BUZZ-FDA为膝关节疼痛药物申请扫清障碍后,Organogenesis股价大涨

路透中文
Apr 07
BUZZ-FDA为膝关节疼痛药物申请扫清障碍后,Organogenesis股价大涨

4月7日 - ** Organogenesis ORGO.O股价盘前上涨31%至2.93美元

** ORGO周一晚些时候说,美国食品和药物管理局(FDA)已为其治疗骨关节炎引起的膝关节疼痛的药物ReNu提交上市申请开了绿灯 (link)。

** ORGO表示,FDA同意其现有临床数据支持ReNu的上市申请

** 公司预计将在 12 月底前启动滚动式 BLA 申请

** 另外,该公司表示,其伤口护理产品PuraPly AM在一项试验中达到了主要目标 (link),表明该产品对糖尿病患者顽固足部伤口的愈合效果优于单纯的标准治疗。

** 截至上一交易日收盘,股价年内累计下跌 56%

(为便利非英文母语者,路透将其报导自动化翻译为数种其他语言。由于自动化翻译可能有误,或未能包含所需语境,路透不保证自动化翻译文本的准确性,仅是为了便利读者而提供自动化翻译。对于因为使用自动化翻译功能而造成的任何损害或损失,路透不承担任何责任。)

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