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MaterialSolicitud presentada
Clene planea la presentación de la NDA en el tercer trimestre de 2026 para CNM-Au8 en ELA
Tras una exitosa reunión de Tipo C con la FDA, Clene confirmó que sus datos de biomarcador NfL pueden respaldar una NDA bajo la vía de aprobación acelerada para ELA. La compañía ahora tiene la intención de presentar la NDA en el tercer trimestre de 2026 e iniciará un ensayo confirmatorio de Fase 3 (RESTORE-ALS) en el primer trimestre de 2027.
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Extracto de la fuente
EX-99.1 2 ex_908797.htm EXHIBIT 99.1 ex_908797.htm Exhibit 99.1 CLENE REPORTS First QUARTER 2026 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS ● After successful completion of FDA Type C meeting, Clene expects to submit an NDA for CNM-Au8® under the accelerated approval pathway in the third quarter of 2026 ● In January 2026, Clene completed an oversubscribed registered direct offering totaling over $28 million, including an initial tranche of more than $6 million and two additional tranches totaling over $22 million tied to regulatory milestones ● In May 2026, Clene amended its existing $10 million convertible debt facility, extending maturity by six months to August 2027 and eliminating required monthly principal and interest payments before maturity ● In May 2026, Clene com