Mallinckrodt plc

On July 16, 2019, post-market, Mallinckrodt revealed that the Company “is permanently discontinuing its Phase 2B study designed to assess the efficacy and safety of Acthar® Gel (repository corticotropin injection) as an investigational treatment for amyotrophic lateral sclerosis (ALS).” Mallinckrodt stated that it decided “to halt the trial after careful consideration of a recent recommendation by the study’s independent Data and Safety Monitoring Board (DSMB).” This “was based on the specific concern for pneumonia, which occurred at a higher rate in the ALS patients receiving Acthar Gel compared to those on placebo,” and “other adverse events specific to this patient population.”

On this news, Mallinckrodt’s stock price fell $0.64 per share, or nearly 8%, to close at $7.56 per share on July 17, 2019, thereby injuring investors.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that Acthar posed significant safety concerns that rendered it a non-viable treatment for ALS; (2) that, accordingly, Mallinckrodt overstated the viability of Acthar as an ALS treatment; and (3) that, as a result, the Company’s public statements were materially false and misleading at all relevant times.