Sage (SAGE) Down 20% on Parkinson's Study Missing Primary Goal

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Shares of Sage Pharmaceuticals SAGE dropped 19.6% on Wednesday after management shared topline results from the phase II PRECEDENT study (n=86) evaluating its lead neuropsychiatric candidate ...

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Per management, the analyses of data also did not indicate any meaningful differences versus placebo in the other exploratory endpoints, such as SCOPA-Cog.Management also pointed out that 48 patients, which represent more than half of the total study participants, experienced treatment emergent adverse events  ranging from mild to moderate in severity.Year to date, shares of Sage have lost 42.0% compared with the industry’s 11.2% fall.Following the above setbacks and to support Zurzuvae’s commercial launch, Sa","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU0820561818.USD":"安联收益及增长平衡基金Cl AM DIS","BK4083":"家庭装潢零售","BK4561":"索罗斯持仓","IE00BKVL7J92.USD":"Legg Mason ClearBridge - US Equity Sustainability Leaders A Acc USD","SG9999001440.SGD":"United Global Dividend Equity Fund A SGD Dist","HD":"家得宝","BK4581":"高盛持仓","LU1496350171.SGD":"FRANKLIN DIVERSIFIED BALANCED \"A\" (SGDHDG) ACC","BK4504":"桥水持仓","LU1496350502.SGD":"FRANKLIN DIVERSIFIED DYNAMIC \"A\" (SGDHDG) ACC","LU1093756168.USD":"FRANKLIN K2 ALTERNATIVE STRATEGIES \"A\" (USD) ACC","LU2756315318.SGD":"ALLIANZ INCOME AND GROWTH \"AMG\" (SGDHDG) INC A","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","LU0943347566.SGD":"安联收益及增长平衡基金AM H2-SGD","ANIP":"ANI Pharmaceuticals, Inc.","IE00B894F039.SGD":"Legg Mason ClearBridge - US Aggressive Growth A Acc SGD-H","LU0234570918.USD":"高盛全球核心股票组合Acc Close","MCI":"Babson Capital Corporate Investors","BK4530":"医药外包概念","SAGE":"Sage Therapeutics","ADMA":"ADMA Biologics Inc","PPD":"PPD, Inc.","BK4023":"应用软件","LU1551013342.USD":"Allianz Income and Growth Cl AMg2 DIS USD","LU0079474960.USD":"联博美国增长基金A","LU1093756325.SGD":"FTIF - Franklin K2 Alt Strat Fd A (acc) SGD-H1","LU0390134368.USD":"FRANKLIN GLOBAL GROWTH \"A\" (USD) ACC","BK4567":"ESG概念","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","PD":"PagerDuty, Inc.","BK4585":"ETF&股票定投概念","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","LU0820561909.HKD":"ALLIANZ INCOME AND GROWTH \"AM\" (HKD) INC","LU1169590202.USD":"ALLSPRING (LUX)  U.S. SELECT EQUITY \"I\" (USD) ACC","LU0820562030.AUD":"ALLIANZ INCOME AND GROWTH \"AMH2\" (AUDHDG) H2 INC","BK4139":"生物科技","ABVC":"ABVC BioPharma, Inc.","BK4566":"资本集团","BK4007":"制药","LU2756315664.SGD":"ALLIANZ INCOME AND GROWTH \"AMI\" (SGDHDG) INC","IE00BZ1G4Q59.USD":"LEGG MASON CLEARBRIDGE US EQUITY SUSTAINABILITY LEADER \"A\"(USD) INC (A)","IE00B19Z9Z06.USD":"Legg Mason ClearBridge - US Aggressive Growth A Acc USD","IE00BWXC8680.SGD":"PINEBRIDGE US LARGE CAP RESEARCH ENHANCED \"A5\" (SGD) ACC","BK4121":"生命科学工具和服务","LU0689472784.USD":"安联收益及增长基金Cl AM AT Acc","CRL":"查尔斯河","BK4588":"碎股","BK4550":"红杉资本持仓","BIIB":"渤健公司"},"translate_title":"鼠尾草（SAGE）在帕金森研究中下降了20%，没有达到主要目标","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CRL":1,"ANIP":1,"BIIB":1,"HD":1,"SAGE":1,"PPD":1,"PD":1,"MCI":1,"ADMA":0.9,"ABVC":0.62},"content_text":"Shares of Sage Pharmaceuticals SAGE dropped 19.6% on Wednesday after management shared topline results from the phase II PRECEDENT study (n=86) evaluating its lead neuropsychiatric candidate dalzanemdor in patients with mild cognitive impairment (MCI) associated with Parkinson’s disease (PD).\nThe study failed to achieve its primary endpoint of demonstrating a statistically significant difference from baseline in participants treated with orally-administered dalzanemdor, when compared to placebo. Per management, the analyses of data also did not indicate any meaningful differences versus placebo in the other exploratory endpoints, such as SCOPA-Cog.\nManagement also pointed out that 48 patients, which represent more than half of the total study participants, experienced treatment emergent adverse events (TEAEs) ranging from mild to moderate in severity.\nBased on these results, management has decided not to pursue the development of dalzanemdor in PD indication. The share price was down likely due to this reason.\nYear to date, shares of Sage have lost 42.0% compared with the industry’s 11.2% fall.\nImage Source: Zacks Investment Research\nApart from PD, Sage Therapeutics is evaluating dalzanemdor as a potential treatment for patients with cognition dysfunction caused by Huntington’s disease (HD) across three ongoing clinical studies — two phase II studies (DIMENSION and SURVEYOR) and a phase III study (PURVIEW). The candidate is also being evaluated in a mid-stage study for treating cognitive issues associated with Alzheimer’s disease. Data from these studies are expected throughout this year.\nSAGE has been under pressure since last year when the FDA decided on zuranolone in postpartum depression (PPD) and major depressive disorder (MDD) indications. While the agency approved the drug for treating PPD, it issued a complete response letter (CRL) in the MDD indication. The drug will be marketed in PPD indication under the trade name Zurzuvae.\nPer the CRL, the FDA stated that the NDA filing did not provide substantial evidence of effectiveness to support the approval of zuranolone. Hence, an additional study or studies will be needed.\nThough the approval in PPD was positive, MDD is a much larger and more lucrative market opportunity. In addition, the FDA approval for PPD also comes with a back box warning – advising patients not to drive or operate heavy machinery for at least 12 hours after taking Zurzuvae.\nSage Therapeutics has developed Zurzuvae in collaboration with Biogen BIIB. Currently, Sage and Biogen are evaluating the further course of action. Management is yet to notify a future course of action in this regard.\nFollowing the above setbacks and to support Zurzuvae’s commercial launch, Sage Therapeutics implemented a strategic reorganization plan. Based on this plan, the company reduced its workforce by around 40%, focused on the pipeline development of dalzanemdor and lead neurology program, SAGE-324. Like Zurzuvae, SAGE-324 is also being developed in collaboration with Biogen.\n\nSage Therapeutics, Inc. Price\n\nSage Therapeutics, Inc. price | Sage Therapeutics, Inc. Quote\n\nZacks Rank & Key Picks\nSage currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include ADMA Biologics ADMA and ANI Pharmaceuticals ANIP, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.\nIn the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. During the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have surged 33.6%.\nEarnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.\nIn the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have risen from $4.12 to $4.43. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.04. Year to date, shares of ANIP have risen 18.8%.\nEarnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.\nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nBiogen Inc. (BIIB) : Free Stock Analysis Report\nANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report\nADMA Biologics Inc (ADMA) : Free Stock Analysis Report\nSage Therapeutics, Inc. (SAGE) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":null,"is_publish_news":null,"is_publish_highlight":null,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"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":"4.22.4","shortVersion":"4.22.4","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/2428510238"}