Syndax Pharmaceuticals Stock Falls After Data From Mid-Stage Study Of Revumenib In Form Of Blood Cancer

Benzinga2024-11-13

On Tuesday, Syndax Pharmaceuticals Inc (NASDAQ:SNDX) revealed topline results from the relapsed or refractory (R/R) mutant NPM1 (mNPM1) acute myeloid leukemia (AML) cohort in the pivotal Phase 2 ...

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Among the patients who achieved CR/CRh, 12 had a CR, and three had a CRh.At the data cutoff, the observed median duration of CR/CRh responses was 4.7 months, with three patients remaining in response.Minimal residual disease  status was assessed in 14 of 15 patients who achieved CR/CRh, 64%  of whom were MRD negative. The overall response rate was 47%.17% of patients who achieved an overall response underwent hematopoietic stem cell transplant  following treatment with revumenib, with three resumin","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"SSI":"Stage Stores Inc","SNDX":"Syndax Pharmaceuticals, Inc. ","BK4139":"生物科技","HSCT":"HOOPS SCOUTING USA","CR":"crane","BK4161":"工业机械"},"translate_title":"Revumenib治疗血癌中期研究数据公布后，Syndax Pharmaceuticals股价下跌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CR":1,"HSCT":1,"SNDX":1,"SSI":1},"content_text":"On Tuesday, Syndax Pharmaceuticals Inc (NASDAQ:SNDX) revealed topline results from the relapsed or refractory (R/R) mutant NPM1 (mNPM1) acute myeloid leukemia (AML) cohort in the pivotal Phase 2 portion of the AUGMENT-101 trial of revumenib.\nThe cohort met the primary endpoint with a complete remission (CR) plus CR with a partial hematological recovery (CRh) rate of 23% among the efficacy evaluable adults.\nAlso Read: FDA Approves Incyte/Syndax Partnered Drug For Chronic Graft-Versus-Host Disease, A Post-Transplant Complication\nAmong the patients who achieved CR/CRh, 12 had a CR, and three had a CRh.\nAt the data cutoff, the observed median duration of CR/CRh responses was 4.7 months, with three patients remaining in response.\nMinimal residual disease (MRD) status was assessed in 14 of 15 patients who achieved CR/CRh, 64% (9/14) of whom were MRD negative. The overall response rate (ORR) was 47%.\n17% of patients who achieved an overall response underwent hematopoietic stem cell transplant (HSCT) following treatment with revumenib, with three resuming revumenib therapy post-transplant.\nThe safety population included 84 adult and pediatric patients with R/R mNPM1 AML in the Phase 2 portion of the AUGMENT-101 trial.\nThe safety profile observed with revumenib in this population was consistent with previously reported data.\nTreatment-related adverse events (TRAEs) leading to treatment discontinuations were 5%\nThe company is conducting several trials of revumenib across the treatment landscape in mNPM1 and KMT2A-rearranged (KMT2Ar) acute leukemias.\nSyndax expects to achieve the following upcoming revumenib milestones:\n\nReceive FDA approval for R/R KMT2Ar acute leukemias in the fourth quarter of 2024.\nInitiate a pivotal combination trial with venetoclax/azacitidine in newly diagnosed mNPM1 AML or KMT2Ar acute leukemias by year-end 2024.\nPublish pivotal AUGMENT-101 results in R/R mNPM1 AML patients and present results at a medical conference in the first half of 2025.\nSubmit a supplemental NDA for R/R mNPM1 AML in the first half of 2025.\n\nPrice Action: SNDX stock is down 22.1% at $16.96 at last check Tuesday.\nRead Next:\n\nHome Depot’s Earnings Beat Sets Conservative Tone for FY24, J.P. Morgan Predicts Slowing Deterioration Ahead\n\nUp Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market.\nGet the latest stock analysis from Benzinga?\n\nThis article Syndax Pharmaceuticals Stock Falls After Data From Mid-Stage Study Of Revumenib In Form Of Blood Cancer originally appeared on Benzinga.com\n© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.","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":"dataReport","news_rank":0,"symbols":[],"gpt_button":1},"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; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.30.2","shortVersion":"4.30.2","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2483536610"}