PharmAust seeks European orphan drug designation for MND/ALS drug monepantel

Small Caps09-17

PharmAust (ASX: PAA) has requested the European Medicines Agency (EMA) grant orphan medicinal product designation (OMPD) for monepantel (MPL), its lead candidate in the treatment of amyotrophic ...

Source Link

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2468087128?lang=en_US&edition=fundamental","thumbnail":"https://cdn.shortpixel.ai/client/w_868,q_lossy,to_auto,ret_wait/https://150309019.v2.pressablecdn.com/wp-content/uploads/2024/09/PharmAust-ASX-PAA-monepantel-FDA-orphan-drug.jpg","is_english":true,"pubTime":"2024-09-17 08:36","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2468087128","market":"hk","top_or_hot":-1,"title":"PharmAust seeks European orphan drug designation for MND/ALS drug monepantel","media":"Small Caps","content":"<div>\n<p>PharmAust (ASX: PAA) has requested the European Medicines Agency (EMA) grant orphan medicinal product designation (OMPD) for monepantel (MPL), its lead candidate in the treatment of amyotrophic ...</p>\n\n<a href=\"https://smallcaps.com.au/pharmaust-european-orphan-drug-designation-mnd-als-drug-monepantel/\">Source Link</a>\n\n</div>\n","source":"smallcap_stock","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>PharmAust seeks European orphan drug designation for MND/ALS drug monepantel</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; 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\">\nPharmAust seeks European orphan drug designation for MND/ALS drug monepantel\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-09-17 08:36 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://smallcaps.com.au/pharmaust-european-orphan-drug-designation-mnd-als-drug-monepantel/><strong>Small Caps</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>PharmAust (ASX: PAA) has requested the European Medicines Agency (EMA) grant orphan medicinal product designation (OMPD) for monepantel (MPL), its lead candidate in the treatment of amyotrophic ...</p>\n\n<a href=\"https://smallcaps.com.au/pharmaust-european-orphan-drug-designation-mnd-als-drug-monepantel/\">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":"BK4156","symbol_name":"煤与消费用燃料","start_time":0,"source_url":"https://smallcaps.com.au/pharmaust-european-orphan-drug-designation-mnd-als-drug-monepantel/","article_id":"2468087128","we_media_id":null,"thumbnails":["https://cdn.shortpixel.ai/client/w_868,q_lossy,to_auto,ret_wait/https://150309019.v2.pressablecdn.com/wp-content/uploads/2024/09/PharmAust-ASX-PAA-monepantel-FDA-orphan-drug.jpg"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2468087128","pubTimestamp":1726533366,"sourceInfo":{"source_id":"smallcap_stock","name":"Small Caps"},"weMediaInfo":null,"summary":"PharmAust  has requested the European Medicines Agency  grant orphan medicinal product designation  for monepantel , its lead candidate in the treatment of amyotrophic lateral sclerosis  and motor neurone disease .The OMPD is an EMA initiative to encourage companies to develop safe and effective treatments for rare diseases or neglected severe disorders.A successful designation can provide incentives such as protocol assistance, central marketing authorisation within the European Union , access to conditional approval and 10 years of market protection from competition with similar medicines for similar indications.The request follows a pre-submission meeting in August with the EMA and the Committee for Orphan Medicinal Products, where PharmAust sought feedback on its application to increase the likelihood of success.“The EU represents an important market for us, where the incidence of ALS is amongst the highest worldwide and affects up to 3.8 patients per 100,000 people,” he said.Pharm","collect":0,"end_time":0,"defaultTopTitle":"smallcaps.com.au","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4156":"煤与消费用燃料","BK7096":"制药","BK7508":"医药生物股","ODD":"ODDITY Tech Ltd.","BK7089":"人寿与健康保险","MPL.AU":"MEDIBANK PRIVATE LTD","MND.AU":"MONADELPHOUS GROUP LTD","BK7055":"建筑与工程","BK4183":"个人用品","BK7501":"新冠治疗股"},"translate_title":"PharmAust为MND/ALS药物monepantel寻求欧洲孤儿药资格","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"MND.AU":1,"MPL.AU":1,"ODD":1,"PAA.AU":1},"content_text":"PharmAust (ASX: PAA) has requested the European Medicines Agency (EMA) grant orphan medicinal product designation (OMPD) for monepantel (MPL), its lead candidate in the treatment of amyotrophic lateral sclerosis (ALS) and motor neurone disease (MND).\nThe OMPD is an EMA initiative to encourage companies to develop safe and effective treatments for rare diseases or neglected severe disorders.\nA successful designation can provide incentives such as protocol assistance, central marketing authorisation within the European Union (EU), access to conditional approval and 10 years of market protection from competition with similar medicines for similar indications.\nCommercial pathway\nThe request follows a pre-submission meeting in August with the EMA and the Committee for Orphan Medicinal Products, where PharmAust sought feedback on its application to increase the likelihood of success.\nPharmAust managing director Dr Michael Thurn said an OMPD would play a critical role in advancing MPL towards commercialisation.\n“The EU represents an important market for us, where the incidence of ALS is amongst the highest worldwide and affects up to 3.8 patients per 100,000 people,” he said.\n“OMPD status will complement a small and medium enterprise status received from the EMA in July [and] we look forward to advising the market of the outcome.”\nPharmAust’s submission will be evaluated over a 90-day period, with a final decision expected before year-end.\nFDA designation\nPharmAust received an orphan drug designation (ODD) in May from the US Food and Drug Administration for the use of MPL in the treatment of ALS and MND.\nThe company will benefit from US incentives including tax credits, grants, a waiver of some administrative fees for clinical trials and seven years of market exclusivity following drug approval.\nPharmAust’s application was based on preclinical mechanistic data which demonstrated MPL could induce autophagy in diseased cells and considered the pathology of the disease.\nThe ODD achievement was referred to as an “outstanding milestone” that would provide a strong pathway forward for the drug.","kind":null,"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":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":"4.29.1","shortVersion":"4.29.1","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/2468087128"}