Zogenix Announces FDA Agreement to Proceed with Resubmission of FINTEPLA® NDA
Zogenix, Inc. (ZGNX)
Last zogenix, inc. earnings: 3/2 04:01 pm
Check Earnings Report
US:NASDAQ Investor Relations:
zogenixinc.gcs-web.com/investor-overview
Company Research
Source: GlobeNewswire
EMERYVILLE, Calif., June 27, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that following receipt of final minutes from the U.S. Food and Drug Administration (FDA) from the Type A meeting held on May 30, 2019, the Company intends to resubmit its New Drug Application (NDA) for FINTEPLA® (ZX008, fenfluramine) for the treatment of seizures associated with Dravet syndrome in the third quarter of this year. The Type A meeting was conducted to review the two issues identified in the Refusal to File (RTF) letter issued by the FDA on April 5, 2019: first, certain non-clinical studies were not submitted to allow assessment of the chronic administration of fenfluramine; and, second, the application contained an incorrect version of a clinical dataset. Based on the final meeting minutes received, the FDA has agreed to Zogenix’s plan to resubmit the NDA for FINTEPLA without the inclusion of the new chro
Show less
Read more
Impact Snapshot
Event Time:
ZGNX
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
ZGNX 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
ZGNX alerts
High impacting Zogenix, Inc. news events
Weekly update
A roundup of the hottest topics