Healios K.K Gets FDA Nod for Global ARDS Phase 3 Trial; Shares Up 10%

MT Newswires Live

Sep 10, 2024

Healios K.K (TYO:4593), a biotech firm specializing in regenerative medicine, has secured FDA approval for its global Phase 3 trial, "REVIVE-ARDS," to test MultiStem for acute respiratory distress syndrome (ARDS) caused by pneumonia, according to a Monday filing on the Tokyo Stock Exchange.

The trial will use ventilator-free days as the primary endpoint and include interim analyses of 300 and 400 patients, with a maximum of 550 participants.

The company will finalize study details and consult Japanese regulators for conditional approval based on previous positive Phase 2 results. Shares of the company were up 10% in recent trade.

Price (JPY): $236.00, Change: $+22, Percent Change: +10.28%

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Shares Up 10% Healios K.K (TYO:4593), a biotech firm specializing in regenerative medicine, has secured FDA approval for its global Phase 3 ...</p>\n\n<a href=\"https://www.mtnewswires.com/\">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":"ARDS","symbol_name":"Aridis制药","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2466532175","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2466532175","pubTimestamp":1725938321,"columns":[],"sourceInfo":{"source_id":"mtnewswires_live","name":"MT Newswires Live"},"weMediaInfo":null,"summary":"Healios K.K Gets FDA Nod for Global ARDS Phase 3 Trial; Shares Up 10% Healios K.K (TYO:4593), a biot","collect":0,"end_time":0,"defaultTopTitle":"mtnewswires.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"ARDS":"Aridis制药","TYO":"3倍做空7-10年期国债ETF-Direxion","BK4139":"生物科技"},"translate_title":"Healios K.K获得FDA批准进行全球ARDS 3期试验；股价上涨10%","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ARDS":1,"TYO":1},"content_text":"Healios K.K Gets FDA Nod for Global ARDS Phase 3 Trial; 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