Favorable VLA1553-321 Phase 3 Study Results Boost VALN Stock

Zacks01-21 20:05

Valneva SE VALN, a specialty vaccine company, recently reported positive Phase 3 - VLA1553-321 data in adolescents (12 to 17 years old) for its single-shot chikungunya virus (CHIKV) vaccine, IXCHIQ. ...

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For investors’ note, IXCHIQ is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need.The trial data supports and strengthens the pivotal data previously reported for adolescents in the United States, Europe and Canada. Data from this trial are also expected to support the licensure of IXCHIQ in Brazil.The new favorable data from the Phase 3 trial helped Valneva advance the furthest along the clinical development timeline.Subsequent to the news, the share price of VALN jumped 1.4% to $4.37 yesterday.The latest development is capable of generating positive market sentiment, considering the rising number of chikungunya cases in select geographies. We therefore expect market sentiment toward VALN stock to be positive surrounding this news.Additionally, the compan","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4548":"巴美列捷福持仓","INRLF":"Valneva SE","OMCL":"Omnicell","BK4539":"次新股","CEPI":"REX CRYPTO EQUITY PREMIUM INCOME ETF","BK4567":"ESG概念","BK7007":"医疗保健设备","VALN":"Valneva SE","BK4585":"ETF&股票定投概念","BK4139":"生物科技","RMD.AU":"Resmed DRC","BK4082":"医疗保健设备","BK4167":"医疗保健技术","VCYT":"Veracyte Inc","LU2177674079.SGD":"Fidelity Asia Pacific Opportunities A-ACC-SGD (hedged)","BK4588":"碎股","RMD":"瑞思迈","LU2008162690.USD":"FIDELITY FUNDS - ASIA PACIFIC OPPORTUNITIES \"A\" (USD) ACC","BK7501":"新冠治疗股","BK4156":"煤与消费用燃料","BK4504":"桥水持仓"},"translate_title":"有利的VLA1553-321 3期研究结果提振了VALN库存","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"VCYT":1,"VALN":1,"RMD":1,"OMCL":1,"CEPI":1,"RMD.AU":0.9,"INRLF":0.9},"content_text":"Valneva SE VALN, a specialty vaccine company, recently reported positive Phase 3 - VLA1553-321 data in adolescents (12 to 17 years old) for its single-shot chikungunya virus (CHIKV) vaccine, IXCHIQ. For investors’ note, IXCHIQ is the world’s first and only licensed chikungunya vaccine available to address this significant unmet medical need. \nThe trial data supports and strengthens the pivotal data previously reported for adolescents in the United States, Europe and Canada. Data from this trial are also expected to support the licensure of IXCHIQ in Brazil. \nThe new favorable data from the Phase 3 trial helped Valneva advance the furthest along the clinical development timeline.\nImpact of the News on VALN Stock\nSubsequent to the news, the share price of VALN jumped 1.4% to $4.37 yesterday.\nThe latest development is capable of generating positive market sentiment, considering the rising number of chikungunya cases in select geographies. We therefore expect market sentiment toward VALN stock to be positive surrounding this news.\nValneva boasts a market capitalization of $346.6 million. The company is estimated to report 8.3% earnings growth in 2024.\nAbout VALN’s Favorable Phase 3 Trial Data\nThe one-year VLA1553-321 data showed that a single-dose vaccination induced a high, sustained immune response in an immunogenicity subset of participants who were CHIKV negative at baseline, with a seroresponse rate of 98.3% one year after vaccination. The results complement the long-term persistence data previously reported for adults, confirming a strong and long-lasting antibody response to the vaccine. \nAdditionally, the one-year data confirmed that a single dose of the vaccine was generally well tolerated in adolescents. Throughout the trial, an Independent Data Safety Monitoring Board consistently assessed safety data and found no safety issues.\nAbout Phase 3 Study VLA1553-321\nVLA1553-321 is a prospective, double-blinded, multicenter, randomized, placebo-controlled pivotal Phase 3 trial conducted in 754 adolescents in Brazil. \nThe trial was conducted in collaboration with Instituto Butantan in Brazil and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the European Union (EU)’s Horizon 2020 program, the VLA1553-321 trial, which represents the first clinical trial conducted in an endemic area and upon individuals previously infected with CHIKV.\nRecent Global Expansion of VALN\nThe FDA application complements the recent label extension submissions to the European Medicines Agency and Health Canada, highlighting Valneva’s strategic push to enhance IXCHIQ’s global reach. \nImage Source: Zacks Investment Research\nAdditionally, the company is actively pursuing marketing authorization in Brazil and expanding collaborations with CEPI to improve vaccine access in low and middle-income countries. Data from the Phase 3 trial may support regulatory approval of the vaccine in Brazil and other countries in Latin America.\nAddressing a Growing Public Health Threat\nChikungunya’s geographical spread, exacerbated by climate change, underscores the urgency of accessible vaccines. With more than 3.7 million cases reported in the Americas alone over the past decade, the disease imposes significant medical and economic burdens. Valneva’s advancements with IXCHIQ reinforce its leadership in specialty vaccines, offering hope for mitigating this escalating global health challenge.\nBy expanding IXCHIQ’s reach and demonstrating its long-term efficacy, Valneva solidifies its position as a key player in combating emerging infectious diseases.\nShare Price Performance of VALN\nOver the past three years, shares of VALN have plummeted 42.3% against the industry’s 9.5% growth.\nZacks Rank of Valneva and Key Picks\nValneva currently carries a Zacks Rank #3 (Hold).\nSome better-ranked stocks in the broader medical space are Veracyte VCYT, ResMed RMD and Omnicell OMCL.\nVeracyte, carrying a Zacks Rank #1 (Strong Buy) at present, has an estimated earnings growth rate of 65.8% for 2025. You can see the complete list of today’s Zacks #1 Rank stocks here.\nVCYT’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 520.58%. Veracyte’s shares have risen 49.2% in the past year compared with the industry’s 5.5% growth.\nResMed, carrying a Zacks Rank #2 (Buy) at present, has an estimated growth rate of 21.1% for 2025. RMD’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 6.41%. Its shares have risen 34.1% compared with the industry’s 7.7% growth in the past year. \nOmnicell, carrying a Zacks Rank #2 at present, has an estimated earnings growth rate of 72.7% for fourth-quarter 2024. Its earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 121.74%. OMCL’s shares have risen 26.4% against the industry’s 15.7% decline in the past year. \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\nOmnicell, Inc. (OMCL) : Free Stock Analysis Report\nResMed Inc. (RMD) : Free Stock Analysis Report\nVeracyte, Inc. (VCYT) : Free Stock Analysis Report\nValneva SE Sponsored ADR (VALN) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","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":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/2505278755"}