一次情報の記録
重要PDUFA 日設定
Clene: NDA受理およびPDUFA日付が2026年H2にCNM-Au8のALSで可能
同レターは、Cleneが2026年Q2に加速承認経路を通じてCNM-Au8のNDAを提出する計画であると述べています。NDAのFDA受理およびPDUFA日付の発行は2026年後半に起こる可能性があり、2027年に承認の可能性があります。
主要事実
出典の抜粋
EX-99.1 2 ex_924033.htm EXHIBIT 99.1 ex_924033.htm Exhibit 99.1 CLENE ISSUES STOCKHOLDER LETTER HIGHLIGHTING UPCOMING CNM-AU8 ® 2026 CATALYSTS ● Operating capital runway sufficient into the fourth quarter of 2026 ● In-person Type C FDA meeting scheduled by end of the first quarter of 2026 to discuss the latest CNM-Au8 data submitted in late 2025 ● Anticipated submission of a New Drug Application (NDA) to FDA for CNM-Au8 via an accelerated regulatory pathway in the second quarter of 2026 ● Potential for FDA acceptance of this NDA and issuance of a Prescription Drug User Fee Act (PDUFA) date in the second half of 2026 SALT LAKE CITY, Feb. 24, 2026 -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene” or the “Company”) and its wholly owned subsidiary Clene Nanomedicine