AbbVie's Parkinson's Disease Therapy Hits FDA Roadblock
AbbVie's Parkinson's Disease Therapy Hits FDA Roadblock
Tuesday, AbbVie Inc (NYSE:ABBV) announced it received an FDA Complete Response Letter (CRL) for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease.
艾伯維公司（NYSE:ABBV）週二宣佈，其新藥申請（NDA）ABBV-951（嘧哆酸腎上腺素/嘧哆酚）用於治療成人晚期帕金森病的運動波動被FDA拒絕，理由是第三方製造商存在審查中發現的問題。
In its letter, the FDA cited observations identified during the inspection of a third-party manufacturer listed in the New Drug Application (NDA).
FDA在信中提到了在新藥申請書（NDA）中列出的第三方製造商的檢查中發現的問題。
The inspection at the facility did not involve ABBV-951 or any AbbVie medicine.
該設施的檢查沒有涉及ABBV-951或任何艾伯維藥品。
Also Read: AbbVie's Arthritis Drug Humira Retains Market Dominance Despite Biosimilar Competition, Challenges Biosimilar Industry Viability.
還閱讀：儘管面臨生物仿製藥的競爭和挑戰，艾伯維的關節炎藥物Humira仍保持市場霸主地位，考驗着生物仿製藥行業的可行性。
The CRL does not identify any issues related to the safety, efficacy or labeling of ABBV-951, including the device.
CRL沒有指出與ABBV-951的安全性、有效性或標籤有關的任何問題，包括設備。
The CRL does not request that AbbVie conduct additional efficacy and safety trials related to the drug or device-related testing.
CRL沒有要求AbbVie進行與藥物相關的額外療效和安全性試驗或與設備相關的測試。
ABBV-951 (foscarbidopa/foslevodopa) is a solution of carbidopa and levodopa prodrugs for 24-hour continuous subcutaneous infusion for motor fluctuations in adults with advanced Parkinson's disease.
ABBV-951（嘧哆酸腎上腺素/嘧哆酚）是一種卡比多巴和左多巴前體的溶液，用於成人晚期帕金森病的24小時持續皮下注射治療運動波動。
ABBV-951 has been approved in 34 countries, and over 2,100 patients worldwide have started treatment.
ABBV-951已經在34個國家獲得了批准，全球超過2,100名患者已經開始治療。
AbbVie's 2024 Stock Prediction
愛文思控股（AbbVie）2024年股票預測
Equity research analysts on and off Wall Street typically use earnings growth and fundamental research as a form of valuation and forecasting. But many in trading turn to technical analysis as a way to form predictive models for share price trajectory.
公募和私募的投資經理通常會使用收益增長和基本分析作爲估值和預測的形式，但是許多交易者會使用技術面分析作爲制定股價軌跡的預測模型的一種方式。
Some investors look to trends to help forecast where they believe a stock could trade at a certain point in the future. Looking at AbbVie, an investor could make an assessment about a stock's long term prospects using a moving average and trend line. If they believe a stock will remain above the moving average, which many believe is a bullish signal, they can extrapolate that trend into the future using a trend line. For AbbVie, the 200-day moving average sits at $160.27, according to Benzinga Pro, which is below the current price of $171.98. For more on charts and trend lines, see a description here.
一些投資者尋找趨勢來幫助預測他們認爲股票在未來某個時間點的交易價格。在看好股票的200天移動均線和趨勢線的基礎上，投資者可以評估股票的長期前景。如果他們相信股票將保持在移動均線上方，這被認爲是一個看漲的信號，他們可以使用趨勢線將這種趨勢延伸到未來。根據Benzinga Pro的數據，AbbVie的200天移動均線爲160.27美元，低於當前價位171.98美元。有關圖表和趨勢線的更多信息，請參見此處的說明。
Traders believe that when a stock is above its moving average, it is a generally bullish signal, and when it crosses below, it is a more negative signal. Investors could use trend lines to make an educated guess about where a stock could trade at a later date if conditions remain stable.
交易員認爲，當股票價格位於其移動平均線之上時，這通常是一個看好的信號，當其跌破移動平均線時，這是一個更爲負面的信號。投資者可以使用趨勢線來推測在穩定情況下，股票未來可能會交易的位置。
Price Action: At last check Tuesday, ABBV shares were down 0.38% at $172.09.
股票價格：截至上週二，ABBV股價下跌0.38%，報172.09美元。
Photo via Shutterstock
圖片來自shutterstock。
譯文內容由第三人軟體翻譯。