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Delcath Systems (DCTH) Nearly Doubles on FDA Orphan Status Announcement

By  +Follow October 2, 2013 7:28AM
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Shares in Delcath Systems (DCTH) nearly doubled Wednesday after the FDA announced that it had granted orphan status to melphalan for treatment of patients with hepatocellular carcinoma (primary liver cancer, also known as HCC). The stock leapt as much as 113 percent on heavy trading before settling into gains of around 90 percent as the day wore on.

Delcath Pops on Good News, Regains Some Lost Ground

Delcath, a specialty pharmaceutical and medical device company, was in the midst of a rough year, down almost 75 percent since the start of 2013. The company’s stock plunged in early May on news that an FDA Advisory panel had unanimously voted against recommending Delcath’s Melblez kit therapy for treatment of hepatic-dominant metastatic ocular melanoma. The 16-0 vote came after reviewers noted that "substantial and severe toxicity" had been identified and seven of the 122 patients in the trial treated by the drug-combo had died as a result of treatment.

Today’s announcement is some much-needed good news for owners of Delcath. Orphan status, which indicates that one of the drugs the company has in development can be used to treat a rare disease, comes with a number of advantages, including tax breaks on research and waived fees. The FDA threshold for orphan drug status is 200,000 or fewer patients in the United States, and there currently only about 26,000 people suffering from primary liver cancer.

Delcath Still Not Out of the Woods

While Delcath’s ChemoStat treatment for HCC has just received certain benefits, it still needs final approval from the FDA. And this is anything but certain, given that just earlier this month the FDA didn’t grant approval for the drug. The FDA’s September 12th letter stated that Delcath needed to perform another "well-controlled randomized trial(s) to establish the safety and efficacy of Melblez Kit using overall survival as the primary efficacy outcome measure" which "demonstrates that the clinical benefits of Melblez Kit outweigh its risks."

However, Delcath’s path to the desired ultimate outcome is smoothed somewhat with the granting of orphan status.

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Results for DCTH
The Street Mentor
29 May 15 07:10:26
$DCTH Nice! http://t.co/KXi3ZVqn1L via @FINVIZ_com
Stephen s
29 May 15 07:08:10
RT @FrankReeberie: $nbri slowly growing strength on bid, $qedn $dcth $tpac $rsii $hjoe
JustWallstreet
29 May 15 07:03:59
$DCTH good short so far, How Low can she go
Stock Trade Alerts
29 May 15 07:02:40
LONG alert updates: $DCTH +22% $OHGI +9% $TBIO +6% | SH #TradeAlerts ➡ via http://t.co/LHfNLyERf1
Stock Horizon LLC
29 May 15 07:00:04
LONG alert updates: $DCTH +22% $OHGI +9% $TBIO +6% http://t.co/boAlZ8eOow
Mr. Moreno
29 May 15 06:59:26
Good entry for $OHGI and $DCTH at this levels
The Trading Ninja
29 May 15 06:53:39
$DCTH Alerted weds @$1 lol http://t.co/Ai50OiHjmY
ML7
29 May 15 06:53:09
$SYMX & $TBIO Alert #pennystock #stock $PBMD $OHGI $INVT $ENZN $DCTH $HMY $BAA $APPL $PTBI $KIRI $XXII $EXTR
Stock Trade Alerts
29 May 15 06:53:07
Price Action Alert $DCTH - DELCATH SYSTEMS #stocks #intraday ~ via #AlertTrade
Jake13
29 May 15 06:52:08
YOKU Youku Tudou, Inc. Stock Forum http://t.co/lyIwpSLVCX $YOKU $DIS $SVXY $DCTH #YOKU #stocks #finance
propshop73
29 May 15 06:50:30
$DCTH took it off +.11
Jake13
29 May 15 06:49:15
XIV VelocityShares Daily Inverse VIX Short Term ETN Shares http://t.co/9RaQXI4pnx $XIV $CVX $DCTH $GOOG #XIV #finance #stockmarket
IH News Desk
29 May 15 06:49:06
VXX iPath S&P 500 VIX Short-Term Futures ETN Shares http://t.co/5HOLyvMmZm $VXX $DCTH $QCOM $GDX #VXX #nasdaq #stockmarket
Bilo Selhi
29 May 15 06:46:47
$DCTH $1.52 cash per share. Still undervalued.
lookn4wins
29 May 15 06:46:09
SLV iShares Silver Trust Investor Opinions http://t.co/2UE7xzXUOe $SLV $AMBA $APPY $DCTH #SLV #stock #pennystocks
Antonio NaVi
29 May 15 06:46:05
I'm checking out $DCTH ... Buen patrón de #GapNGo http://t.co/ykWFrRM1fN
IH News Desk
29 May 15 06:46:04
SPLK Splunk Inc. 52Wk Low http://t.co/hErtlYnG3q $SPLK $GLD $XLB $DCTH #SPLK #pennystocks #finance
propshop73
29 May 15 06:45:14
$DCTH bot 1.58
TimothySykesStudents
29 May 15 06:45:13
9:10AM TimAlerts The_Peoples_Champ: Made $200 $PBMD pre market, happy Friday http://t.co/GmnsSKgpkr $TBIO $HRTX $DCTH $ESI $MX $HMY $EYES
Emylers
29 May 15 06:44:42
RMRK Rimrock Gold Corp. Prev Close http://t.co/Azfz0myXd3 $RMRK $BIDU $DCTH $UGAZ #RMRK #tradeideas #stock
Lucky Jimmy
29 May 15 06:44:04
PPCH Propanc Health Group Corp. Investor Opinions http://t.co/Gxumu0RVUG $PPCH $TSLA $LVGI $DCTH #PPCH #stock #pennystocks
Michael Gorbaty
29 May 15 06:43:29
$DCTH position spikes 40%! from 1.255 opening to over 1.85!
Rosner Stocks
29 May 15 06:43:13
ONCSD OncoSec Medical Inc. Last Price http://t.co/cqbffqIzNd $ONCSD $PMCB $DCTH $ACWI #ONCSD #tradeideas #share
Stock Trade Alerts
29 May 15 06:42:09
$DCTH hit 3rd predicted LONG move $1.88. On watch @ 09:00, alerted @ 09:32 & $1.51. | SH #TradeAlerts ➡ via http://t.co/LHfNLyERf1
SuperNova
29 May 15 06:42:09
09:40 am jersey: out $DCTH 1.21 - 1.89 from yday for +56%, click here to learn how! http://t.co/UMdIUiZKkj
PennyPRO.com
29 May 15 06:42:09
09:40 am jersey: out $DCTH 1.21 - 1.89 from yday for +56%, click here to learn how! http://t.co/jqk03wihtw
Stock Trade Alerts
29 May 15 06:42:08
$DCTH hit 2nd predicted LONG move $1.76. On watch @ 09:00, alerted @ 09:32 & $1.51. | SH #TradeAlerts ➡ via http://t.co/LHfNLyERf1
Stock Trade Alerts
29 May 15 06:42:08
$DCTH triggered LONG, hit 1st predicted LONG move $1.69. On watch @ 09:00, alerted @ 09:32… | SH #TradeAlerts ➡ via http://t.co/LHfNLyERf1
danrocks
29 May 15 06:42:06
MJMJ MaryJane Group, Inc. Day High http://t.co/1ecGQMcDs8 $MJMJ $DCTH $BRWC $HRTX #MJMJ #tradeideas #investing
B-RAD
29 May 15 06:41:48
out $dcth 1.80 in $kbio .59
J Lau
29 May 15 06:41:42
@upstocks13 remember $DCTH from almost a year ago lol
 Luke Murray
29 May 15 06:41:01
$DCTH out 1.68 -.03
Home Day Trading
29 May 15 06:40:49
Stocks in play: $AAPL $FB $TWTR $GPRO $BABA $YOKU $KORS $ANF $BRCM $AVGO $OHGI $AMRN $FEYE $CLLS $GENE $PBMD $ALTR $HRTX $GEVO $GME $DCTH
Investors Hangout
29 May 15 06:40:45
JPM J.P. Morgan Chase & Co. Volume http://t.co/3buXoVHXBl $JPM $DIA $DCTH $ITB #JPM #stockmarket #invest
Stock Horizon LLC
29 May 15 06:39:58
$DCTH hit 3rd predicted LONG move $1.88. On watch @ 09:00, alerted @ 09:32 & $1.51. http://t.co/Va8wI9xfT1
Microcap Stocks
29 May 15 06:39:53
Low float mania continues 3rd month in a row $TBIO $DCTH micro cap stocks judging by volume are the new OTC penny stocks of yesteryear
Stock Horizon LLC
29 May 15 06:39:43
$DCTH hit 2nd predicted LONG move $1.76. On watch @ 09:00, alerted @ 09:32 & $1.51. http://t.co/Va8wI9xfT1
Stock Horizon LLC
29 May 15 06:39:16
$DCTH triggered LONG, hit 1st predicted LONG move $1.69. On watch @ 09:00, alerted @ 09:32 & $1.51. http://t.co/Va8wI9xfT1
SuperNova
29 May 15 06:38:47
$DCTH rallying on positive data with Delath's CHEMOSAT- up 45% at 1.70, strong resistance at $2 http://t.co/UMdIUiZKkj
PennyPRO.com
29 May 15 06:38:47
$DCTH rallying on positive data with Delath's CHEMOSAT- up 45% at 1.70, strong resistance at $2 http://t.co/jqk03wihtw
lookn4wins
29 May 15 06:37:39
GDX Market Vectors Gold Miners Shares http://t.co/b5XDsFIeAP $GDX $DCTH $JDST $FXE #GDX #invest #pennystocks
Jake13
29 May 15 06:37:27
FRO Frontline Ltd. Stock Forum http://t.co/wR7imqQQtk $FRO $AMRN $DCTH $JO #FRO #pennystocks #pennystocks
Stock Forums
29 May 15 06:37:26
GDXJ Market Vectors Junior Gold Miners Tick http://t.co/qv89wntOR4 $GDXJ $BVN $EDV $DCTH #GDXJ #investing #pennystocks
Emylers
29 May 15 06:37:23
FEYE FireEye Inc. P/E Ratio http://t.co/ykhAP8om30 $FEYE $DCTH $IWM $TLT #FEYE #finance #stockmarket
PennyStocksPAYD
29 May 15 06:37:01
Obviosly the strategy here was buy premarket $TBIO or $DCTH and sell the open
Hot Penny Stocks
29 May 15 06:36:27
RT @BioRunUp: $DCTH is on crack
HotStockAlert $PKGM$
29 May 15 06:36:17
i_like_bb_stock: $DCTH out 1.62 from 1.29 http://t.co/0vKEL9hLzc
DayTraderChoice
29 May 15 06:36:08
i_like_bb_stock: $DCTH out 1.62 from 1.29 http://t.co/NICFaVjUCb
IH NASDAQ OMX
29 May 15 06:36:07
DCTH Delcath Systems, Inc. P/E Ratio http://t.co/tPTkqPv3xk $DCTH $TSLA $XOMA $AA #DCTH #share #pennystocks
Stock Forums
29 May 15 06:35:51
DCTH Delcath Systems, Inc. Ask http://t.co/2pq8Oftz2b $DCTH $BSX $NUGT $INTC #DCTH #stockmarket #share
				
				
By  +Follow October 2, 2013 7:28AM
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