Key Developments: Delcath Systems Inc (DCTH.PH)

DCTH.PH on Philadelphia Stock Exchange

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8 Aug 2014
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Latest Key Developments (Source: Significant Developments)

Delcath Systems Inc To Raise Approximately $7.5 Million
Wednesday, 23 Oct 2013 08:47am EDT 

Delcath Systems Inc announced that it is raising approximately $7.5 million in gross proceeds in an offering of 20,960,000 shares of its common stock and warrants to purchase up to 9,432,000 shares of common stock at a combined price to the public of $0.36 per share and related warrant. The warrants are exercisable beginning on the date six months after the date of issuance at an exercise price of $0.44 per share and will expire, unless exercised, on the fifth anniversary of the date of issuance. The net proceeds from the sale of the shares and the related warrants, after deducting the placement agent fees and other estimated offering expenses payable by Delcath, will be approximately $6.8 million, which does not include any potential proceeds from the cash exercise of any warrants. Delcath intends to use the net proceeds from this offering (including any resulting from the exercise of the warrants, if any) for general corporate purposes, including, but not limited to, funding of its clinical trials, commercialization of its products, obtaining regulatory approvals, research, capital expenditures and working capital. Roth Capital Partners, LLC, served as sole placement agent. The offering is expected to close on October 28, 2013, subject to customary closing conditions.  Full Article

Delcath Systems Inc Announces Strategic Reorganzation
Friday, 4 Oct 2013 06:30am EDT 

Delcath Systems Inc announced that as part of its efforts to increase operating efficiencies, the Company has completed a strategic reorganization under which it has eliminated 21 positions, or approximately 33% of its global workforce. The Company expects this reorganization, in conjunction with other cost saving measures, to significantly lower cash utilization.  Full Article

U.S. FDA Grants Orphan Drug Designation To Delcath Systems Inc For Use Of Melphalan Hydrochloride In HCC
Tuesday, 1 Oct 2013 04:30pm EDT 

Delcath Systems Inc announced that the U.S. Food & Drug Administration (FDA) has granted the Company orphan drug designation for melphalan in the treatment of patients with hepatocellular carcinoma (HCC, or primary liver cancer). Orphan-drug designation is granted by the FDA Office of Orphan Products Development to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication. It also provides tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees. Melphalan for use with the Delcath Hepatic Delivery System is not currently approved in the United States for the treatment of patients with HCC.  Full Article

Delcath Systems Inc Announces Leadership Changes
Friday, 13 Sep 2013 06:00am EDT 

Delcath Systems Inc announced that that the Company's Board of Directors has implemented a leadership transition plan under which Jennifer Simpson, Ph.D., M.S.N., C.R.N.P., the Company's current Executive Vice President, Global Head of Business Operations, and Graham Miao, Ph.D., M.S., MBA the Company's current Executive Vice President and Chief Financial Officer, have been appointed to serve as Interim Co-President and Co-Chief Executive Officers. The employment of Eamonn P. Hobbs as President and Chief Executive Officer with the Company was terminated as of September 10, 2013; Mr. Hobbs has also resigned from the Board of Directors. In addition to her role as Interim Co-President and Co-Chief Executive Officer, Dr. Simpson shall continue to serve as the Company's Executive Vice President, Global Head of Business Operations. In addition to his role as Interim Co-President and Co-Chief Executive Officer, Dr. Miao shall continue to serve as the Company's Executive Vice President, Chief Financial Officer.  Full Article

Delcath Systems Inc Receives Complete Response Letter From FDA For Melbleztm Kit New Drug Application
Friday, 13 Sep 2013 06:00am EDT 

Delcath Systems, Inc announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) received September 12, 2013 regarding the New Drug Application (NDA) for Delcath's MelblezTM 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.  Full Article

Pomerantz Law Firm Reminds Shareholders With Losses on Their investment in Delcath Systems Inc of Class Action Lawsuit and Upcoming Deadline
Sunday, 7 Jul 2013 10:00am EDT 

Pomerantz Grossman Hufford Dahlstrom & Gross LLP announced that it has filed a class action lawsuit against Delcath Systems Inc and certain of its officers. The class action, filed in United States District Court, Southern District of New York, and docketed under 13 CIV 3116, is on behalf of a class consisting of all persons or entities who purchased or otherwise acquired securities of Delcath between April 21, 2010 and May 2, 2013, both dates inclusive (the Class Period). 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).  Full Article

Faruqi & Faruqi, LLP Encourages Investors Who Suffered Losses in Excess of $100,000 Investing in Delcath Systems Inc to Contact Firm
Wednesday, 3 Jul 2013 08:37pm EDT 

Faruqi & Faruqi, LLP, a ational securities law firm, reminded investors of Delcath Systems Inc of the July 8, 2013 deadline to seek the role of lead plaintiff in a federal securities class action lawsuit filed against the Company and certain executives. A complaint has been filed on behalf of all persons who purchased or otherwise acquired Delcath securities between April 21, 2010 and May 2, 2013 (the "Class Period"). The action alleges that the Company and its executives violated federal securities laws by failing to disclose that: (1) the Company's New Drug Application ("NDA") for Melblez Kit for the treatment of patients with unresectable ocular melanoma metastatic to the liver contained risks including fatal levels of toxicity associated with the drug's adverse reactions; and (2) the Company's manufacturing facilities were in violation of the United States' Current Good Manufacturing Practices ("cGMP"). On February 22, 2011, Delcath disclosed that it had received a "refusal to file" letter from the U.S. Food & Drug Administration ("FDA") requesting "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.  Full Article

Saxena White P.A. Files Securities Fraud Class Action Against Delcath Systems Inc
Monday, 17 Jun 2013 02:50pm EDT 

Saxena White P.A. announced that it has filed a securities fraud class action lawsuit in the United States District Court for the Southern District of New York against Delcath Systems Inc and certain of the Company's executive officers. The class action is filed on behalf of investors who purchased or otherwise acquired Declath's common stock during the period from April 21, 2010 and May 2, 2013, inclusive (the Class Period). The complaint brings claims for violations of the Securities Exchange Act of 1934.  Full Article

Pomerantz Law Firm Reminds Shareholders With Losses on Their Investment In Delcath Systems Inc. Of Class Action Lawsuit And Upcoming Deadline
Friday, 14 Jun 2013 04:25pm EDT 

Pomerantz Grossman Hufford Dahlstrom & Gross LLP announced that it has filed a class action lawsuit against Delcath Systems, Inc. (Delcath or the Company) and certain of its officers. The class action, filed in United States District Court, Southern District of New York, and docketed under 13 CIV 3116, is on behalf of a class consisting of all persons or entities who purchased or otherwise acquired securities of Delcath between April 21, 2010 and May 2, 2013, both dates inclusive (the Class Period). This class action seeks to recover damages against the Company and certain of its officers and directors as a result of alleged violations of the federal securities laws pursuant to Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder.  Full Article

Lifshitz Law Firm Announces Investigation Of Delcath Systems Inc
Tuesday, 28 May 2013 09:11pm EDT 

Lifshitz Law Firm announced that a class action suit was filed in the United States District Court for the Southern District of New York, alleging that Delcath Systems Inc issued false and misleading statements to investors between April 21, 2010 and May 2, 2013, inclusive (the Class Period) by failing to adequately disclose (1) the Company's New Drug Application (NDA) for Melblez Kit 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). The firm is investigating legal claims against the officers and Board of Directors of Delcath during the Class Period.  Full Article

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