Avenue Therapeutics Announces Reverse Stock Split, Regulatory Update For Lead Its Pain Candidate
Avenue Therapeutics Announces Reverse Stock Split, Regulatory Update For Lead Its Pain Candidate
Avenue Therapeutics宣布反向股票拆分和监管最新情况
- Avenue Therapeutics Inc (NASDAQ:ATXI) received the official meeting minutes from the FDA regarding a meeting conducted for IV Tramadol in combination with other opioid analgesics to manage moderate-to-moderately severe pain.
- At the meeting, Avenue presented a study design for a single safety clinical trial that the company believes could address the concerns regarding risks related to opioid stacking.
- The FDA stated that the proposed study design appears reasonable and agreed with the expectation that additional feedback would be provided to Avenue upon review of a more detailed study protocol.
- The company intends to submit a detailed study protocol that could form the basis for submitting a complete response to the second Complete Response Letter for IV Tramadol.
- In February, FDA's adComm said that Avenue Therapeutics submitted insufficient data.
- In June 2021, Avenue Therapeutics received a second Complete Response Letter from the FDA regarding its marketing application seeking approval for IV tramadol.
- Concurrently, Avenue Therapeutics announced that it would effect a 1-for-15 reverse stock split.
- After the reverse stock split, the number of shares will be reduced from 22.7 million to 1.5 million.
- Price Action: ATXI shares are down 29.5% at $4.65 during the premarket session on the last check Friday.
- Avenue Therapeutics Inc (NASDAQ:ATXI) received the official meeting minutes from the FDA regarding a meeting conducted for IV Tramadol in combination with other opioid analgesics to manage moderate-to-moderately severe pain.
- At the meeting, Avenue presented a study design for a single safety clinical trial that the company believes could address the concerns regarding risks related to opioid stacking.
- The FDA stated that the proposed study design appears reasonable and agreed with the expectation that additional feedback would be provided to Avenue upon review of a more detailed study protocol.
- The company intends to submit a detailed study protocol that could form the basis for submitting a complete response to the second Complete Response Letter for IV Tramadol.
- In February, FDA's adComm said that Avenue Therapeutics submitted insufficient data.
- In June 2021, Avenue Therapeutics received a second Complete Response Letter from the FDA regarding its marketing application seeking approval for IV tramadol.
- Concurrently, Avenue Therapeutics announced that it would effect a 1-for-15 reverse stock split.
- After the reverse stock split, the number of shares will be reduced from 22.7 million to 1.5 million.
- Price Action: ATXI shares are down 29.5% at $4.65 during the premarket session on the last check Friday.
- Avenuetics Inc 纳斯达克股票代码：ATXI）收到了美国食品药品管理局的官方会议纪要，内容涉及为控制中度至中度剧烈疼痛而举行的静脉曲马多与其他阿片类镇痛药联合使用的会议。
- 在会议上，Avenue提出了一项单一安全临床试验的研究设计，该公司认为该试验可以解决与阿片类药物堆叠相关的风险问题。
- 美国食品和药物管理局表示，拟议的研究设计似乎是合理的，并同意在审查更详细的研究方案后向Avenue提供更多反馈的期望。
- 该公司打算提交一份详细的研究方案，该协议可能构成对IV Tramadol第二封完整回复信提交完整答复的基础。
- 2月，美国食品药品管理局的AdComm表示，Avenue Therapeutics提交的数据不
- 2021年6月，Avenue Therapeutics收到了美国食品药品管理局的第二封完整回复信，内容涉及其寻求静脉曲马多批准的上市申请。
- 同时，Avenue Therapeutics宣布将进行1比15的反向股票分割。
- 反向股票拆分后，股票数量将从2270万股减少到150万股。
- 价格走势： 在周五的最后一次盘前交易中，ATXI股价下跌29.5％，至4.65美元。
译文内容由第三方软件翻译。
以上内容仅用作资讯或教育之目的，不构成与富途相关的任何投资建议。富途竭力但不能保证上述全部内容的真实性、准确性和原创性。
风险及免责提示
以上内容仅用作资讯或教育之目的，不构成与富途相关的任何投资建议。富途竭力但不能保证上述全部内容的真实性、准确性和原创性。
知道了
风险及免责提示
以上内容仅用作资讯或教育之目的，不构成与富途相关的任何投资建议。富途竭力但不能保证上述全部内容的真实性、准确性和原创性。
知道了
抢沙发
0 0 0
赞大爱笑哭社会社会Emm心碎怒
轻触选择心情
- 分享到weixin
- 分享到qq
- 分享到facebook
- 分享到twitter
- 分享到微博
- 粘贴板
使用浏览器的分享功能，分享给你的好友吧
点击这里分享给好友
暂无评论，快来抢沙发吧！