Mallinckrodt plc - MNKTQ STOCK NEWS

Mallinckrodt plc announced the presentation of findings from a post hoc analysis of the Phase 3 CONFIRM clinical trial, showing the therapeutic effect of TERLIVAZ in adult patients with hepatorenal syndrome and alcoholic hepatitis. The analysis found that the incidence of verified HRS reversal was significantly higher in patients treated with TERLIVAZ vs. placebo.

Mallinckrodt plc (MNK) emerges from Chapter 11 with a strengthened balance sheet and increased financial flexibility. Recent progress includes net sales and adjusted EBITDA growth, FDA acceptance of Acthar® Gel delivery device, positive momentum for Terlivaz®, and growth for Therakos®. The Specialty Generics segment benefits from vertical integration and U.S.-based manufacturing plants, with three FDA abbreviated new drug application approvals. The company reduced its total funded debt by approximately $1.9 billion and satisfied obligations to the Opioid Master Disbursement Trust II.

Mallinckrodt plc (OTCMKTS: MNKTQ) announced 11 scientific abstracts at the AASLD 2023 Liver Meeting, presenting findings from clinical and health economics research with TERLIVAZ (terlipressin) for injection for adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function. The research details the clinical efficacy, safety, and real-world utility of TERLIVAZ, the first and only FDA-approved product to improve kidney function in adults with HRS with rapid reduction in kidney function.

Mallinckrodt plc reported a 6.8% increase in net sales for the third quarter of 2023, reaching $497.0 million. The company's financial restructuring plan was approved by the U.S. Bankruptcy Court, positioning it to complete the Irish Examinership and emerge from Chapter 11 in the near term. The company's Specialty Generics segment experienced a 30.2% increase in net sales, while the Specialty Brands segment reported a 5.7% decrease. Adjusted EBITDA for the third quarter was $180.6 million, an 8.7% increase compared to the prior year quarter.

Mallinckrodt plc announced that three scientific abstracts evaluating treatment with TERLIVAZ for adults with hepatorenal syndrome (HRS) will be presented at the American Society of Nephrology Kidney Week 2023 Scientific Meeting. TERLIVAZ is the first FDA-approved product indicated to improve kidney function in adults with HRS. The abstracts will explore the impact of TERLIVAZ on patient care, key HRS endpoints, patient comorbidity, and the role of TERLIVAZ in HRS reversal. The studies are sponsored by Mallinckrodt Pharmaceuticals.

Mallinckrodt plc shared findings from health economics research on Acthar Gel for patients with advanced symptomatic sarcoidosis and nephrotic syndrome. The cost-effectiveness analysis showed that Acthar Gel resulted in an incremental cost-effectiveness ratio (ICER) of $134,796 per quality-adjusted life-year (QALY) and $39,179 per QALY over two and three years, respectively. From a societal perspective, Acthar versus standard of care resulted in an ICER of $117,622 per QALY over two years and $21,967 per QALY over three years.

Mallinckrodt presents findings from clinical studies and health economic analysis of TERLIVAZ for hepatorenal syndrome treatment outcomes at ACG Annual Scientific Meeting

Mallinckrodt's Plan of Reorganization confirmed by U.S. Bankruptcy Court, positioning the Company to emerge from Chapter 11 by year-end.

Mallinckrodt publishes two journal manuscripts supporting Acthar Gel's efficacy and economic benefits in autoimmune and inflammatory diseases