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Mallinckrodt plc (MNK) delivers specialty pharmaceutical solutions and medical imaging innovations across autoimmune, rare disease, and diagnostic markets. This news hub provides investors and healthcare professionals with essential updates on the company’s strategic developments and regulatory milestones.
Access timely reports on earnings announcements, product approvals, research advancements, and partnership agreements. Our curated collection features official press releases alongside verified third-party coverage of MNK’s activities in specialty generics, contrast media production, and therapeutic pipeline progress.
Key content categories include financial performance updates, manufacturing capacity expansions, intellectual property developments, and compliance-related communications. Track MNK’s progress in neurology, rheumatology, and nephrology treatment innovations through objective reporting of material events.
Bookmark this page for streamlined monitoring of Mallinckrodt’s operational updates and market positioning. Check back regularly for authoritative coverage of this specialty pharma leader’s initiatives in addressing complex healthcare challenges through advanced biopharmaceutical solutions.
Mallinckrodt (OTCMKTS: MNKPF) announced the FDA approval of Terlivaz (terlipressin), the first and only treatment for adults with hepatorenal syndrome (HRS) involving rapid kidney function reduction. This significant milestone brings a much-needed therapeutic option for critically ill patients requiring hospitalization. The approval is supported by the Phase 3 CONFIRM trial results, which demonstrated terlipressin's efficacy in improving kidney function and avoiding dialysis. Terlivaz is expected to launch in the U.S. soon, aiming to address a condition affecting 30,000-40,000 Americans annually.
Mallinckrodt plc (OTCMKTS: MNKPF) announced the presentation of two scientific posters on hepatorenal syndrome (HRS) at the 2022 International Liver Congress in London. These studies focus on the effects of terlipressin, an investigational treatment for rapid kidney function decline associated with HRS. The research highlights early treatment benefits and explores gender differences in clinical responses. Mallinckrodt aims to enhance understanding of HRS management, crucial for approximately 30,000 to 40,000 Americans annually, with a grim prognosis if untreated.
Mallinckrodt plc (OTCMKTS: MNKKQ) announced findings from a retrospective study on Acthar Gel for refractory rheumatoid arthritis (RA), published in Drugs in Context. The study analyzed medical records of 63 patients and found that Acthar Gel treatment resulted in improved clinical outcomes, reduced concomitant medication prescriptions, and a significant decrease in the Clinical Disease Activity Index (CDAI) score. Most patients were on the recommended dosage for an average of 10.3 months. The results indicate the potential effectiveness of Acthar Gel for patients with high RA disease activity.
Mallinckrodt plc (OTCMKTS: MNKKQ) announced FDA approval for StrataGraft®, an allogeneic product for treating adults with deep partial-thickness burns requiring surgical intervention. This therapy aims to reduce autografting needs, addressing complications like pain and infection. Funded partly by $86 million from BARDA, StrataGraft's pivotal Phase 3 trial showed a 96% success rate in avoiding autografting. This approval represents a significant advancement in burn care, with plans for future studies in pediatric populations and full-thickness burns.
Mallinckrodt plc (OTCMKTS: MNKKQ) announced a restructuring support agreement with an ad hoc group holding approximately $1.3 billion of its first lien term loans. This agreement aims to resolve disputes between the company and lenders while extending debt maturities. The restructuring plan includes provisions such as an increase in LIBOR margin and a maturity extension until September 30, 2027. The company previously filed for Chapter 11 to handle opioid-related claims, with the restructuring expected to strengthen its financial position and reduce total debt.
Mallinckrodt plc (OTCMKTS: MNKKQ) has successfully reached an agreement with an ad hoc group of first lien term lenders holding approximately $1.3 billion of its outstanding loans to support its restructuring efforts. This agreement aims to replace existing loans and mitigate disputes related to the restructuring plan, effectively extending debt maturities. Furthermore, the restructuring plan targets an overall reduction in debt by roughly $1.3 billion to enhance the company's financial position and facilitate ongoing investments in new therapies and patient care.
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.
