According to the law firm press release, Delcath Systems, Inc. operates as a specialty pharmaceutical and medical device company focusing on the field of oncology. The company's proprietary technology enables the administration of high-dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents.
The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, as
well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (1) the Company's New Drug Application ("NDA") for Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), for the treatment of patients with unresectable ocular melanoma metastatic to the liver contained risks including substantial and severe toxicity and deaths associated with the drug's adverse reactions; and (2) the Company's manufacturing facilities were in violation of Current Good Manufacturing Practices ("cGMP").
On February 22, 2011, the Company disclosed that it had received a "refusal to file" letter from the U.S. Food &
Drug Administration ("FDA") for its NDA for its proprietary chemosaturation system. The letter "requested information
involving manufacturing plant inspection timing, product and sterilization validations and additional safety information
[...] as well as additional statistical analysis clarification." On this news, Delcath shares plummeted $4.29 or 38%, to
close at $7.01 per share.
On April 30, 2013, the FDA published briefing documents ahead of a May 2, 2013 meeting by the Oncologic Drugs Advisory Committee ("ODAC"). The briefing documents concluded, among other things, that "substantial evidence of effectiveness in adequate and well controlled clinical trials utilizing the proposed drug-device combination product and a favorable benefit risk profile is required for approval. "Moreover, the briefing documents revealed that a staggering 7% of the 122 patients treated with the Melbaz kit died as a result of the treatment. On this news, Delcath shares declined $0.558 per share or over 40%, to close at $0.832 per share on April 30, 2013.
On May 2, 2013, the Company announced that the ODAC voted 16 to 0 that benefits of treatment with Delcath's
Melblez Kit do not outweigh the risks associated with the procedure. On this news, Delcath shares declined $0.3326 per share or nearly 42%, to close at $0.46 per share on May 3, 2013.
On August 2, 2013, the Delcath Systems Group, Inc. was appointed Lead Plaintiff for the Class and Pomerantz Grossman Hufford Dahlstrom & Gross LLP was appointed Lead Counsel.
On September 18, 2013, a Corrected Amended Class Action Complaint was filed by the lead plaintiffs against the defendants.
On May 21, 2015, the parties entered into a Stipulation of Settlement. This Settlement was preliminarily approved by the Court on June 24. On October 22, 2015, the Court granted final approval of the Settlement and dismissed this case with prejudice.