MoonLake Immunotherapeutics Stock Draws Buzz After Skin Drug’s Phase 3 Trial Data — Retail Speculates Buyout, Bigger Gains
MoonLake said it plans to discuss the Phase 3 results with regulators to confirm the path toward approval of sonelokimab for hidradenitis suppurativa, with 52-week data expected in the second quarter of 2026.
Retail chatter spiked for MoonLake Immunotherapeutics late on Sunday after the company announced week 16 results from its Phase 3 VELA-1 and VELA-2 trials of sonelokimab in patients with moderate to severe hidradenitis suppurativa (HS).
The stock closed at $61.99 on Friday, up 10%, but fell 19% to $50.40 in overnight trading.
MoonLake said it plans to discuss the results with regulators to confirm the path toward approval of sonelokimab for HS. The 52-week data is expected to be released in the second quarter of 2026.
The company stated that both trials achieved their primary and key secondary goals when data were analyzed using a pre-specified treatment policy method. The studies compared sonelokimab with a placebo, using the HS Clinical Response 75 measure. This measure represents a 75% reduction in abscesses and inflamed nodules with no worsening in draining tunnels.
In VELA-1, patients treated with sonelokimab achieved a 17% higher response rate compared to those receiving placebo. In VELA-2, the difference was 9% under the composite analysis. Using the treatment policy approach, both trials showed statistically significant results. The response rates were 35% and 36% for sonelokimab compared with 18% and 26% for placebo.
“The higher-than-expected placebo response rate in VELA-2 is disappointing, but we are encouraged by the consistent performance of sonelokimab arms across all endpoints in both studies,” said Kristian Reich, Founder and Chief Scientific Officer at MoonLake.
Following the announcement, Stifel downgraded MoonLake to ‘Hold’ from ‘Buy’ and cut its price target to $13 from $77, saying the Phase 3 results were “significantly worse than expected.” Analyst Alex Thompson said the firm’s prior base case of a “clear path to approval in this large market is now off the table in the near term.” Stifel also lowered its probability of success for sonelokimab in hidradenitis suppurativa to 33% from 75%.
MoonLake stated that key secondary measures, including pain reduction, quality-of-life improvement, and HiSCR50 responses, also achieved statistical significance. Around 60% of patients treated with sonelokimab experienced a meaningful improvement of at least four points in the Dermatology Life Quality Index (DLQI).
The company added sonelokimab’s safety profile remained favorable with no new safety signals. Side effects were mainly mild nasal inflammation and headache. No suicidal ideation, liver issues, or major heart problems were reported.
All patients will continue receiving treatment until week 52, followed by an open-label extension lasting up to two years.
MoonLake said that other studies of sonelokimab are ongoing. These include the Phase 3 VELA-TEEN trial in adolescent HS, the IZAR program in psoriatic arthritis, and the S-OLARIS and LEDA trials in other inflammatory diseases.
On Stocktwits, retail sentiment was ‘extremely bullish’ amid ‘extremely high’ message volume, placing the stock among the top three trending equities on the platform.
One user said they had heard talk of a possible Merck buyout for MoonLake Immunotherapeutics that could be discussed during the company’s upcoming call, adding that “lots [was] happening in the offices today.”
Another user commented that investors were “being dramatic” about the data and said they would buy on the dip if they weren’t already fully invested, predicting that the stock “will dip but will bounce back later.”
MoonLake’s stock has risen 14.5% so far in 2025.
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