Biohaven Misses The Mark In Depression Trial, Stock Falls

Benzinga_recent_news2025-12-26

On Wednesday, Biohaven Ltd. (NYSE:BHVN) reported results from a Phase 2 proof-of-concept study evaluating BHV-7000 for major depressive disorder (MDD). The study did not meet its primary endpoint, a ...

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(NYSE:BHVN) reported results from a Phase 2 proof-of-concept study evaluating BHV-7000 for major depressive disorder (MDD).\nThe study did not meet its primary endpoint, a ...</p>\n\n<a href=\"https://www.benzinga.com/analyst-stock-ratings/analyst-color/25/12/49592343/biohaven-misses-the-mark-in-depression-trial-stock-falls\">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":"XENE","symbol_name":"Xenon制药","start_time":0,"source_url":"https://www.benzinga.com/analyst-stock-ratings/analyst-color/25/12/49592343/biohaven-misses-the-mark-in-depression-trial-stock-falls","article_id":"2594990292","we_media_id":null,"thumbnails":["https://cdn.benzinga.com/files/images/story/2025/12/26/Medical-Research.jpeg?optimize=medium&dpr=2&auto=webp&width=240"],"rights":{"source":"benzinga_recent_news","url":"https://www.benzinga.com/analyst-stock-ratings/analyst-color/25/12/49592343/biohaven-misses-the-mark-in-depression-trial-stock-falls","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2594990292","pubTimestamp":1766755200,"columns":[],"sourceInfo":{"source_id":"benzinga_recent_news","name":"Benzinga"},"weMediaInfo":null,"summary":"Biohaven's Phase 2 study with BHV-7000 in MDD did not meet its primary endpoint of reducing depressive symptoms in comparison to placebo.","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"XENE":"Xenon制药","LU1093756325.SGD":"FTIF - Franklin K2 Alt Strat Fd A (acc) SGD-H1","BHVN":"Biohaven Pharmaceutical Holding Co Ltd.","LU1093756168.USD":"FRANKLIN K2 ALTERNATIVE STRATEGIES \"A\" (USD) ACC","BK4139":"生物科技"},"translate_title":"Biohaven在抑郁症试验中未达标，股价下跌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"XENE":1,"BHVN":1},"content_text":"On Wednesday, Biohaven Ltd. (NYSE:BHVN) reported results from a Phase 2 proof-of-concept study evaluating BHV-7000 for major depressive disorder (MDD).\nThe study did not meet its primary endpoint, a reduction of depressive symptoms as measured by change in the Montgomery Åsberg Depression Rating Scale (MADRS) over six weeks compared with placebo.\nTrends favoring BHV-7000 were observed in some clinically relevant subgroups, including participants with more severe depression at screening and baseline, on primary and secondary outcome measures.\nAlso Read: Biohaven Advances Toward Potential First FDA-Approved Therapy For Spinocerebellar Ataxia, FDA Drops Advisory Meeting\nOverall, BHV-7000 was safe and well-tolerated, with adverse events mostly mild and moderate in intensity and largely resolved spontaneously.\nAdditional analyses are ongoing.\nThe company considers the depression subgroup analyses as hypothesis-generating but, based upon strategic prioritization of its portfolio, does not plan on additional psychiatric clinical trials to keep resources focused on key priority areas of immunology, obesity, and epilepsy in 2026.\nThe Phase 2 miss is a setback but not entirely unexpected. William Blair said it approached the readout cautiously, citing persistent challenges in MDD trials, including execution risk and rising placebo response.\nAnalyst Myles Minter noted that prior MDD data for ezogabine and Xenon Pharmaceuticals Inc.’s (NASDAQ:XENE) azetukalner (X-NOVA) showed modest effect sizes, leaving little margin for further dilution in pivotal trials of KV7.2/7.3 potentiators.\nInvestors also remain divided on whether the extended-release formulation of opakalim, which showed zero somnolence in Phase 1, achieves sufficient CNS exposure, or whether the shift from immediate release reduced central activity.\nWilliam Blair said the latest data do little to ease these concerns, as no efficacy signal emerged and adverse event rates were similar between BHV-7000 and placebo.\nWhile Biohaven did disclose signals favoring BHV-7000 treatment in a subgroup of severely depressed patients at baseline, analyst Minter cautions against overinterpretation of these data, given the low number of subjects in the analysis (n=14 and n=15 BHV-7000 and placebo participants, respectively).\nWilliam Blair looks to pivotal data for opakalim in focal onset epilepsy in the first half of 2026 as a key data point to determine if the extended-release formulation of opakalim is an active formulation.\nWilliam Blair reiterates Market Perform rating as the analyst waits to see either regulatory clarity for Vyglxia following the recent CRL or convincing placebo-controlled data from the prioritized late-stage assets to be more constructive on the name under a new R&D cost basis.\nBHVN Price Action: Biohaven shares were down 15.45% at $9.14 during premarket trading on Friday, according to Benzinga Pro data.\nRead Next:\nPhoto via Shutterstock","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-2","news_tag":"dataReport","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; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.36.2","shortVersion":"4.36.2","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/2594990292","isCrawlerRequest":true}