "strong-buy" rating.MarketBeat
- Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce Validation of Variation Submission by European Medicines Agency for pegunigalsidase alfa [Yahoo! Finance]Yahoo! Finance
- Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce Validation of Variation Submission by European Medicines Agency for pegunigalsidase alfaPR Newswire
- Chiesi Global Rare Diseases and Protalix BioTherapeutics Announce Validation of Variation Submission by European Medicines Agency for pegunigalsidase alfaPR Newswire
- Protalix BioTherapeutics, Inc. (NYSE: PLX) was upgraded by analysts at StockNews.com from a "hold" rating to a "buy" rating.MarketBeat
PLX
Earnings
- 11/14/24 - Miss
PLX
Sec Filings
- 11/14/24 - Form 10-Q
- 11/14/24 - Form 8-K
- 11/5/24 - Form 4/A
- PLX's page on the SEC website