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 Theraptics 宣布反向股票分割，監管更新領導其疼痛候選人
- 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.
- 大道治療公司 (NASDAQ: ATXI) 收到 FDA 的官方會議紀錄，內容涉及為四曲馬多與其他阿片類鎮痛藥組合進行的會議，以管理中度至中度嚴重疼痛。
- 在會議上，Avenue 提出了一項針對單一安全臨床試驗的研究設計，該試驗認為該試驗可以解決與阿片類藥物堆疊相關的風險的擔憂。
- 食品和藥物管理局表示，擬議的研究設計看起來合理，並同意預期在檢討更詳細的研究方案後，向 Avenue 提供額外的回饋意見。
- 該公司打算提交詳細的研究協議，該協議可能成為提交對 IV 曲馬多第二次完整響應信的完整回复的基礎。
- 今年 2 月，FDA 的 AdComm 表示，大道治療學提交了不足的數據。
- 2021 年 6 月，Avenue 治療學收到了 FDA 發出的第二封完整回應函，內容涉及其尋求批准 IV 曲馬多的營銷申請。
- 同時，大道治療學宣布將影響 1 對 15 的反向股票分割。
- 反向股票分割後，股票數量將從 22.7 萬減少到 150 萬股。
- 價格行動： ATXI 在上次檢查週五的上市前時段下跌 29.5%，為 4.65 美元。
譯文內容由第三人軟體翻譯。
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
風險及免責聲明
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
我知道了
風險及免責聲明
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
我知道了
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