PolarityTE Stock Drops On FDA Clinical Hold On SkinTE Trial Application
- The FDA has issued a clinical hold on PolarityTE Inc's (NASDAQ: PTE) SkinTE Investigational New Drug Application (IND) for chronic cutaneous ulcers.
- The FDA provided feedback on certain Chemistry, Manufacturing, and Control (CMC) items that need to be addressed before proceeding with a pivotal study.
- Related: PolarityTE's SkinTE Meets Primary, Secondary Endpoints In Diabetic Foot Ulcer Trial
- Following standard practice and regulations, the FDA has advised that it will issue a clinical hold letter providing details on the hold to the Company by September 21.
- In May, PolarityTE Announced SkinTE Transitioning To BLA Pathway.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: PTE shares are down 10.20% at $0.75 during the market session on the last check Tuesday.
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