MoonLake Immunotherapeutics (NASDAQ:MLTX) secured a decisive regulatory win when the U.S. Food and Drug Administration (FDA) confirmed that the combined data from its VELA‑1, VELA‑2, and MIRA trials provide substantial evidence of effectiveness for sonelokimab in hidradenitis suppurativa (HS) and that no new pivotal study is required for a Biologics License Application (BLA). The decision was reached during a Type B meeting held on January 8 2026 and removes a key regulatory hurdle that had delayed the company’s launch plans.
The FDA’s guidance clarified that VELA‑2 data should be included in the marketing application to inform safety, but the agency will not require it for efficacy. VELA‑1 met all primary and key secondary endpoints, while VELA‑2 failed to reach statistical significance in its primary composite analysis due to a higher‑than‑expected placebo response. The MIRA trial, a phase 2b study, achieved a 43% response rate with a 29‑percentage‑point difference versus placebo. By allowing the company to rely on these existing data sets, the FDA has paved a clear path to a BLA submission in the second half of 2026.
The regulatory outcome is particularly meaningful in light of MoonLake’s September 2025 stock decline, when the market reacted sharply to the VELA‑2 setback. The company’s share price fell roughly 90% after the announcement that VELA‑2 had not met its primary endpoint. The FDA’s current decision effectively neutralizes that headwind by confirming that the safety data from VELA‑2 can still be leveraged, while the efficacy data from VELA‑1 and MIRA remain robust. This turnaround restores investor confidence and positions the company to move forward without the financial and time costs of a new trial.
Beyond the immediate regulatory benefit, the decision accelerates MoonLake’s ability to capture a sizable portion of the projected $15 billion HS market by 2035. The company also continues to advance sonelokimab in other inflammatory indications—psoriatic arthritis, axial spondyloarthritis, and palmoplantar pustulosis—where data readouts are expected throughout 2026. The BLA filing in the second half of 2026 will therefore be a pivotal milestone for both the HS program and the broader pipeline.
CEO Dr. Jorge Santos da Silva emphasized the clarity the FDA meeting has provided: “The feedback confirms that we can proceed with a BLA for HS without additional trials, giving us a clear path to approval and a stronger position in a high‑need market.” He added that the company will host an Investor Day on February 23 2026 to discuss the FDA outcome and upcoming milestones across its pipeline.
Investors have responded positively to the FDA’s decision, reflecting confidence in MoonLake’s ability to translate its clinical data into a marketable product and to advance its broader pipeline without the need for further costly studies.
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