Primärquellen-Eintrag
EntscheidungsrelevantTopline-Ergebnisse
Ionis: Phase-3-Topline-Daten von Bepirovirsen aus B-Well 1 und 2 bei chronischer Hepatitis B (CHB) positiv
Positive topline results from the pivotal Phase 3 B-Well 1 and B-Well 2 studies of bepirovirsen in chronic hepatitis B were announced. The data showed a statistically significant and clinically meaningful functional cure rate, triggering planned worldwide regulatory submissions in 2026.
Kernfakten
- Eingereicht
- 12. Jan. 2026, 12:00
- Ereignis
- Topline-Ergebnisse
- Richtung
- Positiv
- Unternehmen
IONSIonis- Asset
- bepirovirsen
- Quelle
- SEC 8-K
- Belegstatus
- Belegt
Auszug aus der Quelle
EX-99.1 2 ef20062670_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Ionis well-positioned for continued momentum and substantial value creation in 2026 with two new independent launches and several pivotal data readouts - TRYNGOLZA ® (olezarsen) outperforms expectations, achieved 2025 preliminary U.S. net product sales of $105M* as first FDA-approved treatment for FCS; sNDA for sHTG submitted for review – - Increasing annual TRYNGOLZA peak net sales guidance to >$2B for sHTG – - Positive topline results announced for pivotal Phase 3 program of bepirovirsen in chronic hepatitis B; first of five Phase 3 readouts from partnered programs expected this year – CARLSBAD, Calif., January 12 – Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced highlights from the Company's 2025 achievements and
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Wesentlich
28. Apr. 2026
06:06
IONSIonis