一次情報の記録
決定級PDUFA 日設定
Ionis: olezarsen sNDAが優先審査で受理、PDUFAは2026年6月30日
FDAがsHTGを対象としたolezarsenのsNDAを優先審査で受理し、PDUFA目標アクション日は2026年6月30日。同社はsHTGにおけるolezarsenのピーク純売上高ガイダンスを30億ドル超に引き上げた。2026年の承認に向けた発売準備は順調に進んでいる。
主要事実
出典の抜粋
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