Record mula sa primary source
MateryalNaitakda ang petsa ng PDUFA
Plano ng Clene na magsumite ng NDA para sa CNM-Au8 sa ALS sa Q1 2026
Plano na ngayon ng Clene na magsumite ng NDA para sa CNM-Au8 sa ALS sa ilalim ng accelerated approval pathway sa unang quarter ng 2026, kasunod ng pagkumpleto ng karagdagang biomarker analyses at isang planned Type C meeting sa FDA. Pinayuhan ng FDA ang kumpanya na humiling ng meeting na ito upang suriin ang biomarker data analyses, na inaasahang makukumpleto sa madaling panahon.
Mahahalagang fact
Sipi mula sa source
EX-99.1 2 ex_855915.htm EXHIBIT 99.1 ex_855915.htm Exhibit 99.1 CLENE REPORTS Third QUARTER 2025 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS ● As the U.S. Food and Drug Administration (FDA) proposed, Clene is concluding analyses of its ALS biomarker data with completion planned shortly ● The FDA advised Clene to request a Type C meeting to review these further ALS biomarker data analyses ● The Company plans to submit a New Drug Application (NDA) in the first quarter of 2026 under an accelerated approval pathway ● The Company expects to have the first patient dosed in the confirmatory Phase 3 RESTORE-ALS trial of CNM-Au8 in the first half of 2026 ● The FDA and Clene participated in a Type B end of Phase 2 meeting in the third quarter of 2025 to discuss the Company’s MS clini