Mallinckrodt (NYSE:MNK) news coming out on Monday include positive results from a recent clinical trial.
Mallinckrodt notes that the results from its Phase 3 clinical trial of StrataGraft saw it outperform autografting for burn wounds by a significant amount. This includes areas treated with the regenerative tissue needing less autografting after three months.
Another bright point from the Mallinckrodt news has to do with StrataGraft showing strong durable wound closure results. These were better than the pre-defined threshold that the company was comparing against.
Due to the positive Mallinckrodt news, the company says that it will be submitting a Biologics License Application to the U.S. Food and Drug Administration (FDA) for StrataGraft. It plans to do this during the first half of 2020.
It’s worth pointing out that autografting is the standard procedure that many burn victims go through to restore their skin. With it being the normal treatment, the results from the clinical trial show that there is real potential for StrataGraft due to it outdoing it.
Dr. James H. Holmes IV, study co-lead investigator and Director of Wake Forest Baptist Medical Center’s Burn Center, has this to say about the clinical trial.
“The positive top-line results of the Phase 3 trial suggest that this investigational regenerative tissue, if approved, could provide burn surgeons with an alternative treatment option for deep partial-thickness burns.”
MNK stock was up as much as 18.89% early Monday morning, but is largely unchanged from yesterday’s close as of the afternoon.
As of this writing, William White did not hold a position in any of the aforementioned securities.