MoonLake Immunotherapeutics (MLTX) got some very welcome news from regulators on Thursday. Following a Type B meeting with the U.S. Food and Drug Administration, the agency indicated that the biotech company may be able to establish substantial evidence of effectiveness for its drug Sonelokimab (SLK) in treating Hidradenitis Suppurativa (HS) without running additional clinical trials.
That's a big deal for MoonLake, which has been working toward a biologics license application submission. The FDA's feedback essentially validates the strength of the clinical data the company has already generated across three major studies involving over 1,000 patients with HS, a chronic and painful skin condition.
The Clinical Evidence
Sonelokimab demonstrated significant improvements across different key outcomes in the MIRA, VELA-1, and VELA-2 trials. The MIRA trial showed particularly strong results, with a 43% response rate using the 120mg dose of SLK and a 29 percentage point improvement versus placebo at week 12 (p < 0.001).
VELA-1 hit all primary and key secondary endpoints with statistical significance across all pre-specified analysis strategies, which is exactly what you want to see in a pivotal trial.
VELA-2 was a bit more complicated. The study achieved statistical significance with a 36% response rate for the 120mg dose at week 16 and a 10 percentage point improvement over placebo (p = 0.033). However, a higher-than-expected placebo response prevented the study from hitting statistical significance using the primary composite analysis method, which showed a 9% improvement over placebo (p=0.053).
What Happens Now
After getting the VELA readout, MoonLake requested the Type B meeting with the FDA to obtain regulatory clarity and continue preparing its biologics license application. The agency also advised that the VELA-2 trial results should be included in the marketing application to help inform the safety profile of Sonelokimab, regardless of whether those results are used to establish effectiveness.
The company is continuing its planned preparations for the BLA submission, which remains on track for the second half of 2026.
It's worth noting that Merck & Co. Inc (MRK) reportedly approached MoonLake in June 2025 with a bid exceeding $3 billion, suggesting significant industry interest in the drug's commercial potential.
Price Action: MLTX stock jumped 27.55% to $14.40 on Thursday.
