MoonLake: FDA đồng thuận về kế hoạch pre-BLA cho sonelokimab trong viêm tuyến mồ hôi mủ (HS)

The 8-K discloses that MoonLake completed its final pre-BLA meeting with the FDA and reached alignment on submission plans and label strategy for sonelokimab in hidradenitis suppurativa. This regulatory milestone clears the path for the company to proceed with its planned BLA filing for the asset.

Thông tin chính

Nộp lúc: 11:09 11 thg 5, 2026
Sự kiện: Khác
Chiều hướng: Tích cực
Công ty: MLTXMoonLake
Tài sản: sonelokimab
Nguồn: SEC 8-K
Độ tin cậy: Có nguồn

Trích đoạn nguồn

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