原始出處紀錄
重大申請已送件
Clene 於 FDA Type C 會議後計劃加速批准 ALS NDA
在收到 FDA Type C 會議最終紀錄後，Clene 確認其提出的 NfL 生物標記數據可能支持根據 Subpart H 加速批准提交 NDA。該公司現計劃於 2026 年第三季提交 NDA，數據來源包括 Phase 2 HEALEY、RESCUE-ALS 及 EAP。確認性 Phase 3 試驗計劃於 2027 年第一季啟動。
關鍵事實
來源摘錄
clnn20260503_8k.htm false 0001822791 0001822791 2026-05-04 2026-05-04 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 4, 2026 CLENE INC. (Exact name of registrant as specified in its charter) Delaware 001-39834 85-2828339 (State or other jurisdiction (Commission File Number) (IRS Employer of incorporation) Identification No.) 6550 South Millrock Drive , Suite G50 Salt Lake City , Utah 84121 (Address of principal executive offices) (Zip Code) ( 801 ) 676-9695 (Registrant’s telephone number, including area code) N/A (Former name or former address, if changed since last report.) Check the app