Aerovate (AVTE) Down as Lead Drug Fails to Meet PAH Study Goals

Zacks06-18

Aerovate Therapeutics’ AVTE shares plummeted 93.3% in the last trading session on Jun 17 after the company announced disappointing top-line results from the mid-stage portion of the IIb/III IMPAHCT ...

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overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nAerovate (AVTE) Down as Lead Drug Fails to Meet PAH Study Goals\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-06-18 21:21 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/aerovate-avte-down-lead-drug-132100615.html><strong>Zacks</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Aerovate Therapeutics’ AVTE shares plummeted 93.3% in the last trading session on Jun 17 after the company announced disappointing top-line results from the mid-stage portion of the IIb/III IMPAHCT ...</p>\n\n<a href=\"https://finance.yahoo.com/news/aerovate-avte-down-lead-drug-132100615.html\">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":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://finance.yahoo.com/news/aerovate-avte-down-lead-drug-132100615.html","article_id":"2444432231","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/stId3gHSUQwaleeZdH.dgQ--~B/aD00MTM7dz02MjA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/6707b6de8d8e03441895b107371eec74"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2444432231","pubTimestamp":1718716860,"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Aerovate Therapeutics’ AVTE shares plummeted 93.3% in the last trading session on Jun 17 after the company announced disappointing top-line results from the mid-stage portion of the IIb/III IMPAHCT study evaluating its lead candidate, AV-101, in adults with pulmonary arterial hypertension .The mid to late-stage IMPAHCT study evaluated the efficacy, safety and tolerability of three different doses of AV-101 compared with placebo.Per the data readout from the phase IIb portion of the IMPAHCT study, AV-101, a novel dry powder inhaled formulation of imatinib, failed to meet the primary endpoint of change in pulmonary vascular resistance for any of the studied doses.Moreover, treatment with the candidate did not demonstrate any meaningful improvements in the study’s secondary endpoint of change in the six-minute walk distance.Year to date, shares of Aerovate have plunged 92.7% compared with the industry’s 6.4% decline.","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","BK4539":"次新股","ANVS":"Annovis Bio, Inc.","AVTE":"Aerovate Therapeutics, Inc.","CGEN":"Compugen医疗","ALXO":"ALX Oncology Holdings","BK4121":"生命科学工具和服务"},"translate_title":"Aerovate(AVTE)因主要药物未能达到PAH研究目标而下跌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ANVS":1,"AVTE":1,"CGEN":1,"ALXO":0.9},"content_text":"Aerovate Therapeutics’ AVTE shares plummeted 93.3% in the last trading session on Jun 17 after the company announced disappointing top-line results from the mid-stage portion of the IIb/III IMPAHCT study evaluating its lead candidate, AV-101, in adults with pulmonary arterial hypertension (PAH).\nThe mid to late-stage IMPAHCT study evaluated the efficacy, safety and tolerability of three different doses of AV-101 compared with placebo.\nPer the data readout from the phase IIb portion of the IMPAHCT study, AV-101, a novel dry powder inhaled formulation of imatinib, failed to meet the primary endpoint of change in pulmonary vascular resistance for any of the studied doses.\nMoreover, treatment with the candidate did not demonstrate any meaningful improvements in the study’s secondary endpoint of change in the six-minute walk distance.\nThe company has further reviewed data from several additional secondary endpoints of the phase IIb portion of the IMPAHCT study and found no meaningful improvements. Based on such poor outcomes, AVTE has decided, in agreement with the independent study advisory committee, to halt enrollment and shut down both the phase III portion of the study and the associated long-term extension study.\nYear to date, shares of Aerovate have plunged 92.7% compared with the industry’s 6.4% decline.\nImage Source: Zacks Investment Research\nAV-101 was, however, well-tolerated across all dose groups with a favorable safety profile.\nAerovate plans to engage closely with the IMPAHCT study advisory committee and the PAH community in the coming weeks to discuss the data and its implications. The company intends to release the full data from the phase IIb portion at a later, yet-to-be-determined date.\nPAH is a devastating cardiopulmonary disease impacting approximately 70,000 people in the United States and EU.\nThe IMPAHCT study failure news is particularly detrimental to the stock as AV-101 is the company’s only pipeline candidate. This means that there is no other candidate currently under development to which Aerovate can shift its focus.\nAs of the middle of June 2024, Aerovate reported that it has approximately $100 million in cash, cash equivalents and short-term investments.\nThe company also does not have any existing collaborations with other biotech firms from where it can generate funds. On the contrary, the failure of the AV-101 study is expected to make it difficult for Aerovate to find potential collaborators.\nUnder such circumstances, the company is likely to seek buyout offers or seize operations altogether.                                                                                      \n\nAerovate Therapeutics, Inc. Price and Consensus\n\nAerovate Therapeutics, Inc. price-consensus-chart | Aerovate Therapeutics, Inc. Quote\n\nZacks Rank and Stocks to Consider\nAerovate currently carries a Zacks Rank #3 (Hold).\nSome better-ranked stocks from the drug/biotech industry are ALX Oncology Holdings ALXO, Annovis Bio ANVS and Compugen CGEN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.\nIn the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73. Year to date, shares of ALXO have plunged 50.4%.\nALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.\nIn the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95. Year to date, shares of ANVS have plunged 70.5%.\nANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.\nIn the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has increased from 2 cents to 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have lost 1%.\nCGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.\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\nCompugen Ltd. (CGEN) : Free Stock Analysis Report\nAnnovis Bio, Inc. (ANVS) : Free Stock Analysis Report\nALX Oncology Holdings Inc. (ALXO) : Free Stock Analysis Report\nAerovate Therapeutics, Inc. (AVTE) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"","news_tag":"","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":"4.24.2","shortVersion":"4.24.2","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/2444432231"}