Alnylam Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1 (PH1)
Alnylam Pharmaceuticals, Inc. (ALNY)
Last alnylam pharmaceuticals, inc. earnings: 2/6 08:00 am
Check Earnings Report
US:NASDAQ Investor Relations:
investors.alnylam.com/investor-overview
Company Research
Source: Business Wire
- Company Plans to Complete Submission in Early 2020 –– Lumasiran Granted Pediatric Rare Disease Designation by FDA for the Treatment of PH1 – CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the Company has initiated a rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for the treatment of primary hyperoxaluria type 1 (PH1). The rolling submission allows completed sections of an NDA to be reviewed by the FDA on an ongoing basis. Specifically, Alnylam has submitted the non-clinical components to the FDA and expects to submit the remaining components in early 2020. Alnylam also announced that it has been granted a pediatric rare disease designation from the FDA for lumasiran for the treatment of PH1.“Having recently announced positive topline results in the ILLUMINAT
Show less
Read more
Impact Snapshot
Event Time:
ALNY
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
ALNY 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
ALNY alerts
High impacting Alnylam Pharmaceuticals, Inc. news events
Weekly update
A roundup of the hottest topics
ALNY
News
- ProQR Nominates Martin Maier, PhD to Board and Announces Annual Meeting of Shareholders to be Held May 22, 2024 [Yahoo! Finance]Yahoo! Finance
- Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) was downgraded by analysts at StockNews.com from a "buy" rating to a "hold" rating.MarketBeat
- Gene Therapy: Non-Viral Vectors [Forbes]Forbes
- Alnylam to Webcast Conference Call Discussing First Quarter 2024 Financial ResultsBusiness Wire
- ALNY ALERT: Levi & Korsinsky Reminds Investors of an Investigation Involving Possible Securities Fraud Violations by Alnylam Pharmaceuticals, Inc.Accesswire
ALNY
Earnings
- 2/15/24 - Beat
ALNY
Sec Filings
- 4/1/24 - Form ARS
- 4/1/24 - Form DEFA14A
- 4/1/24 - Form DEF
- ALNY's page on the SEC website