Delay Hits Humacyte's Bioengineered Human Tissue Implant For Vascular Trauma Injuries, FDA Extends Time To Review
Portfolio Pulse from Vandana Singh
The FDA has announced a delay in the review of Humacyte Inc.'s Biologic License Application for its acellular tissue-engineered vessel (ATEV) for vascular trauma injuries. The original PDUFA date was August 10, 2024, but the new action date is currently undisclosed. This delay has caused Humacyte's stock to drop by 8.98% in premarket trading.
August 12, 2024 | 1:21 pm
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The FDA has delayed the review of Humacyte's Biologic License Application for its acellular tissue-engineered vessel (ATEV) for vascular trauma injuries. This delay has led to an 8.98% drop in Humacyte's stock price during premarket trading.
The delay in the FDA review process introduces uncertainty regarding the approval timeline for Humacyte's ATEV, which is critical for the company's future revenue and market position. This uncertainty has negatively impacted investor sentiment, resulting in a significant drop in the stock price.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100