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Clene isasama ang mga pagsusuri ng ALS biomarker sa NDA para sa accelerated approval

Inilalantad ng 8-K na isasama ng Clene ang mga bagong pagsusuri ng biomarker sa paghahain ng NDA nito para sa CNM-Au8 sa ALS, na malinaw na sumusuporta sa accelerated-approval pathway. Walang PDUFA date, advisory-committee date, o topline readout na nakasaad; ang filing mismo ang milestone.

Mahahalagang fact

Na-file
Ago 10, 2026, 12:07 PM
Kaganapan
Naisumite ang aplikasyon
Direksyon
Neutral
Kumpanya
CLNNClene
Asset
CNM-Au8
Pinagmulan
SEC 8-K
Kumpiyansa
May source

Sipi mula sa source

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 Petsa ng Ulat (Petsa ng pinakamaagang naiulat na kaganapan): 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.

SEC 8-K

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Kapansin-pansin
Ene 12, 2026
01:30 PM
CLNNClene

Clene Inc. – Inilabas ang datos ng biomarker ng CNM-Au8 bago ang miting sa FDA

Iba paSEC 8-K