What's Going On With Moderna, Capricor, Other Biotech Stocks On Monday?

Benzinga03-10

The U.S. Food and Drug Administration Commissioner Marty Makary confirmed on Friday that Dr. Vinay Prasad, head of its Center for Biologics Evaluation and Research (CBER), is set to leave his position...

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Why is MRNA stock advancing?\nCBER is responsible for evaluating a wide spectrum of treatments, including cancer drugs, gene therapies and vaccines.\nSeveral controversial decisions marked his tenure.\nWilliam Blair on Monday wrote that investors are positive on the news, given Dr. Prasad's “idiosyncratic decisions and interventions on drug reviews…”\nuniQure N.V. (NASDAQ:QURE) is trading up, given Dr. Prasad's involvement in denying an expedited review path for AMT-130 gene therapy in Huntington's disease, despite substantial patient and clinician lobbying\nWilliam Blair analyst Matt Phipps wrote that Dr. Prasad personally signed the CRL; thus, his resignation could be viewed as a tailwind for rare disease sponsors looking to use single-arm studies and external controls as a potential regulatory approval path.\nWith Dr. Prasad's departure, William Blair wrote that Moderna's mRNA-1010 could qualify for full approval in adults 65 and older. The approval could potentially spare the company from conducting an additional, costly vaccine efficacy study.\nSolid Biosciences Inc (NASDAQ:SLDB) stock is up 12.15% at $7.57.\nCapricor Therapeutics Inc. (NASDAQ:CAPR) stock is up 9.07%.\nCrispr Therapeutics AG (NASDAQ:CRSP) stock is up 2.80% at $58.08.\nSarepta Therapeutics Inc. (NASDAQ:SRPT) stock is up 4.31% at $17.43.\nImage via Shutterstock\nTo add Benzinga News as your preferred source on Google, click here.","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","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/2618675478","isCrawlerRequest":true}