New York, Jan 8, 2026, 17:06 EST — After-hours
- MoonLake Immunotherapeutics shares rose 27% in late trading after the company disclosed FDA feedback on its lead program
- Company said the agency sees a potential approval package for sonelokimab in hidradenitis suppurativa using existing trial data
- Next focus shifts to a Feb. 23 investor day and a string of trial readouts the company flagged for 2026
MoonLake Immunotherapeutics shares jumped 27% to $14.34 on Thursday after the biotech said U.S. regulators supported a route to file its hidradenitis suppurativa treatment without doing more trials for the skin disease. The stock churned between $11.20 and $17.28, and roughly 24 million shares traded.
The update is a big deal because it clears up a near-term unknown: whether MoonLake would need to pay for and run another late-stage study before it can seek approval. For a clinical-stage company with no product revenue, that sort of timing decision can jolt the stock far more than the trial’s finer details.
MoonLake said the Food and Drug Administration told it in a Type B meeting that the company could potentially meet the agency’s “substantial evidence of effectiveness” standard for approval using results already in hand from its MIRA, VELA-1 and VELA-2 studies. Chief executive Jorge Santos da Silva said the meeting “provides the clarity needed to support a pathway to approval for our existing HS program, with no additional clinical trials required.” SEC
In its update, the company flagged HiSCR75 results — an endpoint calling for at least a 75% drop in abscess and inflammatory nodule count — as the key readout in its HS program. Chief scientific officer Kristian Reich said the existing trials “provide a basis for BLA submission,” and the company again said it plans to file a Biologics License Application — the filing used to seek approval for a biologic drug — in the second half of 2026. Nasdaq
A filing said MoonLake will hold an investor day on Feb. 23, laying out the FDA feedback and putting out new clinical data across indications. SEC
Hidradenitis suppurativa is still hard to control, and a full response remains out of reach for plenty of patients. The trials aren’t simple either, particularly when placebo responses run hot. MoonLake has leaned on the tougher HiSCR75 endpoint, arguing that any real benefit should be easier to spot, provided the effect holds up with longer follow-up. Dermatology Times
Thursday’s jump didn’t rewrite the story. MoonLake shares are still far below their 52-week high. Over the past year, the stock has lurched between $5.95 and $62.75, according to market data. Yahoo Finance
That still leaves plenty of regulatory hurdles. The FDA has to comb through the full application package, factor in longer-term data, and keep an eye out for any safety signals. And its take on the mixed late-stage record could still reshape the label — or prompt the agency to ask for more work.
Investors have one hard date circled: Feb. 23. Management plans to use it to spell out details from the FDA meeting, and to run through the 2026 catalyst calendar.
