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MateryalNaitakda ang petsa ng PDUFA
Clene: Posibleng pagtanggap ng NDA at PDUFA date sa H2 2026 para sa CNM-Au8 sa ALS
Ayon sa liham, plano ng Clene na magsumite ng NDA para sa CNM-Au8 sa pamamagitan ng accelerated approval pathway sa Q2 2026. Ang pagtanggap ng FDA sa NDA at pagbibigay ng PDUFA date ay maaaring mangyari sa ikalawang kalahati ng 2026, na may potensyal na pag-apruba sa 2027.
Mahahalagang fact
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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