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DCTH

Delcath Systems, Inc.

6/18/2013, 10:01 PM ET

Quote & Headlines Market Currents StockTalk

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Wednesday, May 8, 5:22 PM More on Delcath Systems (DCTH): Q1 comes up short on a per share basis but beats on the revenue side. Most of the revenue gain was related to the recognition of previously deferred revenue as a result of satisfying certain requirements of the its Research and Distribution agreement with Chi-Fu Trading in Taiwan, while the remainder was from product sales. SG&A and R&D expenses both declined, primarily due to a significant reduction in expenses related to the its New Drug Application submission to the FDA. Shares -4% AH. Comment! [Earnings, On the Move]
Wednesday, May 8, 5:21 PM Delcath (DCTH): Q1 EPS loss of -$0.15 misses by $0.02. Revenue of $400K (+42% Y/Y) beats by $120K. (PR). Shares -4% AH. Comment! [Healthcare, Earnings, Breaking News, On the Move]
Friday, May 3, 9:54 AM Delcath Systems (DCTH -48.9%) collapses after the FDA votes unanimously against the company's Melblez Kit, as the risks purportedly outweigh the benefits. The shares were halted Thursday pending the announcement. DCTH is the second casualty of this week's Oncologic Drugs Advisory Board, as Aveo Pharmaceuticals (AVEO +1.5%) received a similarly disappointing panel vote on Tivozanib. (Background: I, II) Comment! [Healthcare, On the Move]
Thursday, May 2, 1:34 PM Shares of Delcath Systems (DCTH +4.7%) are halted as the FDA's Oncologic Drugs Advisory Committee meets to discuss its new drug application for marketing approval of its its Melblez Kit for Injection, which is used to treat patients with unresectable ocular melanoma metastatic to the liver. The stock had been hit hard last week after the FDA expressed concern over the treatment's high death rate. 2 Comments [Healthcare, On the Move]
Tuesday, April 30, 12:46 PM Midday top 10 gainers: TTHI +45%. PTIE +26%. DRRX +26%. MTOR +23%. MGAM +20%. OIS +16%. GIB +14%. HGSH +15%. ARWR +13%. TXRH +13%.
Midday top 10 losers: DCTH -44%. AVEO -26%. NUAN -18%. AOSL -18%. PBI -16%. AEIS -13%. MSTR -10%. ANV -10%. ELTK -10%. SYN -10%. Comment! [On the Move]
Tuesday, April 30, 9:44 AM Delcath Systems (DCTH -12.9%) opens sharply lower after the FDA posts a briefing document for the Oncologic Drugs Advisory Committee's discussion of DCTH's ocular melanoma injection Melblez on its website. 2 Comments [Healthcare, On the Move]
Tuesday, April 30, 9:10 AM Premarket gainers: HPY +10%. HTWR +9%. ANAD +9%. AVP +8%. UBS +7%. BBY +6%.
Losers: DCTH -20%. AVEO -16%. NUAN -15%. PBI -10%. MTG -8%. CNH -6%. RVBD -6%. QGEN -5%. Comment! [On the Move]
Tuesday, April 9, 1:08 PM Delcath Systems (DCTH -8.8%) takes a hit today after announcing that it is expanding workforce reductions in an effort to reduce costs. It now says it plans to cut up to 21% of its workforce, with allowance for with sufficient resources for at least the next 12 months as the Company pursues three key objectives: FDA approval for its MelblezTM Kit, European commercialization of CHEMOSAT Hepatic Delivery System for melphalan hydrochloride, and ongoing clinical development focused on label expansion. Comment! [Healthcare, On the Move]
Monday, April 8, 9:10 AM Premarket gainers: LUFK +38%. BSDM +34%. BCRX +18%. UNXL +15%. GOL +10%. TSL +7%.
Losers: OMPI -6%. DCTH -5%. Comment! [On the Move]
Monday, April 8, 8:49 AM Delcath Systems (DCTH) -5.1% after the FDA extends by three months the period for deciding whether to approve the company's Melblez Injection for use with the firm's Hepatic Delivery System, its drug/device combination product for the treatment of patients with unresectable ocular melanoma metastatic to the liver. The FDA is now due to give a decision in September. (PR) 1 Comment [On the Move, Healthcare]
Thursday, March 14, 9:15 AM Premarket gainers: MW +15%. EBIX +14%. ARWR +8%. BLDP +6%. FTE +6%.
Losers: ANAD -8%. NBG -7%. DCTH -7%. ETFC -7%. VRA -6%. Comment! [On the Move]
Wednesday, March 13, 7:31 PM More on Delcath Systems (DCTH): Q4 beats on a per share basis but comes up short on the revenue side. SG&A expenses were higher, primarily due to increased EU commercialization expenses, but were largely offset by lower R&D expenses, which reflected lower consulting expenses following the submission FDA applications for its chemosaturation system. The company also filed a shelf registration to sell up to $50M in stock. Shares -8.3% AH. 2 Comments [Healthcare, Earnings, On the Move]
Wednesday, March 13, 4:21 PM Delcath Systems (DCTH): Q4 EPS of -$0.14. Revenue of $200K misses by $130K. (PR) 5 Comments [Earnings, Breaking News, Healthcare]
Monday, March 4, 2:33 PM Delcath (DCTH +10.4%) resumes its trek higher again today, adding to its run over the past few sessions. Late last week, the company said the FDA's Oncologic Drugs Advisory Committee will review a new drug application for it's Melblez KitTM for Injection drug/device combination for use with the Delcath Hepatic Delivery System. Comment! [Healthcare, On the Move]
Wednesday, February 27, 8:09 AM An FDA advisory panel will review on May 2 Delcath's (DCTH) application for using its Hepatic Delivery System and melphalan hydrochloride to treat patients with unresectable ocular melanoma that is metastatic to the liver. Shares are +2.7% but down from earlier highs. (PR) 3 Comments [Healthcare, On the Move]
Tuesday, February 26, 9:10 AM Premarket gainers: CWH +28%. ALC +22%. ARWR +17%. AXTI +8%. SPRD +7%. AUXL +6%. DCTH +5%.
Losers: TWI -10%. VVUS -7%. VSI -7%. EEQ -5%. 1 Comment [On the Move]