Ionis: NDA zilganersen menjalani Priority Review, PDUFA 22 September 2026

The 8-K states the NDA for zilganersen in Alexander disease is under FDA Priority Review with a PDUFA target action date of September 22, 2026. Ionis also entered a license agreement with Recordati for ex-U.S. development and commercialization. This sets the next regulatory decision point for the asset.

Fakta utama

Diajukan: 29 Jul 2026, 11.31
Peristiwa: Tanggal PDUFA ditetapkan
Arah: Netral
Perusahaan: IONSIonis
Aset: zilganersen
Sumber: SEC 8-K
Keyakinan: Bersumber
Kalender: Keputusan FDA (PDUFA) · 22 Sep 2026 · Positif

Kutipan sumber

EX-99.1 2 ef20078953_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Ionis reports second quarter 2026 financial results and highlights progress on key programs - TRYNGOLZA ® (olezarsen) demonstrating early sHTG launch momentum, underscoring multi-billion-dollar revenue potential in large patient population – - Completed enrollment in Phase 3 REVEAL trial in Angelman syndrome - - On track to achieve 2026 financial guidance - CARLSBAD, Calif., July 29, 2026 – Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) (the “Company”) today reported financial results and provided key updates for the second quarter ended June 30, 2026. “With the approval of TRYNGOLZA in late June, Ionis is bringing the first and only treatment to reduce triglycerides and acute pancreatitis to people living with severe hypertrigly

SEC 8-K