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Decision-gradeNaitakda ang petsa ng PDUFA
Ionis: olezarsen sNDA tinanggap para sa Priority Review, PDUFA Hunyo 30, 2026
Tinanggap ng FDA ang sNDA para sa olezarsen sa sHTG sa ilalim ng Priority Review na may target na PDUFA action date na Hunyo 30, 2026. Itinaas ng kumpanya ang peak net sales guidance nito para sa olezarsen sa sHTG sa >$3B. Ang mga paghahanda para sa paglulunsad ay nananatiling nasa tamang landas para sa posibleng pag-apruba sa 2026.
Mahahalagang fact
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EX-99.1 2 ef20071749_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Ionis reports first quarter 2026 financial results and highlights progress on key programs - TRYNGOLZA ® (olezarsen) showed increasing demand in FCS driven by strong launch execution – - Olezarsen sNDA accepted by the FDA for Priority Review; sHTG launch preparations on track – – Increasing annual TRYNGOLZA peak net sales guidance to >$3B for sHTG – - Zilganersen NDA for Alexander disease accepted for Priority Review, paving way for Ionis’ first independent launch from leading neurology pipeline – - Strong first-quarter performance and outlook for the year supports improved 2026 financial guidance - CARLSBAD, Calif., April 29, 2026 – Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) (the “Company”) today reported financial results