CRL for Mallinckrodt's terlipressin in HRS-1 sends shares lower

14 September 2020

Shares of Ireland-headquartered drugmaker Mallinckrodt (NYSE: MNK) were down 11.6% at $1.06 by mid-morning today, after it announced that the US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the company's New Drug Application (NDA) seeking approval for the investigational agent terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1).

The CRL stated that, based on the available data, the agency cannot approve the terlipressin NDA in its current form and requires more information to support a positive risk-benefit profile for terlipressin for patients with HRS-1, a life-threatening syndrome involving acute kidney failure in people with cirrhosis.

This adds a further setback for the company which has been implicated in the US opioid crisis and is $5.3 billion in debt. In February this year, Mallinckrodt announced an agreement in principle on the terms of a global settlement that would resolve all opioid-related claims against Mallinckrodt, with a $1.6 billion settlement

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