Key Takeaways
MoonLake Immunotherapeutics (NASDAQ: MLTX) will submit its sonelokimab drug for U.S. approval to treat hidradenitis suppurativa by the end of September 2026 after a positive final meeting with the Food and Drug Administration.
"With no remaining gaps identified, the pre-BLA process for HS is complete," the company said in a statement, confirming alignment with the FDA on the submission strategy for adults and adolescents.
The submission is supported by the Phase 2 MIRA trial, where sonelokimab achieved a ~43% response rate on the HiSCR75 measure, a key metric for HS clinical trials. This result was approximately 29 percentage points higher than placebo. The company also plans to apply for a Priority Review.
A potential U.S. launch in the second half of 2027 would give MoonLake access to the hidradenitis suppurativa market, which is projected to reach $15 billion by 2035. The company reported a cash balance of $357.9 million, sufficient to fund operations to the end of 2027.
For the first quarter ended March 31, 2026, MoonLake reported research and development expenses of $54.5 million, nearly flat from the prior quarter. General and administrative expenses rose to $15.5 million from $9.2 million in the fourth quarter of 2025, which the company attributed primarily to a $4.8 million accelerated expense from the cancellation of unvested stock options.
The successful FDA meeting clears a major regulatory hurdle for sonelokimab in HS. Investors will now look to a series of upcoming clinical data readouts in 2026, including 52-week data from the Phase 3 VELA trials in HS during the second quarter and primary endpoint data from the Phase 3 IZAR-1 trial in psoriatic arthritis in mid-2026.
This article is for informational purposes only and does not constitute investment advice.
