Mallinckrodt Wins FDA Approval For Its Regenerative Skin Burn Graft

Following four months of regulatory delays amid the COVID-19 pandemic, the FDA has finally approved Mallinckrodt Plc's MNKKQ regenerative tissue graft for the treatment of second-degree burns.
The StrataGraft product is made from two kinds of human skin cells grown together to provide a layered scaffold that gives the patient's skin a place to grow as the body heals from the injury, also referred to as a deep partial-thickness burn.
The goal of the treatment is to help reduce the amount of the patient's own healthy skin needed for a surgical graft.
At the time, the company said it was moving forward with studies of StrataGraft under an expanded access program.
This project was funded in part with $86 million from the Biomedical Advanced Research and Development Authority (BARDA) to develop StrataGraft.
Price Action: MNKKQ closed at $0.34 on Tuesday.