Clene计划在FDA C型会议后加速批准ALS NDA

在收到FDA C型会议最终纪要后，Clene确认其提出的NfL生物标志物数据可能支持根据Subpart H加速批准提交NDA。该公司现计划于2026年第三季度提交NDA，数据支持来自HEALEY、RESCUE-ALS和EAP的II期研究。III期确证性试验计划于2027年第一季度启动。

关键事实

申报时间: 2026年5月4日 12:02
事件: 申请已提交
方向: 积极
公司: CLNNClene
资产: CNM-Au8
来源: SEC 8-K
可信度: 有来源

来源摘录

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

SEC 8-K