原始来源记录
重大申请已提交
Clene 将在 ALS 加速批准 NDA 中纳入生物标志物分析
该 8-K 文件披露，Clene 将把新的生物标志物分析纳入其针对 ALS 的 CNM-Au8 NDA 提交，明确支持加速批准途径。未提及 PDUFA 日期、顾问委员会日期或主要读数；该备案本身即为里程碑。
关键事实
来源摘录
clnn20260806_8k.htm false 0001822791 0001822791 2026-08-10 2026-08-10 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): August 10, 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