AbbVie's Parkinson's Disease Therapy Hits FDA Roadblock
Portfolio Pulse from Vandana Singh
AbbVie Inc (NYSE:ABBV) received an FDA Complete Response Letter (CRL) for its Parkinson's disease therapy ABBV-951 due to issues at a third-party manufacturer. The CRL does not cite safety, efficacy, or labeling concerns, nor does it request additional trials. ABBV-951 is already approved in 34 countries. AbbVie's stock was down 0.38% following the news.
June 25, 2024 | 1:58 pm
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AbbVie received an FDA CRL for its Parkinson's therapy ABBV-951 due to third-party manufacturing issues. The CRL does not cite safety, efficacy, or labeling concerns, nor does it request additional trials. ABBV-951 is already approved in 34 countries. AbbVie's stock was down 0.38% following the news.
The FDA CRL is a setback for AbbVie's ABBV-951, potentially delaying its US market entry. However, the lack of safety or efficacy concerns and no request for additional trials mitigate the negative impact. The stock's slight decline reflects investor reaction to the regulatory hurdle.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100