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MoonLake: sumang-ayon ang FDA sa pre-BLA plans para sa sonelokimab sa HS

Ang 8-K ay nagpapahayag na nakumpleto ng MoonLake ang huling pre-BLA meeting nito sa FDA at nakamit ang pagkakahanay sa mga plano sa pagsusumite at diskarte sa label para sa sonelokimab sa hidradenitis suppurativa. Ang regulatory milestone na ito ay nagbubukas ng daan para sa kumpanya na magpatuloy sa nakaplanong BLA filing para sa asset.

Mahahalagang fact

Na-file
May 11, 2026, 11:09 AM
Kaganapan
Iba pa
Direksyon
Positibo
Kumpanya
MLTXMoonLake
Asset
sonelokimab
Pinagmulan
SEC 8-K
Kumpiyansa
May source

Sipi mula sa source

mnlk-20260510 0001821586 FALSE 0001821586 2025-11-05 2025-11-05 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ___________________ FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 or 15(d) of the SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): May 10, 2026 MOONLAKE IMMUNOTHERAPEUTICS (Exact Name of Registrant as Specified in Its Charter) Cayman Islands 001-39630 98-1711963 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.) Dorfstrasse 29 6300 Zug Switzerland (Address of Principal Executive Offices and Zip Code) 41 415108022 (Registrant’s Telephone Number, Including Area Code) N/A (Former Name or Former Address, if Changed Since Last Report) Check the appropriate box below i

SEC 8-K

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