प्राथमिक स्रोत रिकॉर्ड
निर्णायकटॉपलाइन परिणाम
Alkermes: LUMRYZ ने फेज 3 IH अध्ययन में सभी एंडपॉइंट पूरे किए
REVITALYZ Phase 3 trial showed statistically significant improvements in ESS, PGI-C and IHSS versus placebo. Alkermes plans to file an sNDA for idiopathic hypersomnia by end of 2026. Marketing of LUMRYZ for IH is restricted until March 1, 2028 per prior settlement.
मुख्य तथ्य
- फाइल किया गया
- 12 मई 2026, 11:07 am
- घटना
- टॉपलाइन परिणाम
- दिशा
- सकारात्मक
- कंपनी
ALKSAlkermes- संपत्ति
- sodium oxybate
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
- पी मान ईएसएस
- p<0.0001
- पी मान आईएचएसएस
- p<0.0001
- प्रतिभागी
- 104
- पी मान पीजीआई सी
- p<0.0001
स्रोत का अंश
EX-99.1 2 alks-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Alkermes Contacts: For Investors: Sandy Coombs +1 781 609 6377 For Media: Gretchen Murphy +1 781 609 6419 Alkermes Announces Positive Topline Results From REVITALYZ SM Phase 3 Study Evaluating LUMRYZ ® (sodium oxybate) Extended-Release in Adults With Idiopathic Hypersomnia – LUMRYZ Met All Primary and Key Secondary Endpoints Demonstrating Statistically Significant and Clinically Meaningful Improvements Compared to Placebo in Excessive Daytime Sleepiness and Patient-Reported Disease Severity – – Safety Profile Consistent With Known Safety Profile of LUMRYZ – DUBLIN, May 12, 2026—Alkermes plc (Nasdaq: ALKS) today announced positive topline results from the REVITALYZ SM double-blind, placebo-controlled, randomized withdrawal, mult