प्राथमिक स्रोत रिकॉर्ड
निर्णायकटॉपलाइन परिणाम
Xenon: फेज 3 X-TOLE2 अध्ययन में azetukalner ने FOS में प्राइमरी एंडपॉइंट हासिल किया
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.
मुख्य तथ्य
- फाइल किया गया
- 9 मार्च 2026, 11:36 am
- घटना
- टॉपलाइन परिणाम
- दिशा
- सकारात्मक
- कंपनी
XENEXenon- संपत्ति
- azetukalner
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
- प्लेसिबो समायोजित 25एमजी
- -42.7%
- औसत प्रतिशत परिवर्तन 15एमजी
- -34.5%
- औसत प्रतिशत परिवर्तन 25एमजी
- -53.2%
- औसत प्रतिशत परिवर्तन प्लेसिबो
- -10.4%
स्रोत का अंश
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