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Case Status:    SETTLED
On or around 06/09/2016 (Other)

Filing Date: May 08, 2013

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.

COMPANY INFORMATION:

Sector:
Industry:
Headquarters: United States

SECURITIES INFORMATION:

Ticker Symbol: DCTH
Company Market: NASDAQ
Market Status: Public (Listed)

About the Company & Securities Data


"Company" information provides the industry and sector classification and headquarters state for the primary company-defendant in the litigation. In general, "Securities" information provides the ticker symbol, market, and market status for the underlying securities at issue in the litigation.

In most cases, the primary company-defendant actually issued the securities that are the subject of the litigation, and the securities information and company information relate to the same entity. In a small subset of cases, however, the primary company-defendant is not the issuer (for example, cases against third party brokers/dealers), and the securities information and company information do not relate to the same entity.
COURT: S.D. New York
DOCKET #: 13-CV-03116
JUDGE: Hon. Lorna G. Schofield
DATE FILED: 05/08/2013
CLASS PERIOD START: 04/21/2010
CLASS PERIOD END: 05/02/2013
PLAINTIFF FIRMS NAMED IN COMPLAINT:
  1. Bronstein, Gewirtz & Grossman, LLC (New York)
    60 East 42nd Street - Suite 4600, Bronstein, Gewirtz & Grossman, LLC (New York), NY 10165
    212.697.6484 212.697.7296 · info@bgandg.com
  2. Pomerantz LLP (New York)
    600 Third Avenue, Pomerantz LLP (New York), NY 10016
    212.661.1100 212.661.8665 · info@pomerantzlaw.com/
No Document Title Filing Date
COURT: S.D. New York
DOCKET #: 13-CV-03116
JUDGE: Hon. Lorna G. Schofield
DATE FILED: 10/01/2013
CLASS PERIOD START: 04/21/2010
CLASS PERIOD END: 09/13/2013
PLAINTIFF FIRMS NAMED IN COMPLAINT:
  1. Bronstein, Gewirtz & Grossman, LLC (New York)
    60 East 42nd Street - Suite 4600, Bronstein, Gewirtz & Grossman, LLC (New York), NY 10165
    212.697.6484 212.697.7296 · info@bgandg.com
  2. Pomerantz Haudek Block Grossman & Gross LLP (Chicago)
    10 South LaSalle Street, Suite 3505, Pomerantz Haudek Block Grossman & Gross LLP (Chicago), IL 60603
    312.377.1181 312.377.1181 ·
  3. Pomerantz LLP (New York)
    600 Third Avenue, Pomerantz LLP (New York), NY 10016
    212.661.1100 212.661.8665 · info@pomerantzlaw.com/
No Document Title Filing Date