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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.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions.


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Results for DCTH
FonsieTrader
18 Sep 14 04:39:46
Parabolic Sar Sell Signals 1/3 $ADS $AWF $BAX $BERY $BXS $CAH $CATY $CBRL $CHMT $COT $CSOD $CVBF $DCTH $DNKN $DRRX http://t.co/pa2jkgFpaR
iHangout
18 Sep 14 01:37:31
http://t.co/l4qmOlz0qf chartguy89: Stock Charts: DCTH 2.48 Stock Charts $DCTH Delcath Systems Inc. http://t.co/gELMNXyr7F
Stock Rocket
18 Sep 14 01:35:08
$NETE Gained 551.93% In The Past 6 Weeks! Major News: http://t.co/PU7GW934W5 $FTNT $DCTH $SHLM
Investors Hangout
18 Sep 14 01:34:37
chartguy89: DCTH 2.48 Stock Charts $DCTH Delcath Systems Inc. http://t.co/0pgKeSlBJB
Investors Hangout
18 Sep 14 01:34:37
chartguy89: DCTH 2.48 Stock Charts $DCTH Delcath Systems Inc. http://t.co/D6LW3GxGlY
chartguy89
18 Sep 14 01:31:51
DCTH 2.48 Stock Charts $DCTH Delcath Systems Inc. (NASDAQ) Last Updated: 09/18/2014 03:31:58 DCTH Stock Chart http://t.co/iU5D5n5DTn
Stock Rocket
17 Sep 14 21:32:17
$NETE Gained 551.93% In The Past 6 Weeks! Major News: http://t.co/PU7GW934W5 $FTNT $DCTH $SHLM
: ) MrsGAttitude : )
17 Sep 14 19:27:54
RT @theflynews: $DCTH Linkedto says $3 per share bid for Delcath Systems dropped: Full Story http://t.co/XgVFVe9pNr
: ) MrsGAttitude : )
17 Sep 14 19:27:44
RT @MarketCurrents: Shareholder drops bid for DelCath http://t.co/F5N3FbZqlb $DCTH
Stock Rocket
17 Sep 14 14:37:55
$NETE Gained 551.93% In The Past 6 Weeks! Major News: http://t.co/h5N34SPJ6o $FTNT $DCTH $SHLM
8675309
17 Sep 14 14:09:03
This companys board looks worse than this $DCTH - the stank of them in unbearable http://t.co/sZSxbppafU
MarketCurrents
17 Sep 14 10:38:04
Shareholder drops bid for DelCath http://t.co/F5N3FbZqlb $DCTH
Bio Stocks™
17 Sep 14 10:14:03
'We have also sold all our shares upon discovering how truly dysfunctional this company and its board truly are.' Linkedto $DCTH // LOL!
Adam Gefvert, CFA
17 Sep 14 10:09:56
$DCTH, $3 bid dropped from Linkedto partners.
BeatTheStreet
17 Sep 14 10:07:18
$DCTH Linkedto dropped $3 per share bid for Delcath Systems
Amit Gupta
17 Sep 14 10:05:36
RT @theflynews: $DCTH Linkedto says $3 per share bid for Delcath Systems dropped: Full Story http://t.co/XgVFVe9pNr
The Fly
17 Sep 14 10:05:14
$DCTH Linkedto says $3 per share bid for Delcath Systems dropped: Full Story http://t.co/XgVFVe9pNr
Don Looney
17 Sep 14 09:48:45
Bags i'm holding, $ISNS, $MNKD, $WIX, $HSOL, $ANR, $DCTH, and some that may turn. Hohum...beer cold yet?
Stockaholics
17 Sep 14 00:38:38
Our Platinum Penny Stock Picks, Gained 90% In The Past 2 Days! Get our next pick early: http://t.co/hep0lGZUgZ $FTNT $DCTH $SHLM
BuyersStrike
16 Sep 14 21:12:26
. @NathanAhron $DCTH: Once a Whale bucket shop unit offering, always a Whale bucket shop deal....
NathanAaron
16 Sep 14 20:09:34
$dcth paying their chairman $120k annually. That is beyond ridiculous...
Stockaholics
16 Sep 14 13:30:45
$BRNW Ran Up 145% So Far Today! Huge News: http://t.co/agBJ7Ngnzq $FTNT $DCTH $SHLM
WallStreet
16 Sep 14 08:51:08
Wall Street Digest: $PRPH, $DCTH, $AKG, $BIOL - - http://t.co/jlgebD1rbV
Antonio Costa
16 Sep 14 07:58:51
$DCTH bounces...... squeeze potential over 2.76
FonsieTrader
16 Sep 14 07:45:06
$DCTH moving
SMA
16 Sep 14 06:50:02
Penny stock $DCTH High Positive S-Score Sep 16, 9:49 AM ET, chart at http://t.co/TXMxU7bVPs #trading #stock #PennyStock
Jose llerena
16 Sep 14 06:00:25
$DCTH 2.76 key level to watch.
Antonio Costa
16 Sep 14 05:49:19
Some serious upside volume coming into $DCTH If It breaks above 2.76, we can run to 3.53 easily http://t.co/Xrayb6Lkav
Stockaholics
15 Sep 14 21:50:27
Our SECRET Alert on $INOH Closed Up 60% For Platinum Members Today! Major News: https://t.co/HzD6J3YtmW $FTNT $DCTH $SHLM
Joey Joe Joe Junior
15 Sep 14 19:51:07
over a dollar for tomorrow... $ACST $PVCT $ETAK $DNDN $AAU $CTIX $NVTL $BIOL $DCTH $CHYR $ASTY $SINO $ELON $TVIX
Antonio Costa
15 Sep 14 14:52:30
Stocks to Watch for September 16, 2014 http://t.co/sDWkukNMr3 $BK $DCTH $EA $MEIP $USEL
StockNews
15 Sep 14 14:27:24
$DCTH - Statement of Changes in Beneficial Ownership (4) http://t.co/Ngk2LIPlhC
Pzaa...Guy
15 Sep 14 14:27:20
$DCTH - Statement of Changes in Beneficial Ownership (4) http://t.co/YKSUSoBNOW
VisualStock Resource
15 Sep 14 14:27:14
$DCTH - Statement of Changes in Beneficial Ownership (4) http://t.co/RukZOPbzD6
MarketCurrents
15 Sep 14 14:17:08
Management shuffle at Delcath http://t.co/VSzBfnKuDh $DCTH
4-traders.com
15 Sep 14 14:10:08
DELCATH SYSTEMS : Change in Directors or Principal Officers (form 8-K) http://t.co/Uwoic9PubZ $DCTH
StockNews
15 Sep 14 14:08:30
$DCTH - Current Report Filing (8-k) http://t.co/vUnQqEVCoe
Pzaa...Guy
15 Sep 14 14:08:23
$DCTH - Current Report Filing (8-k) http://t.co/xylnBm9vS7
VisualStock Resource
15 Sep 14 14:08:18
$DCTH - Current Report Filing (8-k) http://t.co/P8W0e749mt
BV Healthcare
15 Sep 14 14:07:12
$DCTH Delcath Systems, Inc files Form 8-K (Events or Changes Between Quarterly Reports) SEC Filing.. http://t.co/otxw2QoO1q
PlungeProtectionTeam
15 Sep 14 13:49:42
RT @upstocks13: Latest trades $AVNR $OTIV $DCTH $UVXY http://t.co/Fne4XpRIrF
microcaptrader
15 Sep 14 13:41:50
RT @upstocks13: Latest trades $AVNR $OTIV $DCTH $UVXY http://t.co/Fne4XpRIrF
microcaptrader
15 Sep 14 13:41:47
RT @upstocks13: UPstocks weekly newsletter $SPY $UVXY $QQQ $DCTH $STV $OTIV $DRL http://t.co/JnunPF4juc
aziz saba
15 Sep 14 13:39:24
Latest trades $AVNR $OTIV $DCTH $UVXY http://t.co/Fne4XpRIrF
aziz saba
15 Sep 14 13:38:47
UPstocks weekly newsletter $SPY $UVXY $QQQ $DCTH $STV $OTIV $DRL http://t.co/JnunPF4juc
Antonio Costa
15 Sep 14 12:33:23
$AVNR $AVEO $DCTH $USEL holding overnight
Eternity101
15 Sep 14 12:18:31
RT @Lizardjb3: @Eternity100000 $DCTH Don't play that cheap, however it look as if it's going to blow to the up side ... Have a look. http:/…
James F Bowen III
15 Sep 14 12:17:08
RT @Eternity100000: @Lizardjb3 also -- try $DCTH - low float & was alerted by someone down my stream -- it's volume 2day is 10x -- so maybe…
James F Bowen III
15 Sep 14 12:15:19
@Eternity100000 $DCTH Don't play that cheap, however it look as if it's going to blow to the up side ... Have a look. http://t.co/REiqgJLJzK
1 TRADER
15 Sep 14 12:09:23
Bought 1/3 position in $DCTH 2.69 ST ovnt
				
				
By  +Follow October 2, 2013 7:28AM
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