Mallinckrodt PLC

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Mallinckrodt Plc engages in the development, manufacture, market, adn distribution of both branded and generic specialty pharmaceutical products and medical imaging agents. It operates through the Specialty Brands and Specialty Generics segments. The Specialty Brands segment includes innovative specialty pharmaceutical brands. The Specialty Generics segment relates to niche specialty generic drugs and active pharmaceutical ingredients. The company was founded by Gustavo Mallinckrodt, Otto Mallinckrodt and Edward Mallinckrodt in 1867 and is headquartered in Blanchardstown, Dublin.

Third Quarter Net Sales of $497.0 Million Reflects 6.8% Growth Compared to the Prior Year Quarter Acthar® Gel (Repository Corticotropin Injection) Delivery Device Supplemental New Drug Application Accepted by U.S. Food and Drug Administration Financial Restructuring Plan Approved by U.S. Bankruptcy Court; Company Poised to Complete Irish Examinership and Emerge from Chapter 11 in the Near Term DUBLIN , Nov. 7, 2023 /PRNewswire/ -- Mallinckrodt plc (in examinership) (OTCMKTS: MNKTQ) ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today reported its financial results for the third quarter ended September 29, 2023. "Mallinckrodt's results underscore our relentless focus on stabilizing the business.

Mallinckrodt plc (in Examinership) Reports Third Quarter 2023 Financial Results

–Three scientific abstracts via one oral and two poster presentations detail the Company's latest clinical research findings on the therapeutic effect of TERLIVAZ for adults with HRS involving rapid reduction in kidney function1 – DUBLIN , Nov. 1, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that three scientific abstracts evaluating treatment with TERLIVAZ® (terlipressin) for injection for adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 – including its impact on patient care, key HRS endpoints and patient comorbidity – will be presented at the American Society of Nephrology (ASN) Kidney Week 2023 Scientific Meeting in Philadelphia, Pennsylvania, taking place November 2-5, 2023. TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2 Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.

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

-- Findings from two health economics analyses of Acthar Gel provide further insight into its cost-effectiveness as a treatment option for advanced symptomatic sarcoidosis,1 and its impact on clinical, economic, and real-world outcomes in patients with nephrotic syndrome2 -- DUBLIN , Oct. 26, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, recently shared findings from Mallinckrodt's latest health economics outcomes research on Acthar® Gel (repository corticotropin injection) for patients with advanced symptomatic sarcoidosis and nephrotic syndrome (NS)1,2 at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 in Orlando, FL October 16-19, 2023. A full list of accepted abstracts presented at AMCP Nexus 2023 can be found here.

Mallinckrodt Presents Latest Health Economics Data on Acthar® Gel (Repository Corticotropin Injection) at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023

– Findings from two clinical studies and one health economic database analysis provide insight into HRS treatment outcomes with TERLIVAZ,1 patients' cardiac health2 and association between hospital size and overall outcomes for chronic liver disease patients3 – DUBLIN , Oct. 22, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that three posters detailing findings from Mallinckrodt's latest clinical and health economics outcomes research with TERLIVAZ® (terlipressin) for injection for adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1,2,3,4 will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Vancouver, British Columbia, taking place October 20-25, 2023. TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,4 an acute and life-threatening condition requiring hospitalization.5 TERLIVAZ is not approved in Canada.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American College of Gastroenterology (ACG) Annual Scientific Meeting

Prescription opioid maker Mallinckrodt MNKTQ on Tuesday gained federal court approval to erase more than $1 billion of payments intended for people with drug addiction while handing control of the pharmaceutical company to its lenders. The U.S. Bankruptcy Court in Wilmington, Del.

Mallinckrodt bankruptcy plan gains approval from federal court

– Clinical findings from historical manuscript published in Clinical Drug Investigation reinforce the efficacy, safety profile, and use of Acthar Gel in appropriate patients across 12 autoimmune and inflammatory indications1 – – Economic findings from manuscript published in ClinicoEconomics and Outcomes Research support Acthar Gel's clinical and economic benefits for patients across nine autoimmune and inflammatory indications2 – DUBLIN , Oct. 10, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced the publication of two journal manuscripts reinforcing the clinical and economic evidence supporting the efficacy, safety profile, continued use, and cost-effectiveness of Acthar Gel for appropriate patients across a range of FDA-approved autoimmune and inflammatory disease indications.1,2  Mallinckrodt's clinical manuscript titled "Acthar Gel Treatment for Patients with Autoimmune and Inflammatory Diseases: A Historical Perspective and Characterization of Clinical Evidence" was published on October 4, 2023 in the journal, Clinical Drug Investigation.  Mallinckrodt's health economics manuscript titled "Acthar Gel (RCI): A Narrative Literature Review of Clinical and Economic Evidence" was published on June 24, 2023 in ClinicoEconomics and Outcomes Research.

Mallinckrodt Announces Publication of Two Journal Manuscripts with Clinical and Economic Evidence for Acthar® Gel (Repository Corticotropin Injection)

NEW YORK--(BUSINESS WIRE)--The Buxton Helmsley Group, Inc. (together with certain of its affiliates, “BHG” or “we”), the New York City-based investment advisor to certain clients with financial interests in Mallinckrodt Plc. (“Mallinckrodt” or the “Company”) (NYSE: MNK), today issued the following statement regarding the Company's August 28, 2023, filing for Chapter 11 bankruptcy protection in the U.S. Bankruptcy Court for the District of Delaware (Case No. 23-11258): “We have reviewed the Comp.

Buxton Helmsley Issues Statement on Mallinckrodt plc. Bankruptcy Filing and Disclosures Revealing Apparently Concealed Intangible Asset Depreciation Expenses

LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz reminds investors of the upcoming September 5, 2023 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who acquired Mallinckrodt plc (“Mallinckrodt” or the “Company”) (NYSE: MNK) securities between June 17, 2022 and June 14, 2023, inclusive (the “Class Period”). If you are a shareholder who suffered a loss, click here to participate. In October 2020, Mallinckrodt filed for Chapter 11 bankruptcy.

The Law Offices of Frank R. Cruz Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Mallinckrodt plc (MNK)

Takeda Pharmaceutical

Viatris

Drugmakers have begun shipping copycat versions of Takeda Pharmaceutical's drug Vyvanse, which is expected to offset the ongoing shortage of the ADHD medicine in the United States.

Generic drugmakers start shipping copies of Takeda's ADHD drug Vyvanse

DUBLIN , Aug. 31, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that its Specialty Generics segment, operating as SpecGx LLC, received approval on August 25, 2023 from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Lisdexamfetamine Dimesylate Capsules 10mg, 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg. The FDA determined SpecGx LLC's product was bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vyvanse® Capsules of Takeda Pharmaceuticals U.S.A.

Mallinckrodt Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate Capsules and Launches Product Used to Treat Attention-Deficit/Hyperactivity Disorder (ADHD)

LOS ANGELES , Aug. 30, 2023 /PRNewswire/ -- The Law Offices of Frank R. Cruz announces that investors with substantial losses have opportunity to lead the securities fraud class action lawsuit against Mallinckrodt plc ("Mallinckrodt" or the "Company") (NYSE: MNK).

MNK Investors Have Opportunity to Lead Mallinckrodt plc Securities Fraud Lawsuit

Continuing to Serve Customers and Deliver High-Quality Therapies to Patients Without Interruption; Vendors and Suppliers to be Paid in Full in the Ordinary Course DUBLIN , Aug. 30, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ) ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today announced that it has received approvals from the U.S. Bankruptcy Court for the District of Delaware for its "First Day" motions related to the Company's voluntary Chapter 11 petitions filed on August 28, 2023. As expected, the Court granted Mallinckrodt approval to access $150 million of the $250 million of commitments for new financing it received from certain of its creditors, as well as new borrowing availability from lenders under its asset-based loans.

Mallinckrodt Receives Court Approval for "First Day" Motions to Support Ongoing Operations

NEW YORK--(BUSINESS WIRE)--NYSE American LLC (“NYSE American” or the “Exchange”) announced today that the staff of NYSE Regulation has determined to commence proceedings to delist the Ordinary Shares of Mallinckrodt plc (the “Company”) — ticker symbol MNK — from NYSE American. Trading in the Company's Ordinary Shares will be suspended immediately. NYSE Regulation has determined that the Company is no longer suitable for listing and will commence delisting proceedings pursuant to Section 1003(c).

NYSE American to Commence Delisting Proceedings Against Mallinckrodt plc (MNK)

News for Mallinckrodt PLC Stock (MNKTQ)