Mallinckrodt Shares Rebound On Positive Late-Stage StrataGraft Results

Mallinckrodt PLC MNK shares, which were languishing in recent sessions, were springing back from rock bottom levels Monday. 

What Happened

Mallinckrodt, which is fighting legal challenges — including one against the federal government over Medicaid drug rebates for its Acthar gel — announced positive top-line results from the pivotal Phase 3 study of StrataGraft regenerative tissue in patients with deep partial-thickness thermal burns.

The study evaluated the safety and efficacy of a single application of StrataGraft in the treatment of partial-thickness thermal burns.

StrataGraft, an engineered, bi-layer tissue, is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers that can be sutured, stapled or secured with an adhesive.

The study met both co-primary endpoints with statistical significance, with a significantly smaller area of burn wounds treated with StrataGraft requiring autografting by three months compared to the area of burn wounds treated exclusively with autograft. The proportion of StrataGraft-treated wounds that achieved durable wound closure at three months exceeded the pre-defined threshold for statistical significance, Mallinckrodt said. 

Why It's Important

Autograft, which is the transplanting of surgically harvested healthy skin graft to the injury, is considered a standard of care for deep partial-thickness thermal burns, which are complex skin injuries in which the damage extends through the outermost layer of skin to its innermost layer.

Patients undergoing autograft are left with two wounds to care for, and they also experience pain, itching, scarring and impaired function at the donor site.

"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," Dr. James Holmes, co-lead investigator of the study, said in a statement. 

Based on the Phase 3 data, Mallinckrodt said it expects to submit a BLA to the FDA in the first half of 2020.

The stock was rising by 7.52% to $2.64 at the time of publication Monday. 

Incidentally, the shares plunged to a record low of $1.43 on Sept. 5 on rumors that the company was considering restructuring ahead of the opioid overdose trials.

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