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Mallinckrodt plc - MNK STOCK NEWS

Welcome to our dedicated page for Mallinckrodt plc news (Ticker: MNK), a resource for investors and traders seeking the latest updates and insights on Mallinckrodt plc stock.

Mallinckrodt plc (MNK) is a global specialty biopharmaceutical and medical imaging company. Headquartered in Dublin, the company is renowned for developing, manufacturing, marketing, and distributing specialty pharmaceutical products and medical imaging agents. Its diverse portfolio spans therapeutic drugs for autoimmune and rare diseases in specialty areas such as neurology, rheumatology, nephrology, ophthalmology, and pulmonology. The company also focuses on immunotherapy, neonatal respiratory critical care therapies, analgesics, and central nervous system drugs.

The company's Specialty Brands segment features a range of branded medicines, while the Specialty Generics segment includes generic drugs and active pharmaceutical ingredients. The Global Medical Imaging segment provides contrast media and nuclear imaging agents. Mallinckrodt's expertise lies in the acquisition and management of highly regulated raw materials, regulatory know-how, and specialized chemistry, formulation, and manufacturing capabilities.

Recent achievements include findings from health economics outcomes research on Acthar® Gel, which were shared at the Academy of Managed Care Pharmacy Nexus 2023. Acthar Gel, approved by the FDA for treating various autoimmune disorders and inflammatory conditions, demonstrated cost-effectiveness for patients with advanced symptomatic sarcoidosis and nephrotic syndrome. Additionally, the company presented new data on TERLIVAZ® at the Society of Critical Care Medicine 2024 Critical Care Congress, showing its efficacy in improving kidney function in adults with hepatorenal syndrome.

Mallinckrodt is committed to continuous innovation, evidenced by the FDA's approval of the Acthar Gel Single-Dose Pre-filled SelfJect™ Injector, designed to provide patients with better control over their medication administration. Financially, Mallinckrodt reported a net sales increase to $467.8 million in Q1 2024, driven by growth in both its Specialty Brands and Specialty Generics segments.

News

Mallinckrodt Announces U.S. FDA Approval of Supplemental New Drug Application for Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector

Rhea-AI Summary
Mallinckrodt plc receives FDA approval for Acthar Gel Single-Dose Pre-filled SelfJect Injector, a new delivery device for patients with inflammatory and autoimmune conditions. The device aims to simplify Acthar Gel administration, enhancing patient control. The product is set to launch in the U.S. in the second half of 2024.
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Mallinckrodt Announces Board of Directors and Leadership Updates

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Mallinckrodt plc announced the addition of four seasoned professionals to its Board of Directors, including Paul Bisaro as Board Chair. Siggi Olafsson will continue as President, CEO, and Board Member. The company aims to strengthen its leadership team and continue to deliver for its patients and public health needs.
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Mallinckrodt Presents New Data on TERLIVAZ® (terlipressin) for Injection at the Society of Critical Care Medicine (SCCM) 2024 Critical Care Congress

Rhea-AI Summary
Mallinckrodt plc announced the presentation of findings from a post hoc analysis of the Phase 3 CONFIRM clinical trial, showing the therapeutic effect of TERLIVAZ in adult patients with hepatorenal syndrome and alcoholic hepatitis. The analysis found that the incidence of verified HRS reversal was significantly higher in patients treated with TERLIVAZ vs. placebo.
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Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American Society of Nephrology (ASN) Kidney Week 2023 Scientific Meeting

Rhea-AI Summary
Mallinckrodt plc announced that three scientific abstracts evaluating treatment with TERLIVAZ for adults with hepatorenal syndrome (HRS) will be presented at the American Society of Nephrology Kidney Week 2023 Scientific Meeting. TERLIVAZ is the first FDA-approved product indicated to improve kidney function in adults with HRS. The abstracts will explore the impact of TERLIVAZ on patient care, key HRS endpoints, patient comorbidity, and the role of TERLIVAZ in HRS reversal. The studies are sponsored by Mallinckrodt Pharmaceuticals.
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Mallinckrodt Presents Latest Health Economics Data on Acthar® Gel (Repository Corticotropin Injection) at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023

Rhea-AI Summary
Mallinckrodt plc shared findings from health economics research on Acthar Gel for patients with advanced symptomatic sarcoidosis and nephrotic syndrome. The cost-effectiveness analysis showed that Acthar Gel resulted in an incremental cost-effectiveness ratio (ICER) of $134,796 per quality-adjusted life-year (QALY) and $39,179 per QALY over two and three years, respectively. From a societal perspective, Acthar versus standard of care resulted in an ICER of $117,622 per QALY over two years and $21,967 per QALY over three years.
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Buxton Helmsley Issues Statement on Mallinckrodt plc. Bankruptcy Filing and Disclosures Revealing Apparently Concealed Intangible Asset Depreciation Expenses

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Mallinckrodt Plc. files for Chapter 11 bankruptcy protection, revealing nearly $1 billion in intangible asset depreciation expenses that were allegedly concealed. Current shareholders are set to receive no recovery as their equity interests will be wiped out. Company's insiders remain silent on allegations of accounting and securities fraud. BHG's allegations may have been vindicated.
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Mallinckrodt Receives Court Approval for "First Day" Motions to Support Ongoing Operations

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Mallinckrodt receives approvals for Chapter 11 petitions, enabling normal operations and payment of vendors and suppliers. Restructuring plan to reduce total funded debt by $1.9 billion.
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Mallinckrodt plc Takes Next Step to Implement Comprehensive Financial Restructuring Plan to Address Long-Term Debt and Opioid Obligations

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Mallinckrodt initiates voluntary prepackaged Chapter 11 proceedings with overwhelming support of key stakeholders, including 85%+ of debtholders. Expects to reduce total funded debt by $1.9 billion and increase free cash flow generation. Continues to operate normally, serve customers, and deliver therapies to patients. Vendors and suppliers expected to be paid in full. Court approval expected for continued operations and payment of employee wages and benefits.
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Mallinckrodt plc Enters into Restructuring Support Agreement with Key Stakeholders on the Terms of a Prepackaged Financial Restructuring Plan

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Mallinckrodt announces Restructuring Support Agreement to reduce debt by $1.9 billion and increase free cash flow generation
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Buxton Helmsley Issues Letter to Mallinckrodt Plc. Directors Regarding Bankruptcy Negotiations and Financial Disclosure Violations

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Buxton Helmsley Group accuses Mallinckrodt of accounting and securities fraud, highlights inaccurate representations of CFO
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FAQ

What is the market cap of Mallinckrodt plc (MNK)?

The market cap of Mallinckrodt plc (MNK) is approximately 4.5M.

What is Mallinckrodt's core business?

Mallinckrodt develops, manufactures, markets, and distributes specialty pharmaceutical products and medical imaging agents, focusing on therapeutic drugs for autoimmune and rare diseases, immunotherapy, neonatal respiratory critical care therapies, and analgesics.

What recent achievements has Mallinckrodt made?

Recent achievements include health economics outcomes research on Acthar® Gel, showing its cost-effectiveness for certain conditions, and new data on TERLIVAZ® demonstrating its efficacy in improving kidney function in patients with hepatorenal syndrome.

What are the key segments of Mallinckrodt's business?

Mallinckrodt's business is divided into three key segments: Specialty Brands (branded medicines), Specialty Generics (generic drugs and active pharmaceutical ingredients), and Global Medical Imaging (contrast media and nuclear imaging agents).

What is Acthar® Gel?

Acthar® Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. It is approved by the FDA for treating several autoimmune disorders and inflammatory conditions.

What is TERLIVAZ® used for?

TERLIVAZ® (terlipressin) is used to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function, an acute and life-threatening condition.

What financial performance did Mallinckrodt report for Q1 2024?

Mallinckrodt reported net sales of $467.8 million for the first quarter of 2024, reflecting a 10.2% increase compared to the same period in 2023.

What new product did Mallinckrodt recently launch?

Mallinckrodt recently launched the Acthar® Gel Single-Dose Pre-filled SelfJect™ Injector, designed to provide patients with better control over their medication administration.

How does Mallinckrodt support patients using Acthar® Gel?

Mallinckrodt offers a suite of support services for eligible Acthar® Gel patients, including insurance coverage assistance, commercial copay assistance, a patient assistance program, injection training services, and nurse navigator support.

What is the significance of Mallinckrodt's specialty generics segment?

Mallinckrodt's Specialty Generics segment includes high-quality generic drugs and active pharmaceutical ingredients, serving a critical role in the market by ensuring a stable supply of essential medicines amidst ongoing shortages and supply chain constraints.

Where can investors find more information about Mallinckrodt?

Investors can find more information on Mallinckrodt's website, particularly in the Investor Relations section, which provides updates on company performance, press releases, and financial information.

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Mallinckrodt plc

NYSE:MNK

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MNK Stock Data

4.52M
5.72M
10.09%
96.64%
13.46%
Drug Manufacturers - Specialty & Generic
Healthcare
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Ireland
Dublin