FDA Confirms SLK BLA Path Using Existing Data, Easing Key Regulatory Risk

What happened

MoonLake announced positive FDA feedback from a Type B meeting, confirming that sonelokimab (SLK) for Hidradenitis Suppurativa (HS) can establish substantial evidence of effectiveness without additional trials, using data from VELA-1, VELA-2, and MIRA. This directly addresses the critical regulatory uncertainty highlighted in the DeepValue report, which stemmed from mixed Phase 3 results and questions over pooled analyses acceptance. The FDA advised including MIRA for efficacy and VELA-2 for safety, supporting MoonLake's plan to submit a Biologic License Application in H2 2026. However, this positive development does not eliminate liquidity concerns, with the company having near-zero cash as of mid-2025, or competitive pressures in HS. An Investor Day in February 2026 will offer more details, but investors must remain wary of execution risks and the need for favorable outcomes in other indications.

Implication

This feedback significantly de-risks the regulatory pathway for SLK in HS, a primary swing factor in the investment thesis, potentially preventing costly additional trials. By accepting existing data, the FDA validates MoonLake's strategy, which could accelerate commercialization and improve risk/reward dynamics. However, the company's precarious cash position raises execution risk for BLA submission and beyond, necessitating close monitoring of financing events. Competitive intensity in HS remains high with approved therapies like bimekizumab, underscoring the need for strong clinical differentiation in upcoming data. Investors should use the Investor Day to assess new insights and updates on capital allocation, but overall implications are positive yet tempered by broader operational hurdles.

Thesis delta

The DeepValue report's HOLD/NEUTRAL stance was dominated by regulatory risk; this FDA feedback directly mitigates that, shifting the thesis towards a more favorable regulatory outlook. However, the upgrade is limited by ongoing liquidity concerns and the need for positive outcomes in other indications, maintaining a cautious but improved risk/reward profile pending further execution milestones.