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Mallinckrodt plc (MNKPF) delivers innovative specialty pharmaceuticals addressing complex conditions like autoimmune disorders and rare diseases. This news hub provides investors and healthcare professionals with timely updates on the company's clinical advancements, regulatory milestones, and market strategies.
Access authoritative updates including quarterly earnings reports, product development announcements, and partnership disclosures. Our curated collection features press releases on FDA approvals, research publications in peer-reviewed journals, and strategic initiatives across both Specialty Brands (targeted therapies) and Specialty Generics (essential medicines).
Stay informed about Mallinckrodt's evidence-based approach to drug development, including real-world outcome studies and manufacturing innovations. This resource serves analysts tracking pharmaceutical sector trends and investors monitoring the company's response to evolving healthcare markets.
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Mallinckrodt announced data on TERLIVAZ® (terlipressin) at the 2024 European Association for the Study of the Liver (EASL) Congress. Three posters were presented, focusing on outcomes in patients with hepatorenal syndrome (HRS) and rapid kidney function decline.
Key findings include potential benefits of early diagnosis and treatment with TERLIVAZ, resulting in 3,040 more HRS reversals, 960 fewer needing renal replacement therapy, and significant healthcare cost savings. Data also showed improved survival rates in patients with lower baseline mean arterial pressure and better renal function among those with alcohol-associated hepatitis and acute-on-chronic liver failure grades 0–2.
However, the FDA has not evaluated the safety and efficacy of TERLIVAZ within these subgroups. Limitations include small sample sizes and potential methodological errors. TERLIVAZ remains the only FDA-approved treatment for adults with HRS with rapid kidney function decline, but it poses serious respiratory risks, particularly in specific patient groups.
Mallinckrodt plc reported first quarter 2024 financial results with net sales of $467.8 million, showing 10.2% year-over-year growth. The company achieved a net loss of $65.4 million, reflecting a 73.8% improvement, and delivered adjusted EBITDA of $144.9 million, up by 17.3% year-over-year. Mallinckrodt also initiated the rollout of INOmax EVOLVE DS Delivery System and anticipates the launch of Acthar Gel SelfJect Injector in the third quarter of 2024.
Mallinckrodt reported a fourth-quarter net loss of $249.5 million, with net sales declining to $489.3 million, an 18.1% year-over-year decrease. The Specialty Brands segment saw a 19.3% drop in sales, while the Specialty Generics segment decreased by 15.6%. Despite challenges, including competition and a loss of revenue from Amitiza and Acthar Gel, the company enhanced its cash position to $409.5 million. Looking forward to 2023, Mallinckrodt anticipates total net sales between $1.700 billion and $1.820 billion, aiming for adjusted EBITDA of $510 million to $560 million. Key initiatives include the launch of Terlivaz and the appointment of a new Chief Scientific Officer.
Mallinckrodt plc (AMEX:MNK) announced that Siggi Olafsson, President and CEO, will present at Cowen's 43rd Annual Health Care Conference in Boston, MA, on March 7, 2023, at 2:50 p.m. Eastern Time. For those unable to attend in person, a webcast will be available, with a replay accessible after the event. Mallinckrodt, a global specialty pharmaceuticals company, focuses on areas such as autoimmune and rare diseases, including neurology and oncology. More details can be found on their website.
Mallinckrodt (NYSE American: MNK) announced the presentation of seven scientific abstracts on TERLIVAZ® (terlipressin) at the AASLD 2022 Liver Meeting, highlighting treatment outcomes for hepatorenal syndrome (HRS). The studies, showcasing clinical and economic outcomes, emphasize the company’s commitment to improving care for HRS patients. Notably, TERLIVAZ is the first FDA-approved therapy for HRS, significantly impacting kidney function. The meeting takes place in Washington, DC from November 4-8, 2022, presenting key findings that underline the urgent needs of HRS patients.
Mallinckrodt (OTCMKTS: MNKPF) announced five scientific abstracts on TERLIVAZ (terlipressin) for patients with hepatorenal syndrome (HRS) will be presented at the American College of Gastroenterology Annual Scientific Meeting in Charlotte, NC, from October 21-26, 2022. TERLIVAZ is the first FDA-approved treatment aimed at improving kidney function in adults with HRS involving rapid kidney function reduction. The studies show the clinical and economic burden HRS patients face and the potential benefits of terlipressin in addressing these challenges.
Mallinckrodt plc has received approval to list its ordinary shares on NYSE American, with trading expected to commence under the ticker symbol MNK on October 27, 2022. This listing is part of the company's strategy to drive growth and enhance shareholder value. The President and CEO, Siggi Olafsson, emphasized the significance of this move in advancing therapies for underserved patients. The company will cease trading on the OTC Pink Current Market simultaneously with the NYSE American listing.
Mallinckrodt plc (OTCMKTS: MNKPF) has announced the date for its third quarter 2022 earnings release, scheduled for November 8, 2022. This report covers the financial performance for the period ending September 30, 2022. A conference call for investors will follow the earnings report, starting at 8:30 a.m. ET. The call will be accessible via live registration and an audio-only webcast. Mallinckrodt specializes in pharmaceuticals, focusing on areas such as autoimmune and rare diseases.
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