5 Top Losers In Healthcare Sector

4月3日医药股跌幅盘点:生物制药公司 Evoke 因新药申请被拒,股价下跌47.06%

2019-04-03 20:34:00 RTTNews

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The following are some of the pharma/biotech stocks that posted the biggest percentage decline today. 1. Evoke Pharma Inc. (EVOK) Lost 47.06% to close Tuesday's (Apr.2) trading at $0.90. News: The Company's investigational drug Gimoti, proposed for the relief of symptoms associated with acute and recurrent diabetic gastroparesis, has been turned down by the FDA. The writing was already written on the wall as the regulatory agency had issued a not-so-favorable preliminary communication related to the Gimoti NDA in March. In the preliminary communication, the FDA had raised concerns in three sections of the Gimoti NDA - Chemistry, Clinical, and Clinical Pharmacology. In the Complete Response Letter, issued on April 1, the FDA has raised issues related to clinical pharmacology and product quality/device quality. The Agency did not request any new clinical data and did not raise any safety concerns. 2. Apyx Medical Corporation (APYX) Apyx Medical, formerly known as Bovie Medical Corp., is a medical device company. Lost 35.83% to close Tuesday's trading at $4.46. News: The Company has voluntarily withdrawn its application for premarket notification 510(k) regulatory clearance of J-Plasma/Renuvion for use in dermal resurfacing procedures. The premarket notification 510(k) was filed last December, and in course of the review, the FDA has raised a number of questions and concerns related to superior clinical results from one investigational center as compared to the other two investigational centers in the study, among others. The Company will continue to work with the FDA relative to the development of a new 510(k) submission. However, a timeline for resubmission has not been provided. 3. IntelGenx Technologies Corp. (IGXT.OB) Lost 22.23% to close Tuesday's trading at $0.52. News: The FDA has refused to approve RIZAPORT, proposed for the treatment of acute migraines, yet again. This is the third time that the regulatory agency is turning down RIZAPORT. The FDA had refused to approve RIZAPORT in 2014, and again in 2017. 4. Meridian Bioscience Inc. (VIVO) Lost 19.32% to close Tuesday's trading at $14.20. News: The Company expects a decline in second fiscal quarter revenue, and also revised down its financial guidance for fiscal 2019. The second fiscal quarter of 2019 revenues are expected to be approximately $50.0 million compared to $56.5 million in the second fiscal quarter of 2018. For the fiscal year ending September 30, 2019, the Company now expects net revenues to be down 3%. Earlier, the Company was expecting revenue to be flat or record a growth of 2%. 5. NovaBay Pharmaceuticals Inc. (NBY) NovaBay is a biopharmaceutical company focusing on commercializing prescription Avenova for the domestic eye care market. Lost 15.65% to close Tuesday's trading at $0.97. News: No news Recent event: On March 28, the Company reported financial results for the fourth quarter and full year ended December 31, 2018. The net loss for the fourth quarter of 2018 was $1.3 million, or $0.07 per share, compared with net income for the fourth quarter of 2017 of $0.8 million, or $0.02 per share. Net sales for the fourth quarter of 2018 dropped to $3.6 million from $6.3 million for the fourth quarter of 2017, with the decrease primarily due to lower insurance reimbursement resulting in a lower average selling price of Avenova, along with a $1.3 million reduction in non-Avenova sales.
以下是一些医药/生物技术类股票,今天跌幅最大。 1。Evoke Pharma Inc .( EVOK ) 周二收盘下跌47.06%,收于0.90美元。 新闻:该公司的研究药物 Gimot ,为缓解与急性和复发性糖尿病胃病相关的症状,已被 FDA 拒绝。 这封信已经写在了墙上,因为监管机构在3月份发布了一份与 Gimot NDA 相关的不太有利的初步沟通。在初步沟通中, FDA 在 Gimot NDA 的三个部分提出了关注-化学,临床和临床药理学。 在4月1日发布的完整回应函中, FDA 提出了与临床药理和产品质量/器械质量相关的问题。该机构没有要求任何新的临床数据,也没有提出任何安全问题。 2。Apyx 医疗公司( APYX ) Apyx Medical ,原名 Bovie Medical Corp .,是一家医疗器械公司。 周二收于4.46美元,下跌35.83%. 新闻:本公司已自愿撤回其申请上市前通知510( k )监管批准的 J-Plama / Renuvion 用于皮肤复苏程序。 去年12月提交了上市前通知510( k ),在审查过程中, FDA 提出了一些问题和关注,与其他两个研究中心相比,一个研究中心的优越临床结果。 公司将继续与 FDA 合作开发新的510( k )提交文件。然而,尚未提供重新提交的时间表。 3。IntlGenx Technologies Corp .( IGXT.OB ) 周二收于0.52美元,下跌22.23%。 新闻: FDA 拒绝批准利扎波特,建议治疗急性偏头痛,但再次。 这是监管机构第三次拒绝 RIZAPORT 。FDA 曾在2014年和2017年拒绝批准 RIZAPORT 。 4。Meridian Bioscience Inc .( VIVO ) 周二收于14.20美元,跌幅19.32%。 新闻:公司预计第二财季收入将出现下滑,同时也下调了2019年的财务指引。 2019年第二财政季度收入预计约为5000万美元,而2018年第二财政季度为5650万美元。截至2019年9月30日的财年,公司预计净收入将下降3%。早些时候,该公司预计收入持平或增长2%。 5。NovaBay Pharmaceuticals Inc .( NBY ) NovaBay 是一家生物制药公司,专注于国内眼科护理市场处方 Avenova 的商业化。 周二收于0.97美元,下跌15.65%. 新闻:没有新闻 近期事件: 于3月28日,本公司报告截至2018年12月31日止第四季度及全年的财务业绩。 2018年第四季度的净亏损为130万美元,即每股0.07美元,而2017年第四季度的净利润为80万美元,即每股0.02美元。 2018年第四季度的净销售额从2017年第四季度的630万美元降至360万美元,下降的主要原因是保险报销减少导致 Avenova 平均售价降低,以及非 Avenova 销售额减少130万美元。

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