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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.

Results for DCTH
MarketNews
17 Apr 14 14:55:03
$DCTH - ABIOMEDs Impella RP Bags CE Mark -> http://t.co/CKbZgnk8VY #stock #stocks #stockaction
Mr. Wall Street
17 Apr 14 10:36:16
$DCTH Confirmed** people start realizing how this piece of junk is not worth their investment called few days ago see you to bottom
Mr. Wall Street
17 Apr 14 07:59:52
$DCTH close to trigger short alert on close watch
Wayne Nguyen
17 Apr 14 07:56:04
$DCTH Above blue trend line increases likelihood of seeing price above 4.5 http://t.co/ey8Eiy26C7
Antonio Costa
17 Apr 14 06:34:30
$DCTH pop
Wayne Nguyen
17 Apr 14 04:25:15
$DCTH After R/S it's low float and high percent short & combining w double bottom formation. A high succesful rate for short squeeze.
Antonio Costa
16 Apr 14 14:23:59
Stocks to Watch for April 17, 2014 http://t.co/ei8Do4quFz $AOL $DCTH $PDCE $WHR
Dollar$mell
16 Apr 14 12:36:57
RT @ACInvestorBlog: $DCTH holding overnight. I see a potential double bottom forming.
Antonio Costa
16 Apr 14 12:29:58
$DCTH holding overnight. I see a potential double bottom forming.
Mr. Wall Street
16 Apr 14 10:39:35
@HowardKech and for $DCTH same thing I am waiting for a PR pump manipulation hopefully they will push up to 4.5 and then I will short it
Wayne Nguyen
16 Apr 14 09:42:40
$DCTH Could see 4 by close
Antonio Costa
16 Apr 14 09:35:41
Long $DCTH 3.83
Wayne Nguyen
15 Apr 14 10:15:56
$DCTH Added long position here
YBE
15 Apr 14 09:49:36
K9: $Csco $Qcom $Dcth EBLs' Gd time to seek bargains on micro/small arises!! U5 The EBLs' battle vid: http://t.co/ouZiBgXPfz
Mr. Wall Street
15 Apr 14 07:39:28
$DCTH now should start to slowly go back to where it belong less than a 1$
Day Trade Alerts
15 Apr 14 07:39:20
via #AlertTrade SHORT Seller Alert $DCTH - DELCATH SYSTEMS #ShortSeller #Stocks http://t.co/VS8RO0UwVJ
Mattias Hertz
14 Apr 14 15:09:06
$DCTH: Balanced View of Luminex Corporation http://t.co/ENyKTlrKlH
Stock News 24
14 Apr 14 14:49:19
$DCTH - Balanced View of Luminex Corporation -> http://t.co/aMsW5dazyE #stock #stocks #stockaction
ChartMill
14 Apr 14 08:59:03
http://t.co/3qt3ey62ZF #stocks large players are selling $DCTH $CCE $WEN
Byrne Bray
14 Apr 14 04:14:04
$DCTH: Weakness Seen in AngioDynamics (ANGO): Stock Tumbles 7.8% http://t.co/K0jbR1nwJI
LoveStockNews
14 Apr 14 04:12:34
$DCTH - Weakness Seen in AngioDynamics (ANGO): Stock Tumbles 7.8% -> http://t.co/BkSSAyaPpZ #stock #stocks #stockaction
BioInvestor
13 Apr 14 15:10:22
Sure 500% with $OXGN Langercker notes partnership, Discus has also begun !! $ATRS $INCY $RNN $VICL $CTIC $BIOD $DCTH $ISIS $QCOR
Tony Friedman
12 Apr 14 14:01:02
Owning $DCTH after the RS is "suicide by stock" http://t.co/PE4TmwzmRz
Mr. Wall Street
11 Apr 14 13:03:11
Ok covered my short before weekend on $DCTH still holding my position on $RCON still green there for me
Mr. Wall Street
11 Apr 14 12:26:29
$DCTH still holding my short stress free more people will learn the company and their finance more it will drop
BioInvestor
11 Apr 14 10:30:06
Oxigene inc Langercker notes partnership, Discus has also begun !! $ATRS $DNDN $INCY $RNN $VICL $CTIC $BIOD $MNKD $DCTH $ISIS $QCOR
David Huete
11 Apr 14 07:40:06
$XGTI $DCTH $FB $AA $AAPL many buying the dip http://t.co/FBj0Lpo1T8
Cactus Trading
11 Apr 14 07:20:22
RT @Wallstreetking1: $DCTH only 2000 shares up over 700$ in 20 mins see you back @ 1 $ I give it 2 weeks
YBE
11 Apr 14 07:01:36
K9:$Csco $Qcom $Dcth EBLs' EBLs' Legions,anything u5 a great deal b4 any news!! NP!! GLTA!! The EBLs' battle vid: http://t.co/ouZiBgXPfz
Mr. Wall Street
11 Apr 14 06:55:07
$DCTH only 2000 shares up over 700$ in 20 mins see you back @ 1 $ I give it 2 weeks
MONSTER TRADES
11 Apr 14 06:38:16
RT @NerdElert: @MykeCorleone ... really nice job on $DCTH today btw
Leopoldo Sanchez
11 Apr 14 06:05:29
$ZGNX $VMEM $URRE $TVIX $TC $SPCB $RTK $ETRM $DNN $DCTH comments-->http://t.co/FiGWLJfoiO be careful out there guys
LoveStockNews
11 Apr 14 04:12:19
$DCTH - Delcath Systems (DCTH) Worth Watching: Stock Soars 20.1% -> http://t.co/nMSRQW8WVm #stock #stocks #stockaction
Stock Status
10 Apr 14 20:43:36
$DCTH nice 20% gain although it dropped a little in the after-hour market http://t.co/I66GnMxWCK
RichJr
10 Apr 14 17:18:21
@MykeCorleone ... really nice job on $DCTH today btw
Stock Signaling
10 Apr 14 16:31:07
Top Stocks (By Trading Liquidity): $CALL $BLOX $DECK $KBH $BZH $LIVE $MEET $WMC $VJET $YOKU $MNKD $NXST $ZGNX $DCTH $PANW #markets #nasdaq
MONSTER TRADES
10 Apr 14 15:13:04
WOW, i didnt think i'd have such a perfect exit on $DCTH. I sold at 4.48, 1cent off the HOD. I alerted everyone in supertrades chat.
Eli Pritsker
10 Apr 14 15:10:51
RT @carpetscott: Up today $IAG $SYN $HART $GOGO $AVP $HPQ $ETRM $EDZ $DCTH $GNK $BIS $GNCA $WATT $MCD $ORMP
Scott Thomas
10 Apr 14 14:03:05
Up today $IAG $SYN $HART $GOGO $AVP $HPQ $ETRM $EDZ $DCTH $GNK $BIS $GNCA $WATT $MCD $ORMP
Mr. Wall Street
10 Apr 14 13:52:26
$DCTH crashing after hours $RCON holding strong today still green there as well
				
				
By  +Follow October 2, 2013 7:28AM
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