MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmoplantar Pustulosis (PPP) and Provides Details on Upcoming Investor Day
MoonLake Immunotherapeutics - Class A Ordinary Shares (MLTX)
Company Research
Source: GlobeNewswire
The Dermatology Division of the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) in moderate-to-severe palmoplantar pustulosis (PPP) supported by positive results from the Phase 2 LEDA trialThe upcoming Phase 3 program will therefore be expected to benefit from earlier and more frequent interactions with the FDA under the Fast Track program, potentially enabling a more efficient development pathway This regulatory decision follows the recent clear guidance from the FDA, in which the Company confirmed its clinical evidence strategy for the planned submission of a Biologic License Application (BLA) in H2 2026 for SLK in hidradenitis suppurativa (HS)The PPP program will be discussed at the upcoming Investor Day webcast, confirmed for February 23, 2026, 8.00 – 9.30 am EST (2:00 – 3.30pm CET), including an open Q&A session The Company will also present the Phase 2 S-OLARIS readout in axial spondyloarthritis (axSpA) as the first in a series of
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News
- MoonLake Immunotherapeutics (NASDAQ:MLTX) was downgraded by analysts at Zacks Research from a "hold" rating to a "strong sell" rating.MarketBeat
- 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
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