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Mallinckrodt Closes Rolling BLA Filing for StrataGraft Tissue

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Mallinckrodt plc  announced that its subsidiary, Stratatech, has completed the rolling submission of a biologics license application (BLA) for its investigational product, StrataGraft a regenerative skin tissue to treat deep partial-thickness thermal burns.

The BLA is based on data from the pivotal phase III STRATA2016 and the STRATA2011 clinical studies. We remind investors that in September 2019, Mallinckrodt announced positive top-line results from the pivotal STRATA2016 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.

Shares of Mallinckrodt have lost 14.1% so far this year compared with the industry’s decline of 0.7%.

The FDA granted StrataGraft skin tissue the Orphan Drug status in 2012 for the treatment of partial and full-thickness skin burns.

Notably, the Orphan Drug designation is granted to drugs that are capable of treating rare diseases that affect less than 200,000 people in the United States. This tag also makes the company entitled to certain other benefits, including tax credits related to clinical trial expenses and an exemption from the FDA user fee.

Mallinckrodt also plans to evaluate StrataGraft skin tissue for the treatment of adults with full-thickness burns (also known as third-degree burns). Further, the company plans to evaluate StrataGraft skin tissue for treating pediatric patients.

Meanwhile, in March 2020, Mallinckrodt completed the rolling submission of the new drug application (NDA) seeking approval for its pipeline candidate, terlipressin, as a treatment for hepatorenal syndrome type 1 (HRS-1). This life-threatening syndrome involves acute kidney failure in cirrhosis patients.

Terlipressin is not approved for any indication in the United States and Canada. A potential approval of the candidate in the United States will be a huge boost for the company.

 

Zacks Rank & Stocks to Consider

Mallinckrodt currently carries a Zacks Rank #3 (Hold).

Better-ranked stocks in the healthcare sector include Adamas Pharmaceuticals, Inc. (ADMS - Free Report) , Assembly Biosciences Inc. (ASMB - Free Report) , and Amphastar Pharmaceuticals, Inc. (AMPH - Free Report) , all sporting a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Adamas’ loss per share estimates have narrowed 1.4% for 2020 over the past 60 days.

Assembly Biosciences’ loss per share estimates have narrowed 20.6% for 2020 and 16.38% for 2021 over the past 60 days.

Amphastar’s earnings per share estimates have increased 3.7% for 2020 over the past 60 days.

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