PolarityTE Stock Drops On FDA Clinical Hold On SkinTE Trial Application

by Vandana Singh, Benzinga Editor

August 24, 2021 1:17 PM | 1 min read | Make a Comment

The FDA has issued a clinical hold on PolarityTE Inc's 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.