Biotech Stock MoonLake Surges 33% After Announcing Positive Outcome From Type B Meeting With U.S. FDA-To The Moon - Tiger Brokers Online Investing Community - To The Moon

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Biotech Stock MoonLake Surges 33% After Announcing Positive Outcome From Type B Meeting With U.S. FDA

Reuters01-08

MoonLake Immunotherapeutics climbed 33% in the premarket on Thursday after the company said that the FDA will not require additional clinical trials to support a marketing application for its lead candidate, sonelokimab (SLK).

Citing a Type B meeting with the regulator, the Swiss biotech noted that the FDA agreed that without additional trials, its existing VELA-1, VELA-2, and MIRA trials could support a Biologic License Application for SLK in hidradenitis suppurativa, an inflammatory skin condition.

Given the official records of the meeting, the company said it will continue with its plans to submit a BLA for sonelokimab in H2 2026 for HS, which indicates an unmet medical need with a market opportunity expected to reach $15B by 2035.

“The fact that we can prepare the BLA with the wealth of data across the VELA and MIRA trials provides us and the FDA with flexibility to determine the best label possible, so that SLK, if approved, can have the most positive impact for HS patients,” CEO Jorge Santos da Silva added.

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class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2026-01-08 21:41</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><head></head><body><p><a href=\"https://laohu8.com/S/MLTX\">MoonLake Immunotherapeutics</a> climbed 33% in the premarket on Thursday after the company said that the FDA will not require additional clinical trials to support a marketing application for its lead candidate, sonelokimab (SLK).</p><p class=\"t-img-caption\"><img src=\"https://community-static.tradeup.com/news/5d3a89ad5142fed169196db585ea6ff6\" tg-width=\"867\" tg-height=\"618\"/></p><p style=\"text-align: left;\">Citing a Type B meeting with the regulator, the Swiss biotech noted that the FDA agreed that without additional trials, its 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