Primärquellen-Eintrag
EntscheidungsrelevantTopline-Ergebnisse
Xenon: X-TOLE2 Phase 3 azetukalner erreicht primären Endpunkt bei FOS
X-TOLE2 Phase 3 trial met its primary endpoint with a -53.2% median percent change in monthly focal onset seizure frequency for the 25 mg dose versus -10.4% for placebo. The company now plans to submit an NDA to the FDA in Q3 2026.
Kernfakten
- Eingereicht
- 9. März 2026, 11:36
- Ereignis
- Topline-Ergebnisse
- Richtung
- Positiv
- Unternehmen
XENEXenon- Asset
- azetukalner
- Quelle
- SEC 8-K
- Belegstatus
- Belegt
- Placebo-adjustiert 25 mg
- -42,7%
- Medianer prozentualer Wechsel 15 mg
- -34,5%
- Medianer prozentualer Wechsel 25 mg
- -53,2%
- Medianer prozentualer Wechsel Placebo
- -10,4%
Auszug aus der Quelle
EX-99.1 2 d107087dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Xenon Announces Positive Topline Data from Phase 3 X-TOLE2 Study of Azetukalner in Focal Onset Seizures (FOS) • X-TOLE2 met primary endpoint in both dose groups, including -53.2% median percent change (MPC) from baseline in monthly FOS frequency with 25 mg dose compared with -10.4% for placebo (p=0.000000000006) • X-TOLE2 outperformed Phase 2b X-TOLE study, with a placebo-adjusted MPC of -42.7% in 25 mg group in X-TOLE2 compared to -34.6% in 25 mg group in X-TOLE • Azetukalner was generally well-tolerated with a safety profile consistent with X-TOLE study • Xenon anticipates submitting New Drug Application for azetukalner in FOS to the U.S. FDA in Q3 2026 • X-TOLE2 data to be featured in Late Breaking Science oral presen