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MoonLake Says FDA May Allow Skin Drug Filing Without New Trials, Stock Soars - MoonLake (NASDAQ:MLTX)

Summary by Benzinga
MoonLake says FDA may allow approval filing for its HS drug Sonelokimab without new trials after strong study results, keeping its 2026 submission plans on track.

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MoonLake Says FDA May Allow Skin Drug Filing Without New Trials, Stock Soars - MoonLake (NASDAQ:MLTX)

MoonLake says FDA may allow approval filing for its HS drug Sonelokimab without new trials after strong study results, keeping its 2026 submission plans on track.

·New York, United States
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dermatologytimes.comdermatologytimes.com

FDA Feedback Supports BLA Pathway for Sonelokimab in HS

MoonLake Immunotherapeutics shares promising updates on sonelokimab's efficacy for hidradenitis suppurativa.

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Benzinga broke the news in New York, United States on Thursday, January 8, 2026.
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