Welcome to our dedicated page for Mallinckrodt news (Ticker: MNKKQ), a resource for investors and traders seeking the latest updates and insights on Mallinckrodt 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.
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.
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 results from a Phase 4 study assessing Acthar Gel for treatment-resistant severe non-infectious keratitis. Data presented at the ARVO Annual Meeting showed that 50% of 36 patients improved significantly after 12 weeks of treatment, as measured by the IDEEL score. Safety assessments revealed that 33.3% experienced treatment-emergent adverse events (TEAEs), primarily hypertension. Acthar Gel is FDA-approved for severe ocular inflammation, highlighting its potential for patients needing alternative therapies.
Mallinckrodt plc (OTCMKTS: MNKKQ) announced data from a Phase 4 observational registry at the PAS 2021 Virtual Meeting, evaluating INOmax® (nitric oxide) in term and preterm neonates with pulmonary hypertension. The study involved 140 neonates, showing 90.9% of preterm and 88.2% of term neonates achieved a ≥25% improvement in oxygenation during treatment. The registry aims to expand understanding of INOmax's role in this vulnerable population. Notably, all adverse events reported were serious but none were attributed to the treatment.
Mallinckrodt plc (OTCMKTS: MNKKQ) announced its Specialty Generics division received Manufacturing Leadership Awards for Collaborative Innovation and Operational Excellence from the National Association of Manufacturers. Their COVID-19 Response Team was recognized for ensuring uninterrupted drug supply and manufacturing safety during the pandemic. The Hobart, NY facility was honored for a successful Packaging Process Improvement Project, which resulted in reduced maintenance time and enhanced productivity. These awards highlight Mallinckrodt's commitment to being a reliable US-based supplier of essential medicines.
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 announced the publication of pivotal Phase 3 CONFIRM study results for terlipressin, an investigational treatment for hepatorenal syndrome type 1 (HRS-1), in the New England Journal of Medicine. The study met its primary endpoint of Verified HRS Reversal, demonstrating renal function improvement and avoidance of dialysis. Terlipressin showed lower rates of renal replacement therapy compared to the placebo group, although one secondary endpoint did not reach statistical significance. The company is exploring potential regulatory pathways following previous FDA discussions regarding its New Drug Application.
Mallinckrodt announced that the FDA is deferring action on its Biologics License Application for StrataGraft due to COVID-19-related travel restrictions affecting a required site inspection. Despite this delay, the company expressed confidence in StrataGraft's efficacy based on Phase 3 clinical trial results. The BLA received priority review and has orphan drug and RMAT designations. StrataGraft is designed to treat deep partial-thickness burns with the aim of reducing the need for autografting. The continued development is supported by BARDA under Project BioShield.