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根據RBC報道,Ocular Therapeutix公司推進與FDA就眼科藥物單項試驗申請的談判。

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-- 根據加拿大皇家銀行資本市場(RBC Capital Markets)週二發布的報告顯示,Ocular Therapeutix (OCUL) 正朝著向美國食品藥品監督管理局(FDA)提交其長效治療濕性年齡相關性黃斑變性藥物axpaxli的上市申請邁進,監管機構已開始就單項試驗審批途徑展開正式討論。 RBC指出,管理層表示,目前正與FDA進行磋商,這使得公司有可能基於其成功的關鍵性研究提交申請,而無需等待預計將於2027年初公佈結果的第二項試驗。 RBC也表示,該公司計劃在6月17日的投資者日活動上提供更多監管和項目的最新進展。 Ocular仍計劃在2027年透過單一試驗審批策略推出axpaxli,RBC重申了其對該藥物「積極的獲益/風險比」的看法。 RBC維持對Ocular股票的「跑贏大盤,投機性風險」評級,目標價為30美元。

Price: $9.84, Change: $+0.13, Percent Change: +1.29%

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