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FDA Advisory Committee Recommends Mallinckrodt's Trelipressin

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Mallinckrodt plc announced that the Cardiovascular and Renal Drugs Advisory Committee of the FDA voted  in favor of approval of its investigational candidate, terlipressin, to treat adults with hepatorenal syndrome type 1 (HRS-1). There were eight votes in favor while seven were not in favor of the approval.

While the FDA is not bound to follow the recommendations of the advisory committee, the agency will consider the recommendation as part of the new drug application review. The FDA assigned terlipressin an action date of Sep 12, 2020.

Shares of the company have lost 11.2% year to date compared with the industry’s decline of 3.0%.

Terlipressin is an investigational agent being evaluated for the treatment of HRS-1 in the United States and its safety and effectiveness have not yet been established by the FDA.

Terlipressin is not approved for any indication in the United States and Canada yet. A potential approval of the candidate in the United States will be a huge boost for the company. 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 country annually. HRS-1 can lead to life-threatening kidney failure within days and can only be cured with a liver transplant, which addresses the liver disease and its effects on kidney function.

The company submitted a new drug application (NDA) to the FDA for terlipressin in March 2020. 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.Mallinckrodt stated that the FDA Advisory Committee meeting will hold a meeting to discuss the submission.

Mallinckrodt is striving hard to diversify its portfolio. Last month, the company 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 Emergent Biosolutions Inc. (EBS - Free Report) , Acasti Pharma, Inc. and Personalis Inc. (PSNL - Free Report) . While Emergent sports a Zacks Rank #1 (Strong Buy), Acasti and Personalis carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings per share estimates have increased from $3.18 to $4.03 for 2020 and from $3.32 to $4.31 for 2021 in the past 60 days.

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.


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