1차 출처 기록
중대신청 제출
Clene, ALS 바이오마커 분석을 가속승인 NDA에 포함하기로
8-K 공시에서 Clene이 ALS 대상 CNM-Au8 NDA 제출에 새로운 바이오마커 분석을 포함할 것이라고 밝혔으며, 가속승인 경로를 명시적으로 뒷받침합니다. PDUFA 날짜, 자문위원회 날짜 또는 주요 결과 발표는 명시되지 않았으며, 제출 자체가 이정표입니다.
핵심 사실
출처 발췌
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