June 26, 2013 (Shareholders Foundation) - An investor, who currently holds NASDAQ:DCTH shares, filed a lawsuit against the members of the board of directors of Delcath Systems, Inc. over alleged breaches of fiduciary duties.
The plaintiff alleges that members of the board of directors made allegedly false and/or misleading statement and/or failed to disclose that Delcath Systems’ New Drug Application for Melblz identified risks including substantial and severe toxicity and deaths associated with the drug’s adverse reactions, and that Delcath Systems’ manufacturing facilities were in violation of current good manufacturing practices.

The plaintiff says that the board of directors of Delcath Systems caused the company to make false and misleading financial statements and that the members of the board of directors of Delcath Systems have subjected the company to substantial losses, adverse publicity, additional costs, potential fines, and other damages.

On February 22, 2011, Delcath Systems disclosed that it had received a refusal to file letter from the U.S. Food & Drug Administration ( FDA ). Shares of Delcath Systems declined from $11.30 per share on Feb. 18, 2011 to $6.29 per share on Feb. 25, 2011.

On April 30, 2013, the FDA published briefing documents ahead of a May 2, 2013 meeting by the Oncologic Drugs Advisory Committee.Shares of Delcath Systems declined from $1.51 per share on April 29, 2013, to $0.78 per share on April 30, 2013.

Then on May 2, 2013, Delcath Systems, Inc. announced that the FDA Advisory Committee voted 16-0 against recommending the company's Melblez kit therapy for treatment of hepatic-dominant metastatic ocular melanoma.Shares of Delcath Systems, Inc. (NASDAQ:DCTH) declined from $1.505 per share on April 29, 2013, to $0.381 per share on June 7, 2013.

On June 25, 2013, NASDAQ:DCTH shares closed at $0.40 per share.