Welcome to our dedicated page for MNK news (Ticker: MNK), a resource for investors and traders seeking the latest updates and insights on MNK stock.
The MNK news page on Stock Titan aggregates company-issued updates and media coverage related to Mallinckrodt plc and its subsequent branded therapeutics identity, Keenova Therapeutics. Recent press releases describe Mallinckrodt as a global specialty pharmaceutical company with a Brands business focused on autoimmune and rare diseases and a Par Health business that includes generic drugs, sterile injectables and active pharmaceutical ingredients.
News items for MNK include announcements on corporate transactions, such as the completion of the merger between Mallinckrodt and Endo, Inc., and the spin-off of the combined generics and sterile injectables businesses under the Par Health name. These releases also explain that, moving ahead, Mallinckrodt will be known as Keenova Therapeutics, a branded therapeutics company focused on helping patients with rare or unaddressed conditions.
Investors and followers of MNK can find updates on financial results, including quarterly net sales and segment performance for Specialty Brands, Generics and Sterile Injectables as reported by the company. Other news covers developments in key branded products, such as Acthar Gel and XIAFLEX, as well as communications about clinical and medical affairs activities, including data presentations related to TERLIVAZ for hepatorenal syndrome.
Additional coverage includes leadership and governance announcements, such as board appointments and executive changes, along with guidance and commentary on the company’s strategy around its Brands and Par Health businesses. For users tracking MNK, this news feed provides a central view of the company’s own disclosures on its therapeutic focus, portfolio evolution, corporate structure and branded transition to Keenova Therapeutics.
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.
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.
