Stock Alert: Y-mAbs Therapeutics Slips 7%

股票预警:Y-mAbs Therapeutics下跌7%

2020-10-07 00:01:26 RTTNews

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Shares of Y-mAbs Therapeutics Inc. further slipped 7% on Tuesday morning after plunging nearly 20% in extended trading Monday. The late-stage clinical biopharmaceutical company hit a roadblock after FDA refused to accept for review its investigational drug Omburtamab's Biologics License Application. YMAB is currently trading at $38.64, down $3.06 or 7.34%, on the Nasdaq. The company completed the submission of its Biologics License Application for Omburtamab, proposed for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma in August this year. However, upon preliminary review, the FDA wanted further details. The regulator refused to accept for review the Omburtamab BLA and issued a Refusal to File letter for Y-mAbs Therapeutics. The company now targets to resubmit an amended BLA before the end of 2020. For comments and feedback contact: editorial@rttnews.com Business News
Y-mAbs Therapeutics Inc.的股价在周一延长交易时段暴跌近20%后,周二上午进一步下跌7%。在FDA拒绝接受其研究药物omburtamab的生物制品许可申请进行审查后,这家处于晚期临床生物制药公司遇到了障碍。 YMAB目前在纳斯达克的交易价格为38.64美元,下跌3.06美元或7.34%。 该公司于今年8月完成了Omburtamab的生物制剂许可证申请,该产品拟用于治疗神经母细胞瘤中枢神经系统/软脑膜转移的儿科患者。 然而,在初步审查后,FDA想要更多的细节。监管机构拒绝接受对Omburtamab BLA的审查,并发出了拒绝为Y-mAbs Therapeutics提交文件的信函。 该公司现在的目标是在2020年底之前重新提交一份修订后的BLA。 如需评论和反馈,请联系:editorial@rttnews.com 商业新闻

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