MoonLake Immunotherapeutics Announces Positive Feedback from both FDA and EMA on Regulatory Path for the Phase 3 Program of the Nanobody® sonelokimab (SLK) in Hidradenitis Suppurativa (HS)...
MoonLake Immunotherapeutics - Class A Ordinary Shares (MLTX)
Company Research
Source: Yahoo! Finance
Clarified path for HS Phase 3 program with study design, patient population and endpoints agreed One dose of SLK (120mg) to be tested with a similar protocol as in Phase 2 Total Phase 3 population of 800 patients to be complemented by Phase 2 population for registration Phase 3 trial has similar design to validated Phase 2 trial and in line with the Company's communications and expectations First patient expected to be randomized in Q2 2024, primary endpoint readout expected mid-2025 Further details to be provided in upcoming R&D Day ZUG, Switzerland, February 26, 2024 – MoonLake Immunotherapeutics (NASDAQ:MLTX) (“MoonLake”), a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced the successful outcome of its end-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA), as well as positive feedback from its interactions with the E.U. European Medicines Agency (EMA), with both regulatory bo
Show less
Read more
Impact Snapshot
Event Time:
MLTX
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
MLTX 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
MLTX alerts
High impacting MoonLake Immunotherapeutics - Class A Ordinary Shares news events
Weekly update
A roundup of the hottest topics
MLTX
News
- MoonLake Immunotherapeutics (NASDAQ: MLTX) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $100.00 price target on the stock.MarketBeat
- MoonLake Immunotherapeutics (NASDAQ: MLTX) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $100.00 price target on the stock.MarketBeat
- MoonLake Immunotherapeutics Inks Three-Year Technology Partnership With Komodo Health To Advance Research on Inflammatory Skin and Joint Conditions [Yahoo! Finance]Yahoo! Finance
- MoonLake Immunotherapeutics Inks Three-Year Technology Partnership With Komodo Health To Advance Research on Inflammatory Skin and Joint ConditionsBusiness Wire
- MoonLake Immunotherapeutics inks three-year technology partnership with Komodo Health to advance research on inflammatory skin and joint conditions GlobeNewswire
MLTX
Sec Filings
- 4/24/24 - Form DEFA14A
- 4/24/24 - Form ARS
- 4/24/24 - Form DEF
- MLTX's page on the SEC website