MoonLake Immunotherapeutics (NASDAQ:MLTX) experienced a significant boost in stock value following positive feedback from the U.S. Food and Drug Administration (FDA) regarding its treatment for Hidradenitis Suppurativa (HS). The FDA indicated that MoonLake may be able to file for marketing approval for its drug, Sonelokimab (SLK), without the need for additional clinical trials.
The feedback was delivered during a Type B meeting requested by MoonLake, aimed at clarifying the clinical evidence strategy for SLK. This treatment has shown promising results across multiple trials involving over 1,000 patients. Notably, data from the MIRA trial indicated a 43% response rate with a 120 mg dose of SLK, surpassing the placebo by 29 percentage points (p < 0.001) at week 12. The VELA-1 trial also met all primary and key secondary endpoints with statistical significance across various analysis strategies. In the VELA-2 trial, SLK demonstrated a 36% response rate at week 16, showing a 10 percentage point improvement over placebo (p = 0.033). However, the study faced challenges, as a higher-than-expected placebo response limited its statistical significance when evaluated through the primary composite analysis method, yielding a 9% delta to placebo (p = 0.053).
Regulatory Clarity and Future Steps
Following the readout from the VELA trials, MoonLake sought regulatory clarity from the FDA. The agency’s feedback suggested that substantial evidence of SLK’s effectiveness could be established without further clinical trials. Additionally, the FDA advised that results from the VELA-2 trial should be included in the upcoming marketing application to address safety considerations, regardless of the trial’s effectiveness outcomes.
MoonLake is now focused on preparing its Biologics License Application (BLA), which is scheduled for submission in the second half of 2026. This timeline aligns with the company’s ongoing development goals and aims to ensure that all necessary data is submitted to support the application.
Market Reaction and Future Prospects
The market responded positively to this news, with MLTX shares soaring by 27.55% to reach $14.40 during Thursday’s trading session. This surge reflects investor confidence in the potential approval of SLK and its implications for treating HS.
In a noteworthy development, reports indicate that U.S. pharmaceutical giant Merck & Co. Inc. (NYSE:MRK) approached MoonLake with a bid exceeding $3 billion in June 2025. This potential acquisition underscores the growing interest in MoonLake’s innovative therapies and their impact on the biopharmaceutical market.
As MoonLake Immunotherapeutics advances towards its BLA submission and explores potential partnerships, the company remains committed to addressing the needs of patients suffering from Hidradenitis Suppurativa and enhancing its position in the competitive landscape of immunotherapeutic treatments.
