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
Stockaholics
20 Dec 14 16:14:56
Platinum Memberships Rose, After 528% Gains On Penny Stocks, In One Month! Big Update: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Stockaholics
20 Dec 14 08:41:43
Platinum Memberships Rose, After 528% Gains On Penny Stocks, In One Month! Big Update: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Stockaholics
19 Dec 14 22:27:13
Platinum Memberships Rose, After 528% Gains On Penny Stocks, In One Month! Big Update: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Stockaholics
19 Dec 14 14:47:40
Platinum Memberships Rose, After 528% Gains On Penny Stocks, In One Month! Big Update: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Penny Stock Secret
19 Dec 14 07:23:30
Make Money With BitCoin Every Single Day More Info Here http://t.co/SVqoMlijqL .. $FTNT $DCTH $SHLM
whutrades
18 Dec 14 11:16:31
$DCTH chart; 50ma test - usually runs big Dec/Jan
Stockaholics
18 Dec 14 08:56:57
Platinum Memberships Rose, After 528% Gains On Penny Stocks, In One Month! Big Update: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Stockaholics
18 Dec 14 02:03:23
Platinum Memberships Rose, After 528% Gains On Penny Stocks, In One Month! Big Update: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Stockaholics
17 Dec 14 14:51:23
Platinum Memberships Rose, After 528% Gains On Penny Stocks, In One Month! Big Update: http://t.co/BuDJZVQmcq $FTNT $DCTH $SHLM
chartguy89
17 Dec 14 13:17:17
DCTH +0.75% Stock Charts $DCTH Delcath Systems Inc. (NASDAQ) Last Updated: 12/17/2014 15:17:15 DCTH Stock Char http://t.co/VnsWHIPs9H
Daily Contracts
17 Dec 14 12:55:01
Real-Time feed of company contracts, original agreements and executive updates from Delcath Systems $DCTH http://t.co/Pzn5QtpgaU
Penny Stock Secret
17 Dec 14 09:56:05
The Stock Picking Service of 2014 More Info Here http://t.co/SVqoMlijqL ... $FTNT $DCTH $SHLM
Stockaholics
17 Dec 14 07:00:53
Platinum Memberships Rose, After 528% Gains On Penny Stocks, In One Month! Big Update: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Fa$tlane $tocks
16 Dec 14 19:56:17
DELCATH STRENGTHENS BOARD OF DIRECTORS WITH NEW APPOINTMENTS | 6:02 AM | [Thomson Reuters ONE] $ONE $DCTH http://t.co/VscRh2DiT0
Stockaholics
16 Dec 14 14:21:27
Platinum Memberships Rose, After 528% Gains On Penny Stocks, In One Month! Big Update: http://t.co/BuDJZVQmcq $FTNT $DCTH $SHLM
StockNews
16 Dec 14 07:07:51
$DCTH - Statement of Changes in Beneficial Ownership (4) http://t.co/EWb9zVzyNa
Stocks News&Markets
16 Dec 14 07:07:46
$DCTH - Statement of Changes in Beneficial Ownership (4) http://t.co/30rheSAKQw
NASDAQ
16 Dec 14 07:07:43
$DCTH - Statement of Changes in Beneficial Ownership (4) http://t.co/uti36Q7tBR
StockNews
16 Dec 14 06:55:14
$DCTH - Initial Statement of Beneficial Ownership (3) http://t.co/LuCNnXSi3r
StockNews
16 Dec 14 06:52:17
$DCTH - Initial Statement of Beneficial Ownership (3) http://t.co/6apwgueCu7
Stocks News&Markets
16 Dec 14 06:52:13
$DCTH - Initial Statement of Beneficial Ownership (3) http://t.co/LXtD2MydG8
Talent4Boards
16 Dec 14 06:15:48
Delcath Systems appoints Dennis Langer, William Rueckert, Marco Taglietti to #BoardOfDirectors http://t.co/5oV84CW8e4 $DCTH #NonExec #pharma
StockNewsWires
16 Dec 14 02:19:03
$DCTH $HMY: Notable Stocks in Focus: Delcath Systems (NASDAQ:DCTH ... http://t.co/KYsePAjKPM http://t.co/VSatwJ5AQb
Stockaholics
16 Dec 14 00:06:20
Platinum Memberships Rose, After 528% Gains On Penny Stocks, In One Month! Big Update: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Stockaholics
15 Dec 14 20:06:25
Platinum Memberships Rose, After 528% Gains On Penny Stocks, In One Month! Big Update: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
MAISA
15 Dec 14 15:36:23
$DCTH announced the appointment of Dr. Dennis H. Langer, William D. Rueckert and Dr. Marco Taglietti to the Company’s Board of Directors
Stocks News&Markets
15 Dec 14 14:16:42
$DCTH - Statement of Changes in Beneficial Ownership (4) http://t.co/HUd1pSnuqQ
Stocks News&Markets
15 Dec 14 14:16:41
$DCTH - Initial Statement of Beneficial Ownership (3) http://t.co/DJea5h6gQ2
StockNews
15 Dec 14 14:16:33
$DCTH - Statement of Changes in Beneficial Ownership (4) http://t.co/0sGY5hsP5r
StockNews
15 Dec 14 14:16:32
$DCTH - Initial Statement of Beneficial Ownership (3) http://t.co/aVZnlEEhsa
StockNews
15 Dec 14 14:13:31
$DCTH - Initial Statement of Beneficial Ownership (3) http://t.co/Ig0bITvEwH
StockNews
15 Dec 14 14:13:30
$DCTH - Statement of Changes in Beneficial Ownership (4) http://t.co/oSRDiO6LNA
Stocks News&Markets
15 Dec 14 14:13:17
$DCTH - Initial Statement of Beneficial Ownership (3) http://t.co/PYaXBAVrjo
Stocks News&Markets
15 Dec 14 14:13:15
$DCTH - Statement of Changes in Beneficial Ownership (4) http://t.co/0bHWB19Qb3
Stockaholics
15 Dec 14 13:54:38
Platinum Memberships Rose, After 528% Gains On Penny Stocks, In One Month! Big Update: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
4-traders.com
15 Dec 14 13:35:13
DELCATH SYSTEMS : Change in Directors or Principal Officers, Financial Statements and Exhibits (form 8-K) http://t.co/PdQubSp4fr $DCTH
StockNews
15 Dec 14 13:34:12
$DCTH - Current Report Filing (8-k) http://t.co/MTb4vjwE6c
Stocks News&Markets
15 Dec 14 13:34:09
$DCTH - Current Report Filing (8-k) http://t.co/tV9NwBJ3WE
BV Healthcare
15 Dec 14 13:32:05
$DCTH Delcath Systems, Inc files Form 8-K (Events or Changes Between Quarterly Reports) SEC Filing.. http://t.co/7gd1GRhjKO
Bruno Ferraz
15 Dec 14 10:37:55
$DCTH At last... http://t.co/b4DS9AjLiu
Brian Riley
15 Dec 14 09:29:57
$DCTH 12% just started trading over the 10 day
Penny Stock Secret
15 Dec 14 08:03:45
The Stock Picking Service of 2014 More Info Here http://t.co/SVqoMlijqL .. $FTNT $DCTH $SHLM
ProVesting
15 Dec 14 06:23:02
$DCTH: Delcath Systems (DCTH) Adds Three New Directors http://t.co/RL6vXcB7WU http://t.co/2RTrGcCrZs
NASDAQ
15 Dec 14 04:05:13
$DCTH - DELCATH STRENGTHENS BOARD OF DIRECTORS WITH NEW APPOINTMENTS http://t.co/emruFcSgAa
4-traders.com
15 Dec 14 04:05:11
Delcath Systems : STRENGTHENS BOARD OF DIRECTORS WITH NEW APPOINTMENTS http://t.co/QZ1LKAPCtB $DCTH
Stockaholics
14 Dec 14 21:06:31
Platinum Memberships Rose, After 528% Gains On Penny Stocks, In One Month! Big Update: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Stockaholics
14 Dec 14 14:43:45
Platinum Memberships Rose, After 528% Gains On Penny Stocks, In One Month! Big Update: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Stockaholics
14 Dec 14 06:04:19
Platinum Memberships Rose, After 528% Gains On Penny Stocks, In One Month! Big Update: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Stockaholics
14 Dec 14 00:04:46
Platinum Memberships Rose, After 528% Gains On Penny Stocks, In One Month! Big Update: http://t.co/2W3yKD2d5Q $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.