AbbVie's Parkinson's Disease Therapy Hits FDA Roadblock

Tuesday, AbbVie Inc 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.

In its letter, the FDA cited observations identified during the inspection of a third-party manufacturer listed in the New Drug Application (NDA).

The inspection at the facility did not involve ABBV-951 or any AbbVie medicine.

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The CRL does not identify any issues related to the safety, efficacy or labeling of ABBV-951, including the device.

The CRL does not request that AbbVie conduct additional efficacy and safety trials related to the drug or device-related testing.

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 has been approved in 34 countries, and over 2,100 patients worldwide have started treatment.

AbbVie’s 2024 Stock Prediction

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.

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.

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.

Price Action: At last check Tuesday, ABBV shares were down 0.38% at $172.09.

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