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30.11.2020

The FDA had expressed some concerns regarding Twirla's safety, efficacy, and the company's proposed label. However, the AdCom members voted 14-1 with one abstention in favor of approval. AGRX went from trading at 52-week low, to rocketing up to a 52-week high following the positive AdCom vote. PRINCETON, N.J., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) of Twirla(R) (levonorgestrel/ethinyl "敏捷疗法公司(纳斯达克股票代码:AGRX)刚刚证明了这句话的智慧。 2017年12月,Agile就其避孕贴片Twirla收到了美国食品药品监督管理局(FDA)的完整回复信(CRL)。FDA拒绝了该生物技术法规的提交,因为它担心用于制造贴剂的质量附着力测试方法。 Alfred F. Altomari: Currently, Alfred F. Altomari holds the position of Chairman & Chief Executive Officer of Agile Therapeutics, Inc. and Chairman of Baudax Bio, Inc. Mr. Altomari is also on the board of Insmed, Inc., NB Therapeutics, Inc. (former Chairman), BioNJ, Inc. and Trenton Area Soup Kitchen and Director-Charles D Close School at Drexel University.

制药公司Agile Therapeutics(AGRX.US)盘初跌超45%,Q3净亏损同 …

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The FDA had expressed some concerns regarding Twirla's safety, efficacy, and the company's proposed label. However, the AdCom members voted 14-1 with one abstention in favor of approval. AGRX went from trading at 52-week low, to rocketing up to a 52-week high following the positive AdCom vote.

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The FDA had expressed some concerns regarding Twirla's safety, efficacy, and the company's proposed label. However, the AdCom members voted 14-1 with one abstention in favor of approval. AGRX went from trading at 52-week low, to rocketing up to a 52-week high following the positive AdCom vote.

雪球为您提供Agile Therapeutics(AGRX)股票实时行情,资金流向,新闻资讯,研究报告,社区互动,交易信息,个股点评,公告,财务指标分析等与Agile Therapeutics(AGRX)股票相关的信息与服务. 新浪财经-美股频道为您提供agrx(agrx)股票股价,股票实时行情,新闻,财报,美股实时交易数据,研究报告,评级,财务指标分析等与agrx(agrx)股票相关的信息与服务 ”敏捷疗法公司(纳斯达克股票代码:AGRX)刚刚证明了这句话的智慧。 2017年12月,Agile就其避孕贴片Twirla收到了美国食品药品监督管理局(FDA)的完整回复信(CRL)。FDA拒绝了该生物技术法规的提交,因为它担心用于制造贴剂的质量附着力测试方法。 PRINCETON, N.J., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) of Twirla(R) (levonorgestrel/ethinyl The FDA had expressed some concerns regarding Twirla's safety, efficacy, and the company's proposed label. However, the AdCom members voted 14-1 with one abstention in favor of approval. AGRX went from trading at 52-week low, to rocketing up to a 52-week high following the positive AdCom vote.

我们的投资项目 - 维梧资本|专注医疗健康领域的投资公司

【昨日盘后上涨跌】 盘后下跌股票 财报财测影响:AMAG GG LPI CF A SB ABX NLY MRO 成事影响: AMAG/ATRS 发表发出产Makena己触动打针剂用于投降低早产几比值得到FDA经度过认证,同时发表发出产将在本季度提提交Bremelanotide的报户口新药央寻求 $(AGRX)$周三大跌 47% (盘前一度跌去 74% ),因为其激素避孕贴片Twirla在3期安全研究中表现不如人意(并不是完全失败),公司仍然计划在今年上半年向FDA提出上市申请。 $(CTIC)$周四上涨 12% ,因为FDA宣布其治疗血癌的在研药Pacritinib可以恢复试验。 TEVA暴跌很夸张,如果手里还有股票,不用割了,会有反弹。此股目前价位(23左 右)买入,SWING机会。Generic drug板块(TEVA, MYL等)普遍表现欠佳,受医 疗政策影响大,不做长线。 另外,两个股SWING机会: SNAP触底反弹,13以下买入。长线不看好,参考TWTR表现。