MoonLake Immunotherapeutics Announces Positive Outcome from Type B Meeting with U.S. FDA and Announces Investor Day
MoonLake Immunotherapeutics - Class A Ordinary Shares (MLTX)
Company Research
Source: GlobeNewswire
MoonLake requested a Type B meeting with the U.S. Food and Drug Administration (FDA) to obtain regulatory clarity and discuss the clinical evidence strategy for submission of a Biologic License Application (BLA) for Sonelokimab (SLK) in Hidradenitis Suppurativa (HS)FDA feedback confirms that the Company may establish substantial evidence of effectiveness (SEE), without additional clinical trials in HS, with a BLA consisting of data from its existing VELA-1, VELA-2 and MIRA trials The FDA specifically advised the Company to include the results of the MIRA trial in the submission and to submit the results of the VELA-2 trial for the marketing application to inform the safety profile of SLK, regardless of decisions on its utility in establishing SEEBased on the positive final official records of this Type B meeting MoonLake will continue its plans for BLA submission for SLK in HS in H2 2026An Investor Day to further discuss FDA feedback and value opportunities for SLK in HS and to share
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) was downgraded by analysts at The Goldman Sachs Group, Inc. from a "mixed" rating to a "sell" rating.MarketBeat
- MoonLake Immunotherapeutics (NASDAQ:MLTX) was given a new $24.00 price target on by analysts at UBS Group AG.MarketBeat
- MoonLake Immunotherapeutics (NASDAQ:MLTX) had its "buy" rating reaffirmed by analysts at HC Wainwright. They now have a $32.00 price target on the stock, up previously from $26.00.MarketBeat
- MoonLake Immunotherapeutics (NASDAQ:MLTX) was upgraded by analysts at BTIG Research from a "neutral" rating to a "buy" rating.MarketBeat
- MoonLake Immunotherapeutics (NASDAQ:MLTX) had its "buy" rating reaffirmed by analysts at UBS Group AG.MarketBeat
MLTX
Earnings
- 11/5/25 - Miss
MLTX
Sec Filings
- 1/9/26 - Form 4
- 1/9/26 - Form 4
- 1/9/26 - Form 4
- MLTX's page on the SEC website