Nektar Alopecia Trial Misses Endpoint, Hits Significance After Patient Exclusion

Benzinga_recent_news12-17

Nektar Therapeutics (NASDAQ:NKTR) on Tuesday revealed topline results from the 36-week induction treatment period of the Phase 2b REZOLVE-AA trial of investigational rezpegaldesleukin. The global ...

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class=\"title\">\nNektar Alopecia Trial Misses Endpoint, Hits Significance After Patient Exclusion\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-12-17 00:30 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.benzinga.com/markets/biotech/25/12/49426419/nektar-alopecia-trial-misses-endpoint-hits-significance-after-patient-exclusion><strong>Benzinga_recent_news</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Nektar Therapeutics (NASDAQ:NKTR) on Tuesday revealed topline results from the 36-week induction treatment period of the Phase 2b REZOLVE-AA trial of investigational rezpegaldesleukin.\nThe global ...</p>\n\n<a href=\"https://www.benzinga.com/markets/biotech/25/12/49426419/nektar-alopecia-trial-misses-endpoint-hits-significance-after-patient-exclusion\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BSA","symbol_name":"OM Asset Management plc","start_time":0,"source_url":"https://www.benzinga.com/markets/biotech/25/12/49426419/nektar-alopecia-trial-misses-endpoint-hits-significance-after-patient-exclusion","article_id":"2592399309","we_media_id":null,"thumbnails":["https://cdn.benzinga.com/files/images/story/2025/12/16/Nov-2--2019-San-Francisco-----Ca-----Usa.jpeg?optimize=medium&dpr=2&auto=webp&width=240"],"rights":{"source":"benzinga_recent_news","url":"https://www.benzinga.com/markets/biotech/25/12/49426419/nektar-alopecia-trial-misses-endpoint-hits-significance-after-patient-exclusion","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2592399309","pubTimestamp":1765902600,"columns":[],"sourceInfo":{"source_id":"benzinga_recent_news","name":"Benzinga"},"weMediaInfo":null,"summary":"Nektar Therapeutics reported Phase 2b alopecia areata data showing hair regrowth trends, narrowly missing significance before eligibility adjustments.","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BSA":"OM Asset Management plc","EASI":"Amplify EASI Tactical Growth ETF","BK4007":"制药","NKTR":"内克塔治疗"},"translate_title":"Nektar脱发试验未达到终点，排除患者后达到显著性","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"BSA":1,"EASI":1,"NKTR":1},"content_text":"Nektar Therapeutics (NASDAQ:NKTR) on Tuesday revealed topline results from the 36-week induction treatment period of the Phase 2b REZOLVE-AA trial of investigational rezpegaldesleukin.\nThe global Phase 2b study is being conducted in 92 patients with severe-to-very-severe alopecia areata.\nAlopecia areata is an autoimmune condition where the immune system attacks hair follicles, causing sudden, patchy hair loss, usually in coin-sized spots, but it can progress to total scalp (alopecia totalis) or body (alopecia universalis) hair loss.\nAlso Read: AbbVie’s Patch Baldness Study Finds High Hair Coverage Rates With Investigational Drug Upadacitinib\nThe primary endpoint was the mean percentage reduction from baseline in the Severity of Alopecia Tool (SALT) score at Week 36.\nPrimary and secondary endpoints were assessed at the end of the 36-week induction treatment period.\nBoth rezpegaldesleukin dose arms more than doubled the SALT score reduction treatment effect observed with placebo, with the majority of patients experiencing hair growth at Week 16 or later. \nThe primary endpoint narrowly missed statistical significance with the mean percent SALT reduction at Week 36 of 28.2% for the 24 µg/kg rezpegaldesleukin arm, 30.3% for the 18 µg/kg rezpegaldesleukin arm, and 11.2% for placebo (p=0.186 and p=0.121, respectively).\nAt all timepoints, the rezpegaldesleukin treatment arms separated from placebo in the study.\nFour of 92 patients included in the modified intent-to-treat (mITT) analysis were found to have major study eligibility violations that should have disqualified them for randomization into the trial.\nBoth rezpegaldesleukin treatment arms met statistical significance on the primary endpoint when excluding the four patients with major study eligibility violations.\nAt Week 36, the mean percent SALT reduction was 29.6% for 24 µg/kg, 30.4% for 18 µg/kg, and 5.7% for placebo (p=0.049 and p=0.042, respectively).\nThe absolute treatment effect for the rezpegaldesleukin arms was similar with or without the exclusion of eligibility violations.\nOne patient in the placebo arm with an eligibility violation accounted for the 5.5% difference in the performance of the placebo arm.\nBoth rezpegaldesleukin treatment arms showed a dose-dependent clinical treatment effect as compared to placebo on the key secondary endpoints of SALT ≤30, SALT≤20, and SALT≤10 and SALT30.\nFollowing 36 weeks, patients who demonstrated hair growth but had not yet reached SALT>20 had the option to continue for an additional 16 weeks of treatment through Week 52 in a blinded extension period.\nNektar plans to submit the REZOLVE-AA results for presentation at a medical conference in 2026.\nData from the patients ongoing in the 16-week treatment extension will be available in the early second quarter of 2026.\nIn September, Nektar Therapeutics shared new data from its ongoing REZOLVE-AD Phase 2b study of rezpegaldesleukin.\nThe study showed that rezpegaldesleukin met the primary endpoint, with statistically significant improvement in the Eczema Area and Severity Index (EASI) at week 16 compared with placebo.\nKey secondary endpoints—including EASI-75, EASI-90, Itch Numerical Rating Scale (NRS), vIGA-AD, and Body Surface Area (BSA)—also demonstrated significant disease reduction in patients with moderate to severe atopic dermatitis.\nNKTR Price Action: Nektar Therapeutics shares were down 7.86% at $49.11 at the time of publication on Tuesday, according to Benzinga Pro data.\nRead Next:\nPhoto by Sundry Photography via Shutterstock","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; 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