MoonLake Immunotherapeutics (MLTX) shares jumped 31.80% to $14.88, up $3.59, after the company reported a positive outcome from a Type B meeting with the U.S. Food and Drug Administration regarding its lead candidate sonelokimab for hidradenitis suppurativa.
The rally followed news that the FDA indicated substantial evidence of effectiveness for sonelokimab could potentially be established without the need for additional clinical trials, allowing MoonLake to rely on data from its VELA-1, VELA-2, and MIRA studies in a future biologics license application.
On the day of the announcement, MLTX opened near $11.40, reached an intraday high of approximately $15.20, and touched a low around $11.20, compared with a previous close of $11.29.
Trading volume was significantly above the stock's average daily volume, highlighting strong investor interest following the regulatory update.
MoonLake's 52-week range is approximately $9.72 - $55.85, reflecting sharp swings tied to clinical and regulatory milestones.
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