MoonLake Immunotherapeutics (NASDAQ:MLTX) on Thursday received U.S. Food and Drug Administration (FDA) feedback regarding the clinical evidence strategy for Sonelokimab (SLK) in Hidradenitis Suppurativa (HS), based on the Type B meeting requested by MoonLake.
SLK was associated with significant improvements across different key outcomes in over 1,000 patients with HS enrolled in the MIRA, VELA-1, and VELA-2 trials.
Data
MIRA trial data demonstrated a 43% response with 120mg SLK, and a 29 ppt delta vs placebo (p < 0.001) at week 12.
VELA-1 met all primary and key secondary endpoints with statistical significance across all pre-specified analysis strategies.
In VELA-2, SLK achieved statistical significance (36% response with 120mg SLK at week 16, delta to placebo of 10ppt, p = 0.033). A higher-than-expected placebo response precluded this study from achieving statistical significance using the primary composite analysis method (delta to placebo of 9%, p=0.053).
What Next?
To obtain regulatory clarity following the VELA readout and to continue the preparation of the BLA, MoonLake requested a Type B meeting with the FDA.
The FDA indicated that MoonLake may establish substantial evidence of effectiveness without additional clinical trials in HS.
In addition, the FDA advised the company that the results of the VELA-2 trial should be submitted for the marketing application to inform the safety of SLK, regardless of decisions on its utility in establishing effectiveness.
MoonLake will continue its planned preparations for BLA submission, which is on track for the second half of 2026.
In June 2025, U.S. drug giant Merck & Co. Inc. (NYSE:MRK) reportedly approached MoonLake Immunotherapeutics with a bid exceeding $3 billion.
Price Action: MLTX stock is up 27.55% at $14.40 at the last check on Thursday.
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