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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.
Mallinckrodt plc (OTCMKTS: MNKKQ) announced on July 1, 2021, that the European Respiratory Society (ERS) has included Acthar Gel in its new treatment guidelines for pulmonary sarcoidosis. This marks a significant recognition as it is the first ERS-issued clinical practice recommendation that supports the use of Acthar Gel for managing certain patients with the disease. The guidelines highlight its steroid-sparing potential and align with previous recommendations by the U.S. Sarcoidosis Expert Panel. Mallinckrodt continues to invest in research to better understand Acthar Gel's mechanisms of action.