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중대신청 제출
Clene, FDA Type C 미팅 후 ALS 가속승인 NDA 계획
최종 FDA Type C 미팅 회의록을 받은 후, Clene은 제안한 NfL 바이오마커 데이터가 Subpart H 가속승인에 따른 NDA를 뒷받침할 수 있음을 확인했습니다. 회사는 현재 2026년 3분기에 NDA를 제출할 계획이며, Phase 2 HEALEY, RESCUE-ALS 및 EAP 데이터로 뒷받침됩니다. 확증적 Phase 3 시험은 2027년 1분기에 시작될 예정입니다.
핵심 사실
출처 발췌
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