CytoDyn Announces Productive Conference Call with FDA Regarding First BLA Submission for Leronlimab (PRO 140) Combination Therapy at 700 mg Dose
CYTODYN INC (CYDY)
NASDAQ:AMEX Investor Relations:
ir.cytodyn.com
Company Research
Source: GlobeNewswire
Successful interim results in the 700 mg monotherapy arm prompted the FDA to allow CytoDyn to switch all remaining combination therapy patients from CD02-Extension study from 350 mg to 700 mg dose CytoDyn is in negotiations for post-approval sales distribution channels with potential upfront payment to CytoDyn VANCOUVER, Washington, Feb. 01, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company developing new antibody therapies for combating human immunodeficiency virus (HIV) infection and potentially disrupting cancer metastasis, announces that it had a productive conference call meeting with the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) submission. This was the first follow-up meeting since its June 2018 pre-BLA meeting regarding the Company’s planned submission of its BLA and the positive interim data of its 700 mg monotherapy trial. The FDA recognized that the higher dosage of 700 mg in the monotherapy tria
Show less
Read more
Impact Snapshot
Event Time:
CYDY
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
CYDY 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
CYDY alerts
High impacting CYTODYN INC news events
Weekly update
A roundup of the hottest topics
CYDY
News
- CytoDyn Announces FDA Has Lifted Clinical Hold [Yahoo! Finance]Yahoo! Finance
- CytoDyn Announces FDA Has Lifted Clinical HoldGlobeNewswire
- CytoDyn Announces Submission of Clinical Protocol to FDA and Initiation of Pre-Clinical Study in Glioblastoma [Yahoo! Finance]Yahoo! Finance
- CytoDyn Announces Submission of Clinical Protocol to FDA and Initiation of Pre-Clinical Study in GlioblastomaGlobeNewswire
- CytoDyn Appoints Jacob Lalezari M.D. as CEO, Mitchell Cohen as Interim CFO [Yahoo! Finance]Yahoo! Finance
CYDY
Sec Filings
- 4/16/24 - Form 424B3
- 4/16/24 - Form 424B3
- 4/15/24 - Form 10-Q
- CYDY's page on the SEC website