MoonLake Immunotherapeutics (NASDAQ:MLTX) jumped about 25% on Thursday after the company disclosed encouraging regulatory feedback from the U.S. Food and Drug Administration regarding Sonelokimab (SLK) for the treatment of Hidradenitis Suppurativa (HS).
Following a Type B meeting, the FDA indicated that MoonLake may be able to demonstrate substantial evidence of effectiveness for SLK in HS without conducting additional clinical trials. The agency advised that results from the existing MIRA study should be included in the Biologics License Application (BLA), while data from the VELA-2 trial should be submitted to support the product’s safety profile.
On the back of this guidance, MoonLake said it intends to file its BLA for SLK in HS in the second half of 2026. The company sought the Type B meeting to gain regulatory clarity and align with the FDA on the clinical evidence strategy supporting the application.
Commenting on the development, founder and chief executive officer Dr. Jorge Santos da Silva said: “The positive outcome of our Type B meeting with the FDA provides the clarity needed to support a pathway to approval for our existing HS program, with no additional clinical trials required.”
Across more than 1,000 HS patients enrolled in the MIRA, VELA-1 and VELA-2 studies, SLK delivered meaningful improvements across key clinical endpoints. In the MIRA trial, the 120mg dose achieved a 43% response rate, representing a 29 percentage point improvement versus placebo.
The Zug, Switzerland-based biotech company said it will host an Investor Day on February 23, 2026, to provide further detail on the FDA’s feedback and to present additional clinical data for SLK across multiple indications.
MoonLake also noted continued progress across its broader clinical programme, with data expected over the next 12 months from the Phase 2 S-OLARIS trial in Axial Spondyloarthritis and the Phase 3 IZAR studies in Psoriatic Arthritis, among other ongoing trials.