Welcome to our dedicated page for Mallinckrodt Plc news (Ticker: MNKKQ), a resource for investors and traders seeking the latest updates and insights on Mallinckrodt Plc stock.
The news and updates associated with Mallinckrodt plc (historically MNKKQ) reflect its role as a global specialty pharmaceutical company with activities across branded and generic therapies. Company press releases highlight developments in its two reportable segments, Specialty Brands and Specialty Generics, as well as corporate and financial milestones.
On the product and clinical side, Mallinckrodt’s news flow has included regulatory updates and research findings. Examples described by the company include resubmission of a New Drug Application to the U.S. Food and Drug Administration for the investigational agent terlipressin in hepatorenal syndrome, retrospective real-world studies of Acthar Gel in symptomatic sarcoidosis and refractory rheumatoid arthritis, and analyses of the investigational use of INOmax (nitric oxide) gas for inhalation in hospitalized COVID-19 patients with mild-to-moderate acute respiratory distress syndrome. These communications often summarize study designs, key outcomes and limitations, and emphasize that certain uses remain investigational.
Mallinckrodt’s news releases have also detailed significant corporate events. The company has reported confirmation of its Plan of Reorganization by the U.S. Bankruptcy Court for the District of Delaware, confirmation of a related scheme of arrangement by the High Court of Ireland, and subsequent emergence from Chapter 11 and completion of Irish Examinership proceedings. Related announcements describe the cancellation of existing ordinary shares, issuance of new ordinary shares and warrants to creditors and claimants, and new financing arrangements.
Investors following MNKKQ-related news can therefore expect coverage of clinical and real-world evidence publications, regulatory correspondence and milestones for specialty therapies, as well as restructuring developments and capital structure changes. For ongoing updates, Mallinckrodt has indicated that it uses its corporate website as a channel for distributing press releases, investor presentations and other financial information.
Summary not available.
Mallinckrodt plc (OTCMKTS:MNKKQ) announced the enrollment of the first patient in the StrataSOMA clinical trial for StrataGraft, a treatment for adult patients with third-degree full-thickness thermal burns. This Phase 1/2a trial aims to evaluate the efficacy and safety of StrataGraft, following its FDA approval in June 2021 for deep partial-thickness burns. The trial will enroll 40 adults and assesses primary outcomes such as complete wound closure without additional autografting at two months. StrataGraft is designed to improve healing while minimizing donor site wounds.
Mallinckrodt plc (OTCMKTS: MNKKQ) announced a retrospective study on the effectiveness of extracorporeal photopheresis (ECP) for cutaneous T-cell lymphoma (CTCL), presented at the American Society for Hematology meeting. The study involved 52 patients treated between January 2017 and February 2019. Results indicated that 36.5% experienced over a 50% reduction in affected skin areas within 6.5 months. However, limitations include reliance on real-world medical charts and the potential influence of concomitant therapies. The study emphasizes the need for further data on ECP treatment outcomes.
The Buxton Helmsley Group, Inc. has issued an open letter regarding the resignation of Mallinckrodt's Chief Communications Officer, Brandi Robinson. This follows the recent departure of Senior Vice President of Finance, Kathy Schaefer, who resigned on November 3, 2021, after an October 26 letter disclosed multiple instances of alleged fraud within the company, including accounting and insider trading violations. BHG's correspondence aims to address these significant governance concerns impacting shareholders of Mallinckrodt (MNKKQ).
Mallinckrodt plc (OTCMKTS: MNKKQ) announced findings from two studies on hepatorenal syndrome type-1 (HRS-1) at the Liver Meeting Digital Experience. The first study, involving 132 patients, showed low overall response rates to current treatment regimens, highlighting a significant unmet medical need. The second study analyzed 203 patients treated with terlipressin, showing that those with higher serum creatinine levels had poorer outcomes. Terlipressin remains investigational in the U.S. and Canada, with no FDA approval yet.
The Buxton Helmsley Group (BHG) has issued an open letter regarding the recent resignation of Mallinckrodt Plc's Senior Vice President of Finance, Kathy Schaefer. This resignation comes shortly after BHG highlighted serious allegations against the company’s management, including various forms of fraud. BHG represents clients with substantial investments in Mallinckrodt and seeks accountability from its board of directors. The complete letter can be accessed through BHG's dedicated website.
The Buxton Helmsley Group, Inc. has issued an open letter to the U.S. Securities and Exchange Commission (SEC) regarding serious allegations against Mallinckrodt Plc (MNKKQ). The letter accuses the company of fraudulent financial statements, bankruptcy fraud, insider trading, proxy fraud, and electoral fraud. BHG represents significant shareholders in this effort for SEC intervention to protect investors from potential manipulative practices. The full letter can be accessed online for further details.
Mallinckrodt plc (OTCMKTS: MNKKQ) presented findings from a retrospective medical chart review study on terlipressin for treating esophageal variceal hemorrhage (EVH) at the American College of Gastroenterology Annual Scientific Meeting. The study analyzed 195 patients in the U.K. from January 2016 to September 2019, revealing that 59.5% achieved initial bleed control within 36 hours. Despite its potential, terlipressin's safety and efficacy are still under investigation by the FDA. The company remains committed to researching therapies for cirrhosis complications.
Mallinckrodt plc (MNKKQ) announced reaching an agreement with the Official Committee of Opioid Related Creditors and others to support an amended Plan of Reorganization amid ongoing Chapter 11 proceedings. The new plan aims to reduce debt by approximately $1.3 billion and address numerous litigation claims, particularly relating to opioids. The agreement has garnered significant support, including from holders of 84% of the Company’s unsecured notes and various state litigators. A confirmation hearing is set for September 2021, with potential completion of the reorganization in 90-150 days.
Mallinckrodt plc (OTCMKTS: MNKKQ) announced the publication of results from its pivotal Phase 3 STRATA2016 clinical trial for StrataGraft®, a treatment for deep partial-thickness burns. The trial demonstrated that 96% of burn sites treated with StrataGraft did not require autografting, with 83.1% achieving durable wound closure by three months. Published in the peer-reviewed journal Burns, these results indicate significant potential for StrataGraft as a less invasive burn treatment alternative. Supported by BARDA, the study aims to address the need for improved burn care options.