FDA Approves PolarityTE's Phase 3 Study Of SkinTE In Chronic Cutaneous Ulcer

The FDA has signed off PolarityTE Inc's PTE investigational new drug (IND) application to evaluate SkinTE to treat chronic cutaneous ulcers. 

• This follows the Company satisfactorily addressing clinical hold items that the FDA had previously identified. 
• The approval enables PolarityTE to commence the first of two expected pivotal studies needed to support a biologics license application (BLA) seeking a chronic cutaneous ulcer indication for SkinTE. 
• Related: PolarityTE Stock Drops On FDA Clinical Hold On SkinTE Trial Application.
• The first planned pivotal study is a multi-center, randomized controlled trial evaluating SkinTE for Wager 2 diabetic foot ulcers (DFUs).
• The Company plans to enroll up to 100 patients to compare treatment with SkinTE plus the standard-of-care to the standard-of-care alone. 
• Related content: Benzinga's Full FDA Calendar.
• The Company expects enrollment to begin later in Q1 or early Q2.
• Price Action: PTE shares are down 8.31% at $0.66 during the market session on the last check Tuesday.