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Mallinckrodt Gets CRL From FDA for Terlipressin, Shares Fall

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Shares of Mallinckrodt plc  were down 8.3% after it announced that the FDA has issued a Complete Response Letter (CRL) for its new drug application (NDA) seeking approval for the investigational agent terlipressin, to treat adults with hepatorenal syndrome type 1 (HRS-1). HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis. However, shares of the company have slumped 68.5% year to date compared with the industry’s decline of 10.3%.

The CRL stated that it required more information in support of a positive risk-benefit profile for terlipressinin patients with HRS-1.

Terlipressin is a vasopressin analog selective for V1 receptors.It is an investigational agent being evaluated for the treatment of HRS-1 in the United States.In July, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8 to 7 in favor of the approval of terlipressin for HRS-1 based on data from the pivotal phase III CONFIRM study. Results showed that terlipression met the primary and key secondary endpoints demonstrating HRS reversal. 

The company stated that it will work with the FDA and pursue all available options to get the drug to the U.S. market. The company remains confident about the strength of the data from the CONFIRM study, which was the largest-ever prospective study (n=300) conducted to assess the safety and efficacy of terlipressin in patients with HRS-1 for potential use in the United States and Canada.

Zacks Rank &Stocks to Consider

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

Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. (EBS - Free Report) , Bio Techne Corp (TECH - Free Report) and Alimera Sciences Inc. (ALIM - Free Report) . While Emergent sports a Zacks Rank #1 (Strong Buy), Bio Techne and Alimera carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings estimates have increased from $4.03 to $6.07 for 2020 and from $5.07 to $6.17 for 2021 over the past 60 days. Shares of the company have increased 93.1% year to date.

Bio Techne’s earnings estimates have increased from $5.33 to $5.48 for 2020 and from $6.41 to $6.50 for 2021 over the past 60 days. Shares of the company have increased 12.7% year to date.

Alimera’s loss per share estimates have narrowed from $2.33 to $1.31 for 2020 and from 63 cents to 52 cents for 2021 over the past 60 days. Shares of the company have decreased 54% year to date.


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