一次情報の記録
重要その他
ムーンレイク: FDAがHS(化膿性汗腺炎)向けソネロキマブの事前BLA計画に合意
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.
主要事実
- 提出
- 2026年5月11日 11:09
- イベント
- その他
- 方向
- ポジティブ
- アセット
- sonelokimab
- 出典
- SEC 8-K
- 信頼度
- 出典あり
出典の抜粋
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