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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
Momentum Stocks
2 Sep 14 14:07:47
$HPJ $DCTH $INUV $DCTH $DGLY nice day http://t.co/4jDfbd6C5P
RTA
2 Sep 14 13:25:24
out half of $DCTH @ 2.70 + .35
Neiman
2 Sep 14 13:21:37
$DCTH Activist investor: company worth $10-12 per share and is a buyout target. http://t.co/GvAzS2D4Cf Trading Below Cash Per Share
Companies in News
2 Sep 14 12:14:10
$DCTH: DELCATH SYSTEMS, INC. Files SEC form 10-Q, Quarterly Report http://t.co/FU10ArlVCU http://t.co/TJoMoGCS6l
Ankur Banerjee
2 Sep 14 11:47:37
RT @susanfoofoo: $DCTH Linkedto Partners, which owns 65.3K shares, issued a press release calling for sale. Linkedto believes Delcath could…
S Romberger
2 Sep 14 11:41:13
$DCTH Linkedto Partners, which owns 65.3K shares, issued a press release calling for sale. Linkedto believes Delcath could be worth $10-$12
Neiman
2 Sep 14 11:34:27
$DCTH Delcath Systems rallies after Linkedto calls for sale: Full Story http://t.co/3X71Hx02LZ
Neiman
2 Sep 14 11:34:23
http://t.co/IhEmZ4RlW9 $DCTH Activist Investor calls for sale of @dcth4f8f15a238
Neiman
2 Sep 14 11:33:52
RT @theflynews: $DCTH Delcath Systems rallies after Linkedto calls for sale: Full Story http://t.co/bWjHu1m5mj
Media Sentiment
2 Sep 14 11:04:57
$DCTH received a new alert. Find out why at http://t.co/5udYd0Ofs6 #stocks #daytrading #trading #mkt #NYSE #NASDAQ #markets 324
The Fly
2 Sep 14 11:04:13
$DCTH Delcath Systems rallies after Linkedto calls for sale: Full Story http://t.co/bWjHu1m5mj
Javier Restrepo
2 Sep 14 10:36:16
@Camiloagu $DCTH out @ 2.59 desde 2.3495. Buen tip! Gracias. http://t.co/1tvvQRbB64
Stocks in News
2 Sep 14 10:14:09
$DCTH: DELCATH SYSTEMS, INC. Files SEC form 8-K, Change in Directors or Principal Officers http://t.co/IEwOh0bCGL http://t.co/1YfPw0Nkbw
darrell Allen
2 Sep 14 09:50:37
Im gonna buy 5k $ADMP when its5.06. It looks like its going to run larger than $ISNS $DGLY $VGGL $IDI $INUV $ASTI $USU $DCTH $CNET $MSN $LEI
Market Headlines
2 Sep 14 09:14:10
$DCTH: DELCATH SYSTEMS, INC. Files SEC form 10-Q, Quarterly Report http://t.co/NgDuWRoVUO http://t.co/d8XwHdbxba
Antonio Costa
2 Sep 14 08:51:30
$DCTH nice profit...added few + Shares here of $NURO im waiting for the China news :) $DGLY insane !!
Antonio Costa
2 Sep 14 08:45:42
$DCTH sold all my Shares.... from 2.30 alert
RTA
2 Sep 14 08:43:07
$DCTH + 12%
Momentum Stocks
2 Sep 14 08:41:10
$DCTH took patience, but here we go
nyse.ru.com
1 Sep 14 20:28:58
#reshearch Sep 02 http://t.co/0c6HrbHnYW $DGLY $RSH $PRAN $WPCS $ZGNX $CAK $IVAN $ARO $FXEN $VHI $RXII $BDR $TOPS $DCTH $WTSL $PRKR $CREG
Stockaholics
1 Sep 14 17:44:49
$IWEB closed up 100% today, on more than 290 MILLION shares traded! Huge News: http://t.co/P7CLtdrz6f $FTNT $DCTH $SHLM
Daily Contracts
29 Aug 14 09:40:02
Real-Time feed of company contracts, original agreements and executive updates from Delcath Systems $DCTH http://t.co/7xYeoBI3dD
Stockaholics
28 Aug 14 15:57:10
$VIIC ran up 720% Today in an explosive move! Our new picks are coming soon: http://t.co/EdxLh9u5Nx $FTNT $DCTH $SHLM
Stock News Headlines
28 Aug 14 12:14:10
$DCTH: Most active Nasdaq-traded stocks http://t.co/XM5QTyWUd4 http://t.co/WNDfUJSL0K
Market Headlines
28 Aug 14 11:14:09
$DCTH: Delcath Systems (DCTH) Scheduled to Post Quarterly Earnings on Wednesday http://t.co/CKRj7t1LT8 http://t.co/DZNeFgMQQZ
Alex
28 Aug 14 11:03:02
$DARA buyers...check out $DCTH ... could rip big
Alex
28 Aug 14 11:01:27
$DCTH very bottom bio... better than $DARA $TKMR $GALT
Alex
28 Aug 14 10:58:18
RT @ACInvestorBlog: $DCTH If it breaks 2.38, we can run to $3 easily
Alex
28 Aug 14 10:57:51
RT @bman_alerts: Pull up $DCTH
RTA
28 Aug 14 07:43:40
I'm trading $DCTH today. In at 2.35
Жусупов Олег
28 Aug 14 06:20:02
$DCTH inerested
GPS
27 Aug 14 20:37:39
RT @bman_alerts: Pull up $DCTH
Eli Pritsker
27 Aug 14 20:24:08
RT @OhNo5000Bees: Thurs watch: $DCTH 2.50, $AEZS 1.36, $RENN 3.50, $RSH, $FOLD, $ETAK
OhNo5000Bees!
27 Aug 14 20:23:00
Thurs watch: $DCTH 2.50, $AEZS 1.36, $RENN 3.50, $RSH, $FOLD, $ETAK
Stock Market News
27 Aug 14 20:14:09
$DCTH: Delcath Systems Inc Earnings Call scheduled for 4:30 pm ET today http://t.co/VKra9wTE3y http://t.co/bLEOBsRaiK
Stephen M Richardson
27 Aug 14 20:08:47
RT @bman_alerts: Pull up $DCTH
Eli Pritsker
27 Aug 14 20:04:57
@bman_alerts I got some also but at 2.37 :(. $dcth
Eli Pritsker
27 Aug 14 20:03:53
RT @bman_alerts: Pull up $DCTH
StockTalk
27 Aug 14 20:00:26
Pull up $DCTH
Eli Pritsker
27 Aug 14 14:57:10
RT @KylanHodson: $DCTH thin but Hod threatened multiple day b.o with over 2.5 times daily volume http://t.co/IHYjd6XxGE
Trader_Penny_Stocks
27 Aug 14 14:36:40
RT @ACInvestorBlog: $DCTH If it breaks 2.38, we can run to $3 easily
Alex
27 Aug 14 14:33:24
$DCTH buyout ??? anytime soon ? well dailymail will come up with that soon too $TKMR
Tradingcol
27 Aug 14 13:59:12
@Camiloagu @amcno03 $DCTH la que ahora está en $ 2.39 ? o estan teniendo en cuenta el split.
Javier Restrepo
27 Aug 14 13:57:34
RT @Camiloagu: @amcno03 pendiente $DCTH
Kylan Hodson
27 Aug 14 13:33:40
$DCTH thin but Hod threatened multiple day b.o with over 2.5 times daily volume http://t.co/IHYjd6XxGE
StockTalk
27 Aug 14 13:23:37
$DCTH off last nights scan has that look
Business Headlines
27 Aug 14 13:14:09
$DCTH: Delcath Systems Inc To Raise Approximately $7.5 Million http://t.co/vBT0cFcm5S http://t.co/PSLc33Z7lK
Kylan Hodson
27 Aug 14 13:09:03
RT @ACInvestorBlog: $DCTH has a buyer ... volume already doubled.
Eli Pritsker
27 Aug 14 13:01:31
RT @MONEYEMPIRE: $DCTH not done yet :)
Eli Pritsker
27 Aug 14 13:01:26
RT @biotrader4gain: $DCTH setting up nicely with some eod buying
				
				
By  +Follow October 2, 2013 7:28AM
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