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Mallinckrodt Ends Enrollment in Phase III for Terlipressin


Mallinckrodt plc MNK announced that it has completed enrolling patients in a late-stage study on its pipeline candidate, terlipressin, which is being developed for the treatment of Hepatorenal Syndrome type 1 (HRS 1).

The company achieved the enrollment target of 300 subjects in the ongoing phase III CONFIRM study, which will evaluate the safety and efficacy of the company’s investigational agent, terlipressin, for the given indication.

The phase CONFIRM III program is the largest prospective analysis to be ever conducted in patients suffering the HRS-1 syndrome. The primary endpoint (Verified HRS Reversal) of the probe is to examine the renal function improvement, avoidance of dialysis and short-term survival.

Currently, there are no treatments approved for HRS-1 in North America. Top-line data from the study is expected by this year-end. Mallinckrodt plans to file a new drug application (NDA) in early 2020, if results from this analysis are found to be supportive.

Notably, in 2016, Mallinckrodt reached an agreement with the FDA on the protocol design and data analysis of the CONFIRM study under the regulatory body’s special protocol assessment (SPA) process.

Shares of Mallinckrodt have lost 3% so far this year, outperforming the industry’s decline of 4.6%.

We would like to remind investors that last month, Stratatech, acquired by Mallinckrodt in 2016, completed enrollment in the phase III assessment of its investigational regenerative skin tissue, StrataGraft. The study is designed to evaluate the safety and efficacy of StrataGraft regenerative skin tissue for promoting autologous skin regeneration in patients with thermal burns that contain intact dermal elements (also known as deep partial-thickness burns).

Top-line findings from this evaluation are expected by this year-end. Mallinckrodt plans to file a Biologics License Application (BLA) in 2020, if outcomes from the program are found to be favorable.

Meanwhile, StrataGraft is also under phase II development for treating full thickness burns.

StrataGraft is a viable, engineered, bilayer human skin substitute, currently under development for severe burns and other complex skin defects.

Zacks Rank & Stocks to Consider

Mallinckrodt currently carries a Zacks Rank #3 (Hold). Better-ranked stocks from the healthcare sector include Merus N.V. MRUS, Gilead Sciences, Inc. GILD and Repligen Corporation RGEN, all flaunting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Merus’ loss per share estimates have been narrowed 28% for 2019 and 30.7% for 2020 over the past 60 days.

Gilead’s earnings estimates have moved 3.8% north for 2019 and 1.6% for 2020 over the past 60 days.

Repligen’s earnings estimates have been revised 13.2% upward for 2019 and 11% for 2020 over the past 60 days. The stock has inched up 0.4% year to date.

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