Key Developments: Delcath Systems Inc (DCTH.PH)
0.42USD
22 May 2013
$0.00 (+0.10%)
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2,700
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Latest Key Developments (Source: Significant Developments)
Brower Piven Announces Class Action Lawsuit Against Delcath Systems Inc
Brower Piven announced that a class action lawsuit has been commenced in the United States District Court for the Southern District of New York on behalf of purchasers of Delcath Systems Inc common stock during the period between April 21, 2010 and May 2, 2013, inclusive (the Class Period). Full Article
Glancy Binkow & Goldberg LLP Announces Class Action Lawsuit Against Delcath Systems Inc
Glancy Binkow & Goldberg LLP announces that a class action lawsuit has been filed in the United States District Court for the Southern District of New York on behalf of a class comprising all purchasers of the securities of Delcath Systems Inc between April 21, 2010 and May 2, 2013, inclusive. The Complaint alleges that throughout the Class Period defendants misrepresented or failed to disclose material adverse facts about, among other things, the Company's New Drug Application seeking Food and Drug Administration (FDA) approval for commercial sale of 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, including substantial and severe toxicity, and deaths associated with the drug`s adverse reactions. Full Article
Briscoe Law and Powers Taylor Investigate Possible Breaches of Fiduciary Duty by Officers and Directors Of Delcath Systems Inc
Former United States Securities and Exchange Commission attorney Willie Briscoe, founder of The Briscoe Law Firm, PLLC, and the securities litigation firm of Powers Taylor, LLP announce that a federal class action lawsuit has been filed against Delcath Systems Inc. The firms are investigating additional legal claims against the officers and Board of Directors of Delcath during the period of April 21, 2010 and May 2, 2013 (the "Class Period"). Full Article
Federman & Sherwood Announces That Securities Class Action Lawsuit Has Been Filed Against Delcath Systems Inc
On May 8, 2013, a class action lawsuit was filed in the United States District Court for the Southern District of New York against Delcath Systems Inc. The complaint alleges violations of federal securities laws, Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5, including allegations of issuing a series of material or false misrepresentations to the market which had the effect of artificially inflating the market price during the Class Period, which is April 21, 2010 through May 2, 2013. Full Article
Pomerantz Law Firm Files Class Action Against Delcath Systems Inc
Pomerantz Grossman Hufford Dahlstrom & Gross LLP has filed a class action lawsuit against Delcath Systems, Inc. and certain of 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. This class action seeks to recover damages against the Company and certain of 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. 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 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 the Company's manufacturing facilities were in violation of Current Good Manufacturing Practices (cGMP). Full Article
Bronstein, Gewirtz & Grossman, LLC Announces Investigation Of Delcath Systems Inc
Bronstein, Gewirtz & Grossman, LLC announced that it is investigating potential claims on behalf of purchasers of the securities of Delcath Systems, Inc. (Delcath). The investigation focuses on whether the Company and its executives violated federal securities laws. On May 2, 2013, shares of the Company plunged in after hour trading after an FDA Advisory Committee voted 16-0 against recommending the Company's Melblez kit therapy for treatment of hepatic-dominant metastatic ocular melanoma. In the FDA staff briefing released, reviewers noted that substantial and severe toxicity was identified in the clinical trials, with 7% of the 122 patients treated by the drug-device combination dying as a result of treatment related side effects. The Company failed to disclose all these risks and other material issues in its Phase 3 trials to investors. DCTH shares have fallen $.99 to $.40 (-71%) since the time the FDA Advisory Committee disclosed its briefing documents and ultimately held its vote. Full Article
Delcath Systems Inc Submits New Drug Application For Chemosaturation System To U.S. Food And Drug Administration
Delcath Systems Inc announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for the Company's chemosaturation system for use with melphalan hydrochloride in the treatment of patients with unresectable metastatic melanoma in the liver. The Company included its Generation 2 filter in its NDA submission as a technical change to the Chemistry, Manufacturing, and Control (CMC) module. Full Article
Delcath Systems Inc Announces Post-Hoc Analysis Of Phase 3 Trial Presented At ASCO
Delcath Systems, Inc announced that an exploratory analysis of the Company's Phase 3 trial was presented at the American Society of Clinical Oncology (ASCO) held in Chicago, IL. The poster— Percutaneous Hepatic Perfusion (PHP) with Melphalan in Patients with Unresectable Liver Metastases from Melanoma: A Post-Hoc Analysis of PHP Randomized vs. Best Alternative Care (BAC)-to-PHP Crossover vs. BAC Only Patients-was presented by Dr. Richard Alexander, Associate Chairman for Clinical Research and Surgery at the University of Maryland Medical Center, on behalf of the Company's Phase 3 trial investigators. e exploratory analysis compared patients assigned to BAC who crossed over to PHP after disease progression with those who did not and with those randomized to PHP-melphalan (chemosaturation therapy). The analysis found that as measured by the trial's primary endpoint of hepatic progression free survival (hPFS), the BAC-cross over arm of the study was consistent with the hPFS achieved in patients randomized directly to the chemosaturation arm. Furthermore, the study showed that crossover from BAC to the chemosaturation arm led to a median overall survival benefit of 11 months compared to treatment with BAC alone. The safety profile of chemosaturation in patients that crossed-over from BAC and patients randomized directly to chemosaturation was similar. Dr. Alexander concluded that chemosaturation is a new treatment option for unresectable metastatic melanoma in the liver. Full Article
Delcath Systems Inc Prices $20 Million Public Offering Of Common Stock
Delcath Systems Inc announced that it has priced an underwritten public offering of 13,333,340 shares of its common stock and warrants to purchase up to 4,000,002 shares of common stock at a combined price to the public of $1.50 per share and related warrant for gross proceeds of $20 million. The warrants are exercisable at an exercise price of $1.65 per share and will expire, unless exercised on the third anniversary of the date of issuance. The net proceeds from the sale of the shares and the related warrants, after deducting the underwriters' discounts and other estimated offering expenses payable by Delcath, will be approximately $18.4 million, which does not include any potential proceeds from the cash exercise of any warrants. Delcath has also granted the underwriters a 30-day option to purchase up to an additional 15% of shares of common stock and warrants offered in the public offering to cover over-allotments. The proceeds of the offering will primarily be used for general corporate purposes, including, but not limited to, commercialization of our products, obtaining regulatory approvals, funding of our clinical trials, research, capital expenditures and working capital. The offering is expected to close on or about May 31, 2012, subject to the satisfaction of customary closing conditions. Cowen and Company, LLC and Wedbush PacGrow Life Sciences are acting as joint book-runners for the offering. Roth Capital Partners is acting as co-manager for the offering. Full Article
Delcath Systems Inc Proposes Public Offering Of Common Stock And Warrants
Delcath Systems Inc announced its intention to offer, subject to market and other conditions, shares of its common stock and warrants to purchase shares of common stock in an underwritten public offering. Delcath also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock and warrants offered in the public offering to cover over-allotments, if any. The proceeds of the offering will primarily be used for general corporate purposes, including, but not limited to, commercialization of the Compnay's products, obtaining regulatory approvals, funding of the clinical trials, research, capital expenditures and working capital. Cowen and Company, LLC and Wedbush PacGrow Life Sciences are acting as joint book-runners for the offering. Roth Capital Partners is acting as co-manager for the offering. Full Article
FDA advisers recommend against Delcath's cancer therapy
- A panel of advisers to the U.S. health regulator unanimously recommended against approving Delcath Systems Inc's cancer therapy for a rare form of eye cancer that spreads to the liver, saying it was too risky.
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