logo  
Sign in or Register

Already a member?

Sign in

Or sign in with your account on:

Not a member yet?

Register
    

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

By  +Follow October 2, 2013 7:28AM
Share:
Tickers Mentioned:

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.


Liked What You Read? Join Equities.com and Connect With Your Favorite Financial Experts FOR FREE! Members of Equities.com gain access to our leading financial news and content, active social investment community, proprietary research tools including the 2014 Small-Cap Stars, E.V.A. reports and more.

Results for DCTH
Pete Stock
31 Oct 14 12:47:53
Remember the $PLX $4 tgt well forget about it or $DCTH 2.25 forget about it or $BGMD .75 forget about it, $AVEO 1.25, nope $ABIO 1.40 nope
Jon Vince
31 Oct 14 10:25:48
Dumped non-runner $DCTH with just enuff to pay broker and buy some Halloween candy
Stockaholics
31 Oct 14 09:50:54
Our Penny Stock Newsletter Alert On MGON Closed up 112.5% Today! Major News: http://t.co/dvxYQnSJab $FTNT $DCTH $SHLM
Penny Stock Secret
31 Oct 14 07:14:17
The Hottest Way to Make Millions From Stock Market.Click HERE http://t.co/SVqoMkrw2z .. $FTNT $DCTH $SHLM
Stockaholics
31 Oct 14 02:04:18
Our Penny Stock Newsletter Alert On MGON Closed up 112.5% Today! Major News: http://t.co/gDCrqEFOy6 $FTNT $DCTH $SHLM
Stockaholics
30 Oct 14 20:33:18
Our Penny Stock Newsletter Alert On MGON Closed up 112.5% Today! Major News: http://t.co/dvxYQnSJab $FTNT $DCTH $SHLM
Daily Contracts
30 Oct 14 11:56:01
Real-Time feed of company contracts, original agreements and executive updates from Delcath Systems $DCTH http://t.co/7xYeoBI3dD
Stockaholics
30 Oct 14 10:31:59
VIICQ Closed up 75% Yesterday! Special Update: http://t.co/8A33lxh1RR $FTNT $DCTH $SHLM
Stockaholics
29 Oct 14 23:58:41
$MLCG closed up 166.67% today! Huge News: http://t.co/JxSMla9Afn $FTNT $DCTH $SHLM
Stockaholics
29 Oct 14 19:56:31
$MLCG closed up 166.67% today! Huge News: http://t.co/JxSMla9Afn $FTNT $DCTH $SHLM
BV Healthcare
29 Oct 14 13:12:02
$DCTH DELCATH TO REPORT THIRD QUARTER 2014 RESULTS ON NOVEMBER 5, 2014.. http://t.co/oexp9YaABe
Stockaholics
29 Oct 14 12:18:04
Subscribe to our Penny Stock Newsletter, for the best penny stock picks, for FREE: http://t.co/5DC8vbG515 $FTNT $DCTH $SHLM
Stockaholics
28 Oct 14 23:24:10
After 371% Gains Our New Penny Stock Pick Is Coming Tomorrow! Get It Early: http://t.co/Nmnx36zJMR $FTNT $DCTH $SHLM
Bruno Ferraz
28 Oct 14 13:51:56
$DCTH So strong in some parts of the day and closes so badly. A bit of disappointment.
Diplomatic Immunity
28 Oct 14 13:10:22
Best advice you'll get today: STAY AWAY FROM $DCTH as @buysellshort is pumping it yet again. It NEVER goes up. Sell and block buysellshit.
pete doom
28 Oct 14 13:08:21
Tomorrow I'm watching $Powr $DCTH $GENE $GBLX Have a beautiful evening!
Christian
28 Oct 14 11:17:38
RT @buysellshort: $DCTH - SharpCharts Workbench - http://t.co/bQDH8Jygz4 http://t.co/0f1KXLzsuF
Alex
28 Oct 14 11:17:14
RT @buysellshort: $DCTH $2.90 cash per share, low float and positive data tomorrow and chart ripe for large move
pete doom
28 Oct 14 09:20:50
RT @FastlaneFurious: LEADING CANCER CENTERS TO PRESENT DATA FROM DELCATH'S CHEMOSAT/MELPHALAN HDS AT ESSO CONGRESS [Thomson $ONE $DCTH ht…
Fa$tlane $tocks
28 Oct 14 09:10:32
LEADING CANCER CENTERS TO PRESENT DATA FROM DELCATH'S CHEMOSAT/MELPHALAN HDS AT ESSO CONGRESS [Thomson $ONE $DCTH http://t.co/T0UDnG3ZEa
moderneconomist.com
28 Oct 14 08:46:48
RT @tymorapro: $DCTH: 1mRunaway+:2 [+7%,1.6%offHi], tf:0111111, FirmTrnd--:+100%; TrdVol:11x:21x; TLM:1.4; ILM:0.7, 1WkHi+, DyVol:341T:12.4…
Alexander Morris
28 Oct 14 08:44:05
$DCTH: 1mRunaway+:2 [+7%,1.6%offHi], tf:0111111, FirmTrnd--:+100%; TrdVol:11x:21x; TLM:1.4; ILM:0.7, 1WkHi+, DyVol:341T:12.4x:7.4x
RichJr
28 Oct 14 08:41:19
$DCTH new highs
justamoneymatter
28 Oct 14 08:36:04
$DCTH on watch
pete doom
28 Oct 14 08:21:56
@nickelwurld $DCTH http://t.co/Sl2npXhtnx
Jon Vince
28 Oct 14 07:41:41
$DCTH up in high volume on Cancer Center Congress announcement.
Pete Stock
28 Oct 14 07:37:09
off hand on cash rich I have 3 $KBIO $AVEO $DCTH im probably leaving more
Pete Stock
28 Oct 14 07:36:07
10 days ago $OXGN moved from 1.80 entries hence $DCTH comparison. Now that $OXGN pop 2.40 $DCTH shd test low 2s imo, noise level increased
Pete Stock
28 Oct 14 07:32:18
10d ago, day 1 RT On my small bios list most are gone from lows one exception $DCTH 1.75 from 1.70, I see at least 1.90s. $OXGN type of move
buysellshort.net
28 Oct 14 07:28:58
@PeteStock11 a nice chart low float 40% under cash and history of big moves, a lot to like on $DCTH
Pete Stock
28 Oct 14 07:26:22
Nice of you to join RT @buysellshort: $DCTH $2.90 cash per share, low float and positive data tomorrow and chart ripe for large move
buysellshort.net
28 Oct 14 07:25:34
$DCTH $2.90 cash per share, low float and positive data tomorrow and chart ripe for large move
buysellshort.net
28 Oct 14 07:25:01
$DCTH - SharpCharts Workbench - http://t.co/bQDH8Jygz4 http://t.co/0f1KXLzsuF
usasingh11
28 Oct 14 07:21:58
$DCTH Data coming tomorrow. keep radar Sir http://t.co/FbZwR7kN3Q could move big if positive data
usasingh11
28 Oct 14 07:20:48
$DCTH cash per share $2.67 and trading 1.80 ? http://t.co/m4Mk6F7xwh @jimcramer
Alexander Morris
28 Oct 14 07:18:03
$DCTH: 1mRunaway+:1 [+5%,1.6%offHi], 3mMv:+3, 3:1Accel+, tf:0111111, FirmTrnd--:+100%; TrdVol:9x:33x; TLM:1.1; ILM:0.6, 1WkHi+
HE-MAN
28 Oct 14 07:17:31
$DCTH vol
RichJr
28 Oct 14 07:17:13
getting very long $DCTH here ... monsta move coming %-wise imo
Mr.Incredible
28 Oct 14 07:12:01
$DCTH low float Drug Delivery stock on watch - Potential for $2+ http://t.co/dSLtRt6wzk
Stockaholics
28 Oct 14 06:59:16
After 371% Gains A Major New Penny Stock Pick Is Coming: http://t.co/1aBeBJdWkA $FTNT $DCTH $SHLM
wininstocks2014
28 Oct 14 04:57:16
DCTH 1.72 Stock Charts $DCTH Delcath Systems Inc. (NASDAQ) Last Updated: 10/28/2014 06:57:19 DCTH Stock Chart http://t.co/XjVX1wCG3Z
BV Healthcare
28 Oct 14 04:02:55
$DCTH LEADING CANCER CENTERS TO PRESENT DATA FROM DELCATH'S CHEMOSAT/MELPHALAN HDS AT ESSO CONGRESS.. http://t.co/pfva57XQkG
Daily Contracts
27 Oct 14 13:44:02
Real-Time feed of company contracts, original agreements and executive updates from Delcath Systems $DCTH http://t.co/7xYeoBI3dD
Stockaholics
27 Oct 14 11:01:47
371% Gains And A New Penny Stock Pick Is Coming Today! Get It Early: https://t.co/jbhQATzxpj $FTNT $DCTH $SHLM
Stock Relay
25 Oct 14 23:34:10
wininstocks2014: Stock Charts: DCTH 1.74 Stock Charts $DCTH Delcath Systems Inc. http://t.co/cBMH9fZal5
wininstocks2014
25 Oct 14 23:32:30
DCTH 1.74 Stock Charts $DCTH Delcath Systems Inc. (NASDAQ) Last Updated: 10/26/2014 01:32:29 DCTH Stock Chart http://t.co/oNe8O5CSbT
Stockaholics
25 Oct 14 14:34:46
Our Penny Stock Alerts Gained 371% In 2 weeks! Sign Up For Free Text Alerts For Our New Pick: http://t.co/dLDRavoCi4 $FTNT $DCTH $SHLM
Stockaholics
25 Oct 14 11:37:04
Our Penny Stock Alerts Gained 371% In 2 weeks! Sign Up For Free Text Alerts For Our New Pick: http://t.co/dLDRavoCi4 $FTNT $DCTH $SHLM
Patrick
25 Oct 14 05:44:55
Why does someone want to buyout $DCTH??? http://t.co/ynYlFFiroY
Stockaholics
24 Oct 14 13:19:08
Our Penny Stock Alerts Gained 371% In 2 weeks! Sign Up For Free Text Alerts For Our New Pick: http://t.co/dLDRavoCi4 $FTNT $DCTH $SHLM
				
				
By  +Follow October 2, 2013 7:28AM
Share:

Comments

 

blog comments powered by Disqus

About us

Equities.com is the most advanced interactive online social ecosystem for the financial industry, serving as a resource center and next-generation communication platform that connects self-directed investors with public issuers, market experts, and professional service providers and vendors. Registered members can leverage our exclusive proprietary research tools such as the Small-Cap Stars, which outperformed 90% of all small-cap mutual funds, and robust do-it-yourself E.V.A. research reports. The Equities.com Issuer Dashboard is the ideal tool to communicate and manage investor awareness campaigns to the investment community, as well as to access valuable resources to help your company grow.

Market Data powered by QuoteMedia.
Copyright © QuoteMedia. Data delayed 15 minutes unless otherwise indicated. Terms of Use.