U.S. FDA declines to approve BeyondSpring's neutropenia drug, shares plunge

Reuters2021-12-02

Dec 1 (Reuters) - BeyondSpring Inc(BYSI.O)said on Wednesday the U.S. Food and Drug Administration (FDA) had declined to approve its drug candidate for prevention of chemotherapy-induced neutropenia, ...

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BeyondSpring Inc(BYSI.O)said on Wednesday the U.S. Food and Drug Administration (FDA) had declined to approve its drug candidate for prevention of chemotherapy-induced neutropenia, ...</p>\n\n<a href=\"https://www.reuters.com/business/healthcare-pharmaceuticals/beyondspring-says-us-fda-declined-approve-neutropenia-prevention-drug-2021-12-01/\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BYSI","symbol_name":"万春药业","start_time":0,"source_url":"https://www.reuters.com/business/healthcare-pharmaceuticals/beyondspring-says-us-fda-declined-approve-neutropenia-prevention-drug-2021-12-01/","article_id":"1126563366","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1126563366","pubTimestamp":1638421637,"sourceInfo":null,"weMediaInfo":null,"summary":"Dec 1 (Reuters) - BeyondSpring Inc(BYSI.O)said on Wednesday the U.S. Food and Drug Administration (F","collect":0,"end_time":0,"defaultTopTitle":"reuters.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BYSI":"万春药业"},"translate_title":"美国FDA拒绝批准BeyondSpring的中性粒细胞减少药物，股价暴跌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"BYSI":0.9},"content_text":"Dec 1 (Reuters) - 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Thanks","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":1,"repostSize":0,"link":"https://laohu8.com/post/603599287","repostId":1126563366,"repostType":4,"repost":{"id":"1126563366","pubTimestamp":1638421637,"share":"https://www.laohu8.com/m/news/1126563366?lang=&edition=full","pubTime":"2021-12-02 13:07","market":"us","language":"en","title":"U.S. FDA declines to approve BeyondSpring's neutropenia drug, shares plunge","url":"https://stock-news.laohu8.com/highlight/detail?id=1126563366","media":"Reuters","summary":"Dec 1 (Reuters) - BeyondSpring Inc(BYSI.O)said on Wednesday the U.S. Food and Drug Administration (F","content":"<p>Dec 1 (Reuters) - BeyondSpring Inc(BYSI.O)said on Wednesday the U.S. Food and Drug Administration (FDA) had declined to approve its drug candidate for prevention of chemotherapy-induced neutropenia, citing need for an additional study, sending its shares down nearly 61%.</p>\n<p>The regulator indicated that results from the company's late-stage trial did not provide enough evidence on the benefits of the drug, plinabulin, and that a second trial would be required to support the marketing application, the company said.</p>\n<p>\"BeyondSpring's prospect to profitability is solely reliant on the clinical, regulatory, and commercial success of plinabulin,\" William Blair analyst Andy Hsieh said, downgrading the company to \"market perform\" factoring in the capital investment and time needed to conduct a second late-stage trial.</p>\n<p>Neutropenia, a decrease in the number of white blood cells (WBCs) is a common complication of chemotherapy that kills healthy WBCs along with cancer cells, increasing a patient's susceptibility to infections.</p>\n<p>About 60,000 cancer patients in the United States are hospitalized with the condition and 4,000 die of fever associated with neutropenia, according to the U.S. Centers for Disease Control and Prevention.</p>\n<p>BeyondSpring said in November last year plinabulin 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href=https://www.reuters.com/business/healthcare-pharmaceuticals/beyondspring-says-us-fda-declined-approve-neutropenia-prevention-drug-2021-12-01/><strong>Reuters</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Dec 1 (Reuters) - BeyondSpring Inc(BYSI.O)said on Wednesday the U.S. Food and Drug Administration (FDA) had declined to approve its drug candidate for prevention of chemotherapy-induced neutropenia, ...</p>\n\n<a href=\"https://www.reuters.com/business/healthcare-pharmaceuticals/beyondspring-says-us-fda-declined-approve-neutropenia-prevention-drug-2021-12-01/\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"BYSI":"万春药业"},"source_url":"https://www.reuters.com/business/healthcare-pharmaceuticals/beyondspring-says-us-fda-declined-approve-neutropenia-prevention-drug-2021-12-01/","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1126563366","content_text":"Dec 1 (Reuters) - BeyondSpring Inc(BYSI.O)said on Wednesday the U.S. Food and Drug Administration (FDA) had declined to approve its drug candidate for prevention of chemotherapy-induced neutropenia, citing need for an additional study, sending its shares down nearly 61%.\nThe regulator indicated that results from the company's late-stage trial did not provide enough evidence on the benefits of the drug, plinabulin, and that a second trial would be required to support the marketing application, the company said.\n\"BeyondSpring's prospect to profitability is solely reliant on 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