According to the Plaintiff's law firm press release, Mallinckrodt Public Limited Company and its subsidiaries develops, manufactures, markets, and distributes specialty pharmaceutical products and therapies in the United States and internationally. It operates in two segments, Specialty Brands, and Specialty Generics and Amitiza. The Company markets its branded products to physicians, pharmacists, pharmacy buyers, hospital procurement departments, ambulatory surgical centers, and specialty pharmacies.

Among other products, Mallinckrodt’s portfolio includes H.P. Acthar Gel (“Acthar”), an injectable drug for various indications, such as rheumatoid arthritis, multiple sclerosis, infantile spasms, systemic lupus erythematosus, polymyositis, and others. During the Class Period, Acthar was in a Phase 2B study designed to assess its efficacy and safety as an investigational treatment for amyotrophic lateral sclerosis (“ALS”).

The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations and compliance policies. Specifically, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose that: (i) Acthar posed significant safety concerns that rendered it a non-viable treatment for ALS; (ii) accordingly, Mallinckrodt overstated the viability of Acthar as an ALS treatment; and (iii) as a result, the Company’s public statements were materially false and misleading at all relevant times.

Plaintiff re-filed the Complaint on July 29, 2019. On June 25, 2020, the Court issued an Order appointing Lead Plaintiff and Counsel. On July 30, the Court issued an Order transferring this case to the District of New Jersey. Lead Plaintiff filed an amended Complaint on August 10.

On December 10, 2020, the Court issued an Order staying the case due to proceedings in the United States Bankruptcy Court for the District of Delaware. On March 29, 2022, the Court ordered the litigation reinstated with respect to the Individual Defendants. Plaintiff voluntarily dismissed the Company Issuer on December 13, 2022.

Defendants filed a Motion to Dismiss the amended Complaint on October 1, 2020. On December 16, 2022, the Court issued an Order denying Defendants' Motion to Dismiss.

On September 18, 2024, the parties entered into a Stipulation of Settlement.