Mallinckrodt plc - MNK STOCK NEWS

Mallinckrodt plc announced results from post-hoc studies of its investigational agent terlipressin for adults with hepatorenal syndrome type 1 (HRS-1). Presented at Kidney Week 2020, the analysis included data from three Phase 3 trials, showing that terlipressin significantly reduced the need for renal replacement therapy (RRT) compared to placebo. At Day 90, 29% of terlipressin patients needed RRT, compared to 45% on placebo. Additionally, RRT-free survival was higher in terlipressin patients at 90 days (37% vs. 29%). Terlipressin's safety and efficacy are still pending FDA approval.

Mallinckrodt has voluntarily initiated Chapter 11 bankruptcy proceedings in the U.S. to restructure its $1.3 billion debt and resolve overwhelming legal liabilities, particularly related to opioid claims. The company, along with its subsidiaries, will continue normal operations while implementing a restructuring support agreement (RSA) that aims to enhance its financial position and foster long-term growth. The RSA includes key stakeholders, and the company plans to address opioid claim settlements through a structured payment trust totaling $1.6 billion.

Mallinckrodt plc (NYSE: MNK) announced that the FDA issued a Complete Response Letter (CRL) for its New Drug Application (NDA) of terlipressin, intended to treat hepatorenal syndrome type 1 (HRS-1). The FDA stated that more data is needed to demonstrate a positive risk-benefit profile for terlipressin, which currently lacks FDA approval despite being used as standard care in other countries. HRS-1 affects 30,000 to 40,000 Americans annually, with a high mortality rate if untreated. Mallinckrodt remains committed to pursuing FDA approval, despite expressing disappointment with the CRL's issuance.

Mallinckrodt Pharmaceuticals (NYSE: MNK) announced its Specialty Generics business received two Manufacturing Leadership Awards from the National Association of Manufacturers. The Hobart, N.Y. manufacturing site won awards in Operational Excellence Leadership for a packaging changeover project that cut time by 50%, and in Engineering and Production Technology Leadership for exceeding FDA serialization requirements. This is the third consecutive year of recognition, underscoring the company's commitment to quality manufacturing solutions.

Mallinckrodt plc (NYSE: MNK) announced that the FDA accepted the Biologics License Application for StrataGraft skin tissue, an investigational therapy for adults with deep partial-thickness thermal burns. The FDA granted priority review, setting a PDUFA target date of February 2, 2021. The therapy aims to reduce the need for autografting, which is currently the standard care. Approximately 40,000 patients in the U.S. are hospitalized annually for severe burns. The development is supported by BARDA as part of a public health initiative.

In Q2 2020, Mallinckrodt reported net sales of $166.5 million and adjusted net sales of $700.9 million, a 14.9% decline primarily due to COVID-19 impacts and competitive pressures. The diluted loss per share stood at $11.04, while adjusted diluted EPS was $1.89, down 25.3%. The company reported cash flow from operations of $170.9 million and free cash flow of $159.5 million. Additionally, they face potential Chapter 11 reorganization due to ongoing opioid litigation and high debt levels. Despite challenges, pipeline advancements include FDA advisory committee support for terlipressin.

Mallinckrodt plc (NYSE: MNK) announced that the FDA's Cardiovascular and Renal Drugs Advisory Committee voted 8 to 7 in favor of recommending approval for terlipressin to treat hepatorenal syndrome type 1 (HRS-1), a severe condition linked to acute kidney failure in cirrhosis patients. There are currently no approved therapies for HRS-1 in the U.S., affecting 30,000 to 40,000 Americans annually. The FDA has set a PDUFA target date of September 12, 2020, for the New Drug Application review, following promising results from the Phase 3 CONFIRM trial.

Mallinckrodt (NYSE: MNK) is set to announce its second quarter 2020 earnings results on August 4, 2020, for the period ending June 26, 2020.

The conference call for investors will begin at 8:30 a.m. Eastern Time, with access available through their website, telephone, or audio replay. Investors can expect insights into the company's performance in areas like autoimmune and rare diseases, as well as specialty pharmaceuticals.

Mallinckrodt plc (NYSE: MNK) announced that the FDA's Cardiovascular and Renal Drugs Advisory Committee will hold a virtual meeting to review its New Drug Application (NDA) for terlipressin. This investigational drug targets hepatorenal syndrome type 1 (HRS-1), a severe condition with high mortality rates and no approved therapies in the U.S. The NDA is supported by data from the Phase 3 CONFIRM trial, the largest study of its kind for HRS-1, involving 300 patients. If approved, terlipressin could meet a critical medical need for approximately 30,000 to 40,000 annual patients in the U.S.