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FDA Advisory Committee to Review Mallinckrodt'sTerlipressin

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Mallinckrodt plc  announced that the Cardiovascular and Renal Drugs Advisory Committee of the FDA will hold a virtual meeting to review data on terlipressin. Terlipressin is an investigational agent being evaluated for the treatment of 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.

The company submitted a new drug application (NDA) to the FDA for terlipressin. The NDA was partly based on positive top-line results from its phase III CONFIRM study evaluating the efficacy and safety of terlipressin in 300 adults with HRS-1. The study met its primary endpoint of verified HRS-1 reversal. The FDA accepted the NDA for review in April 2020.

Shares of Mallinckrodt have lost 30.1% so far this year compared with the industry’s decline of 7.6%.

Currently, there are no approved drug therapies for HRS-1 in the United States and it is estimated to affect 30,000-40,000 patients in the United States annually.

Mallinckrodt is striving hard to diversify its portfolio. The company,in June, also 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. 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.


Zacks Rank & Stocks to Consider

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

Better-ranked stocks in the healthcare sector include Acasti Pharma, Inc. , Personalis Inc. (PSNL - Free Report) and TEVA Pharmaceutical Industries Ltd. (TEVA - Free Report) , all carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Acasti’s loss per share estimates have narrowed from 41 cents to 37 cents for 2020 and from 34 cents to 28 cents for 2021 in the past 60 days.

Personalis’ loss per share estimates have narrowed from $1.22 to $1.21 for 2020 over the past 60 days.

TEVA’s earnings per share estimates have increased from $2.43 to $2.48 for 2020 over the past 60 days.

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