Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA™ (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19
Invivyd, Inc. (IVVD)
Company Research
Source: GlobeNewswire
PEMGARDA (pemivibart) is authorized in the U.S. for PrEP of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise Emergency use authorization based on positive immunobridging data and on safety data from the CANOPY clinical trial along with ongoing in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1PEMGARDA is the first PrEP monoclonal antibody (mAb) to receive EUA from the U.S. FDA based on a novel, rapid, repeatable immunobridging trial design PEMGARDA is the first authorized mAb from Invivyd’s novel technology platform approach designed to address the challenge of rapid viral evolutionProduct availability in the U.S. anticipated imminentlyEstimated cash and cash equivalents of $200.6 million as of December 31, 2023 In February 2024, the Company sold shares totaling $40.5 million in gross proceeds under its At-the-Market facility further strengthening its balance sheet ahead of PEMGARDA launchConference call today at 4pm ET
Show less
Read more
Impact Snapshot
Event Time:
IVVD
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
IVVD 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
IVVD alerts
High impacting Invivyd, Inc. news events
Weekly update
A roundup of the hottest topics
IVVD
News
- Invivyd Receives Healthcare Common Procedure Coding System (HCPCS) Reimbursement Codes from the U.S. Centers for Medicare & Medicaid Services (CMS) Covering PEMGARDA™GlobeNewswire
- Invivyd Announces CEO TransitionGlobeNewswire
- We're Keeping An Eye On Invivyd's (NASDAQ:IVVD) Cash Burn Rate [Yahoo! Finance]Yahoo! Finance
- Invivyd, Inc. (NASDAQ: IVVD) was upgraded by analysts at Guggenheim from a "neutral" rating to a "buy" rating. They now have a $9.00 price target on the stock.MarketBeat
- Invivyd Provides PEMGARDA™ Launch Update and Announces 2024 Net Product Revenue Guidance in the Range of $150 Million to $200 Million [Yahoo! Finance]Yahoo! Finance
IVVD
Earnings
- 11/9/23 - Beat
IVVD
Sec Filings
- 4/22/24 - Form EFFECT
- 4/18/24 - Form ARS
- 4/18/24 - Form DEF
- IVVD's page on the SEC website