Neurotech bounces back from FDA rejection with new NTI164 baseline study

The Market Herald11-25 07:37

Neurotech (ASX:NTI) has bounced back from a recent fast-track status rejection from the FDA, now launching a NTI164 baseline data study. On October 4, Neurotech flagged to the market the US regulator ...

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Tax credits and reduced overall fees are benefits of winning the status, as well as marketing exclusivity rights.But the FDA in October failed to consider as rare enough Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections  and Paediatric Acute- Onset Neuropsychiatric Syndrome  respectively – the two drugs NTI164 is intended to treat.“Although we have demonstrated long term safety and efficacy of NTI164 in paediatric patients across three separate neurological disorders, a PK study is a requirement for global health regulators, including the U","collect":0,"end_time":0,"defaultTopTitle":"themarketonline.com.au","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4218":"酒店及度假村房地产信托","BK7095":"多种金属与采矿","BK7007":"医疗保健设备","IND.AU":"Industrial Minerals Ltd","NTI.AU":"NEUROTECH INTERNATIONAL LTD","BK4181":"酒店及度假村房地产投资信托","PK":"Park Hotels & Resorts Inc."},"translate_title":"Neurotech通过新的NTI164基线研究从FDA拒绝中恢复过来","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"IND.AU":1,"NTI.AU":1,"PK":1},"content_text":"Neurotech (ASX:NTI) has bounced back from a recent fast-track status rejection from the FDA, now launching a NTI164 baseline data study.\nOn October 4, Neurotech flagged to the market the US regulator FDA had knocked back its application for orphan drug status, effectively a fast-track proviso. \nOrphan drug status is awarded to those compounds seeking to treat rare conditions where few if any treatments are already extant. Tax credits and reduced overall fees are benefits of winning the status, as well as marketing exclusivity rights.\nBut the FDA in October failed to consider as rare enough Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute- Onset Neuropsychiatric Syndrome (PANS) respectively – the two drugs NTI164 is intended to treat. \nData quality was part of the issue, and Neurotech had twelve months to respond. \nOn Monday, we’ve learned it’s now launching a pharmacokinetic (PK) study in healthy adult participants at CMAX Clinical Research in Adelaide to help shore up the company’s overall data offering.\n“Although we have demonstrated long term safety and efficacy of NTI164 in paediatric patients across three separate neurological disorders, a PK study is a requirement for global health regulators, including the US Food and Drug Administration as part of an Investigational New Drug (IND) approval and the Australian Therapeutic Goods Administration,” Neurotech ED Dr. Thomas Duthy said. \nThe company noted that this PK study shouldn’t necessarily get in the way of things on the long-term scale. \n“As part of the necessary documentation to fulfill the requirements under an accelerated provisional application pathway [for the TGA], the study is expected to commence during the current quarter with results in Q1 CY2025,” Duthy added.\nOverall, the study will look at metabolism of the drug, and, excretion data – in other words, how long it stays in the system for.\nNTI last traded at 6.9cps. \nJoin the discussion: See what HotCopper users are saying about Neurotech and be part of the conversations that move the markets.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"Product Release","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":"4.29.3","shortVersion":"4.29.3","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/2486488407"}