原始来源记录
重大其他
MoonLake：FDA就sonelokimab在HS中的pre-BLA计划达成一致
该8-K披露，MoonLake已完成与FDA的最终pre-BLA会议，并在sonelokimab用于化脓性汗腺炎的申报计划和标签策略上达成一致。这一监管里程碑为公司推进该资产的BLA申报扫清了道路。
关键事实
- 申报时间
- 2026年5月11日 11:09
- 事件
- 其他
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
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