Roivant Sciences' Mosliciguat Granted Orphan Drug Designation in Japan

MT Newswires Live

Sep 04

Roivant Sciences (ROIV) said Thursday that Japan's Ministry of Health, Labor and Welfare has granted orphan drug designation for mosliciguat, a potential treatment for pulmonary hypertension associated with interstitial lung disease.

The designation is intended to provide key regulatory and development incentives, including priority consultation, reduced regulatory fees, and up to 10 years of market exclusivity.

The company said mosliciguat is currently being evaluated in a phase 2 clinical study of approximately 120 adult patients.

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.

Most Discussed

{"basename":"","ssrTDKData":{"titleTemplate":"%s - Tiger Brokers","title":"Tiger Brokers | Global Stocks, Options & Futures Trading App","description":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","keywords":"tiger brokers,tiger trade,tiger brokers singapore,broker online,stock trading in singapore,share trading singapore,brokerage firm singapore,trading app,stock broker singapore,stock trading platforms,trading account","social":{"ogDescription":"Tiger Brokers, one-stop investment in US stocks, SGX stocks, HK stocks, A-shares & other global assets. One of the best stock trading platforms in Singapore.","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/news/2564037168"},"companyName":"Tiger Brokers"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2564037168\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2564037168?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-09-04 19:46","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2564037168","market":"hk","top_or_hot":-1,"title":"Roivant Sciences' Mosliciguat Granted Orphan Drug Designation in Japan","media":"MT Newswires Live","content":"<html><body><p> Roivant Sciences (ROIV) said Thursday that Japan's Ministry of Health, Labor and Welfare has granted orphan drug designation for mosliciguat, a potential treatment for pulmonary hypertension associated with interstitial lung disease.</p><p>The designation is intended to provide key regulatory and development incentives, including priority consultation, reduced regulatory fees, and up to 10 years of market exclusivity.</p><p>The company said mosliciguat is currently being evaluated in a phase 2 clinical study of approximately 120 adult patients.</p></body></html>","source":"mtnewswires_news","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>Roivant Sciences' Mosliciguat Granted Orphan Drug Designation in Japan</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\">\nRoivant Sciences' Mosliciguat Granted Orphan Drug Designation in Japan\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1092851196\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">MT Newswires Live </p>\n<p class=\"h-time\">2025-09-04 19:46</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> Roivant Sciences (ROIV) said Thursday that Japan's Ministry of Health, Labor and Welfare has granted orphan drug designation for mosliciguat, a potential treatment for pulmonary hypertension associated with interstitial lung disease.</p><p>The designation is intended to provide key regulatory and development incentives, including priority consultation, reduced regulatory fees, and up to 10 years of market exclusivity.</p><p>The company said mosliciguat is currently being evaluated in a phase 2 clinical study of approximately 120 adult patients.</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"ROIV","symbol_name":"Roivant Sciences Ltd.","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2564037168","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2564037168","pubTimestamp":1756986418,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. Better news, better service, better price.","home_visible":1,"id":"1092851196","head_image":"https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e"},"summary":"Roivant Sciences  said Thursday that Japan's Ministry of Health, Labor and Welfare has granted orphan drug designation for mosliciguat, a potential treatment for pulmonary hypertension associated with interstitial lung disease.The designation is intended to provide key regulatory and development incentives, including priority consultation, reduced regulatory fees, and up to 10 years of market exclusivity.The company said mosliciguat is currently being evaluated in a phase 2 clinical study of approximately 120 adult patients.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"ROIV":"Roivant Sciences Ltd.","BK4007":"制药","BK4139":"生物科技"},"translate_title":"Roivant Sciences的Mosliciguat在日本获得孤儿药资格","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ROIV":0.9},"content_text":"Roivant Sciences (ROIV) said Thursday that Japan's Ministry of Health, Labor and Welfare has granted orphan drug designation for mosliciguat, a potential treatment for pulmonary hypertension associated with interstitial lung disease.The designation is intended to provide key regulatory and development incentives, including priority consultation, reduced regulatory fees, and up to 10 years of market exclusivity.The company said mosliciguat is currently being evaluated in a phase 2 clinical study of approximately 120 adult patients.","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":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"}}}