Mallinckrodt Starts Rolling BLA Filing for StrataGraft Tissue

Zacks Equity Research

Mallinckrodt plc MNK announced that it has initiated the rolling submission of a biologics license application (BLA) to the FDA for its investigational product, StrataGraft regenerative skin tissue, to treat adults with deep partial-thickness thermal burns.

The BLA is based on data from the pivotal phase III STRATA2016 clinical study with support from the STRATA2011 clinical study. The company expects to complete the BLA submission in the coming months.

If approved, StrataGraft skin tissue can be a potential new treatment option for the given patient population.

Shares of Mallinckrodt were up 5.3% following the aforementioned news on Monday. However, the stock has plunged 48.8% so far this year compared with the industry’s decrease of 17.7%.

We remind investors that in September 2019, Mallinckrodt announced positive top-line results from a late-stage study on StrataGraft regenerative skin tissue for the treatment of deep partial-thickness thermal burns.

The study, which met both primary endpoints, evaluated the efficacy and safety of a single application of StrataGraft regenerative skin tissue for the given indication.

Mallinckrodt plans to evaluate StrataGraft skin tissue for the treatment of adults with full-thickness burns (also known as third-degree burns). The company also plans to evaluate StrataGraft skin tissue for addressing the pediatric patient population.

Meanwhile, last month, Mallinckrodt completed the rolling submission of the new drug application (NDA) seeking approval for its pipeline candidate, terlipressin, as a treatment of hepatorenal syndrome type 1 (HRS-1). The life-threatening syndrome involves acute kidney failure in cirrhosis patients.

Terlipressin is not approved for any indication in the United States and Canada. However, it secured a nod for treating HRS-1 outside these two countries. A potential approval of terlipressin in the United States will be a huge boost to the company.

Zacks Rank & Stocks to Consider

Mallinckrodt currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Acorda Therapeutics, Inc. ACOR, Abeona Therapeutics Inc. ABEO and Celldex Therapeutics, Inc. CLDX, all sporting a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

Acorda’s loss per share estimates have been narrowed 8.8% for 2020 and 11.1% for 2021 over the past 60 days.

Abeona’s loss per share estimates have been narrowed 21.5% for 2020 and 16.8% for 2021 over the past 60 days.

Celldex’s loss per share estimates have been narrowed 12.5% for 2020 and 12.8% for 2021 over the past 60 days.

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