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MoonLake Immunotherapeutics Shares Rise on FDA Alignment to File Application Without New Trials

Provided by Dow Jones Jan 8, 2026, 3:11:00 PM

By Elias Schisgall

MoonLake Immunotherapeutics shares climbed after the company said a meeting with the Food and Drug Administration had paved the way to file a Biologic License Application for a hidradenitis suppurativa treatment without additional clinical trials.

Shares were up 32% to $14.88 Thursday morning. The stock is down 69% over the past year after shares nosedived in late September.

The company said Thursday that it received a green light from the FDA to file a BLA for sonelokimab in hidradenitis suppurativa during a Type B meeting, establishing substantial evidence of effectiveness using data from existing clinical trials.

MoonLake added that it continues to plan to submit the BLA in the second half of the year.

Write to Elias Schisgall at elias.schisgall@wsj.com

(END) Dow Jones Newswires

January 08, 2026 10:11 ET (15:11 GMT)

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