Plano ng Clene ang NDA para sa ALS na may pinabilis na pag-apruba pagkatapos ng pulong ng FDA Type C

Matapos matanggap ang huling mga minuto ng pulong ng FDA Type C, kinumpirma ng Clene na ang iminungkahing data ng biomarker ng NfL ay maaaring suportahan ang isang NDA sa ilalim ng Subpart H na pinabilis na pag-apruba. Layunin na ngayon ng kumpanya na isumite ang NDA sa Q3 2026, na sinusuportahan ng data mula sa Phase 2 HEALEY, RESCUE-ALS, at EAP. Isang Phase 3 confirmatory trial ang planong simulan sa Q1 2027.

Mahahalagang fact

Na-file: May 4, 2026, 12:02 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Positibo
Kumpanya: CLNNClene
Asset: CNM-Au8
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

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