MLTX MoonLake

sonelokimab · NCT06641089 registry update

status: RECRUITING → ACTIVE_NOT_RECRUITING; primary_completion: 2027-01-15 → 2027-01-04; completion: 2027-01-15 → 2027-09-13

MoonLake submits BLA for sonelokimab in hidradenitis suppurativa

MoonLake Immunotherapeutics submitted a Biologics License Application to the FDA seeking approval of sonelokimab for moderate-to-severe hidradenitis suppurativa in adults and pediatric patients 12 years and older. The company expects notification of BLA acceptance within ~60 days and the planned review timeline within ~74 days.

MoonLake reports Week 52 VELA Phase 3 data for sonelokimab in HS

Phase 3 VELA-1 and VELA-2 trials met their long-term endpoints with 67.2% HiSCR75 and 33.1% HiSCR100 at Week 52. Adolescent VELA-TEEN data showed ~68% HiSCR75 at Week 24. Company confirms BLA submission planned for end of September 2026.

MoonLake: FDA aligns on pre-BLA plans for sonelokimab in HS

The 8-K discloses that MoonLake completed its final pre-BLA meeting with the FDA and reached alignment on submission plans and label strategy for sonelokimab in hidradenitis suppurativa. This regulatory milestone clears the path for the company to proceed with its planned BLA filing for the asset.

MoonLake SLK positive pre-BLA meeting outcome for HS

MoonLake completed its final pre-BLA meeting with FDA on April 1, 2026 for the HS program of SLK. The meeting outcome was positive, clearing the path for a planned BLA submission.

MoonLake schedules FDA Type B meeting for sonelokimab HS BLA package

MoonLake confirmed a Type B meeting with the FDA on December 15, 2025 to discuss whether the current clinical evidence package from the VELA-1 and VELA-2 trials is adequate to support a BLA submission for sonelokimab in hidradenitis suppurativa. The meeting outcome will determine the regulatory path and timing for the planned Q3/Q4 2026 BLA filing.