MoonLake Surges Over 27% on Positive FDA Signal for Skin Drug
Regulator indicates a path for approval of Sonelokimab for hidradenitis suppurativa without new Phase 3 trials, a major boon for the biotech firm.
Shares of MoonLake Immunotherapeutics (NASDAQ: MLTX) soared in Tuesday trading after the clinical-stage biotechnology company announced it had received favorable guidance from the U.S. Food and Drug Administration (FDA) for its lead asset, Sonelokimab.
The stock climbed by more than 27% to $14.41 after the company disclosed that the FDA has signaled a potential path to a Biologics License Application (BLA) for the treatment of hidradenitis suppurativa (HS) that would not require new, lengthy Phase 3 studies. This development could significantly de-risk and accelerate the timeline for bringing the novel treatment to market. The company confirmed it remains on track for a 2026 submission.
Hidradenitis suppurativa is a chronic, inflammatory skin disease that causes painful lumps and abscesses. The condition has been notoriously difficult to treat, and new therapeutic options are in high demand. For MoonLake, the FDA's feedback is a significant validation of its clinical program.
The guidance stems from minutes provided by the FDA following an End-of-Phase-2 meeting. The regulator indicated that the existing data from MoonLake’s MIRA and VELA trials, which evaluated the safety and efficacy of Sonelokimab, could be sufficient for a marketing application. Avoiding an additional Phase 3 trial represents a substantial saving in both time and capital, which is critical for a clinical-stage company with no current revenue.
"The feedback from the FDA is a pivotal moment for MoonLake and for patients suffering from HS," said Jorge Santos da Silva, PhD, CEO of MoonLake, in a statement. "We are encouraged by the productive discussion and now have a clear path forward for our BLA submission."
Market reaction was swift and decisive. The stock gapped up significantly at the market open, with trading volume well above its daily average. As of midday, the company's market capitalization stood at approximately $791 million. The stock has seen considerable volatility over the past year, with a 52-week range spanning from a low of $5.95 to a high of $62.75.
Sonelokimab is a Nanobody-based biologic designed to selectively target and inhibit the inflammatory cytokines IL-17A and IL-17F. This dual-action mechanism is believed to be a key differentiator in treating a range of inflammatory diseases. The positive feedback for HS follows a similar positive development for its psoriatic arthritis program.
While the path to submission is now clearer, MoonLake must still complete the necessary steps to prepare its BLA. The company will need to finalize its data package and meet all regulatory requirements for the filing. The FDA’s ultimate approval is not guaranteed, but the guidance marks the removal of a major potential hurdle.
Investor focus will now shift to the execution of this strategy and the eventual BLA submission in 2026. The next major catalyst will likely be the FDA's formal acceptance of the application for review, which would trigger a Prescription Drug User Fee Act (PDUFA) date for a final decision.