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 as a contributor and get eyeballs on your content FOR FREE!

Results for DCTH
Stockaholics
25 Nov 14 10:57:43
Our Platinum Penny Stock Pick On $STTK Is Up Over 128% This Morning. Huge News: http://t.co/MHaHGSIsXk $FTNT $DCTH $SHLM
Penny Stock Secret
25 Nov 14 09:33:27
This �Millionaire Maker� For Traders Shares His Secrets! Click here http://t.co/SVqoMlijqL .. $FTNT $DCTH $SHLM
chartguy89
25 Nov 14 07:34:22
DCTH 1.2601 Stock Charts $DCTH Delcath Systems Inc. (NASDAQ) Last Updated: 11/25/2014 09:34:25 DCTH Stock Char http://t.co/xjLGCd1rmx
Stockaholics
24 Nov 14 10:55:04
578% Gains On Penny Stocks in one month! Plus a New Pick Is Coming: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Penny Stock Secret
24 Nov 14 10:16:14
Premium Alerts Ranked #1 For Gains 2534% Last Week http://t.co/SVqoMlijqL .. $FTNT $DCTH $SHLM
Analyst Ratings
24 Nov 14 05:34:16
Get the latest ratings for $CVG $CYTR $DAR $TRAK $DCTH in your inbox with ARN Daily http://t.co/nSJuDtP5Bv
Stockaholics
23 Nov 14 18:27:25
578% Gains On Penny Stocks in one month! Plus a New Pick Is Coming: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Stockaholics
22 Nov 14 01:02:41
578% Gains On Penny Stocks in one month! Plus a New Pick Is Coming: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Stockaholics
21 Nov 14 17:17:51
578% Gains On Penny Stocks in one month! Plus a New Pick Is Coming: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Stockaholics
21 Nov 14 11:18:06
578% Gains On Penny Stocks in one month! Plus a New Pick Is Coming: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
chartguy89
21 Nov 14 07:24:44
DCTH 1.454 Stock Charts $DCTH Delcath Systems Inc. (NASDAQ) Last Updated: 11/21/2014 09:24:48 DCTH Stock Chart http://t.co/qcKQLr7DDt
Daily Contracts
21 Nov 14 06:20:02
Real-Time feed of company contracts, original agreements and executive updates from Delcath Systems $DCTH http://t.co/Pzn5QtpgaU
Penny Stock Secret
21 Nov 14 06:15:26
The Most Accurate Penny Stock Alert Service Made $54,000 Yesterday Click here http://t.co/SVqoMlijqL .. $FTNT $DCTH $SHLM
Stockaholics
20 Nov 14 23:49:54
578% Gains On Penny Stocks in one month! Plus a New Pick Is Coming: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Stockaholics
20 Nov 14 11:46:21
578% Gains On Penny Stocks in one month! Plus a New Pick Is Coming: http://t.co/2W3yKD2d5Q $FTNT $DCTH $SHLM
Penny Stock Secret
20 Nov 14 07:50:30
This �Millionaire Maker� For Traders Shares His Secrets! Click here http://t.co/SVqoMlijqL .. $FTNT $DCTH $SHLM
DailyStockPicks
19 Nov 14 21:19:49
$CYNAF $CTH.V rose 17% today on positive Phase 2 data. $2.75 target. http://t.co/5Vy1M3qBcv http://t.co/v3jMrkb9LH $DSCI $DCTH $ELOS $AHPI
Stockaholics
19 Nov 14 19:02:32
$CJTF closed up 128.57% Yesterday! New Pick Coming This Week: http://t.co/TOww1JMOlD $FTNT $DCTH $SHLM
Stockaholics
19 Nov 14 10:35:07
$CJTF closed up 128.57% Yesterday! New Pick Coming This Week: http://t.co/TOww1JMOlD $FTNT $DCTH $SHLM
doebop
18 Nov 14 19:16:30
RT @Stockaholics: $FONU was yesterdays top penny stock! Plus, $MHYS was just announced as our own new pick: http://t.co/W1dUG8Ww2F $FTNT $D…
Stockaholics
18 Nov 14 17:50:14
$FONU was yesterdays top penny stock! Plus, $MHYS was just announced as our own new pick: http://t.co/W1dUG8Ww2F $FTNT $DCTH $SHLM
4-traders.com
18 Nov 14 14:10:10
DELCATH SYSTEMS : Regulation FD Disclosure, Financial Statements and Exhibits (form 8-K) http://t.co/Hljw3VDwdY $DCTH
StockNews
18 Nov 14 14:09:14
$DCTH - Current Report Filing (8-k) http://t.co/LvAAUu02g0
Pzaa...Guy
18 Nov 14 14:09:08
$DCTH - Current Report Filing (8-k) http://t.co/V6SZgOsPLI
Stocks News&Markets
18 Nov 14 14:07:13
$DCTH - Current Report Filing (8-k) http://t.co/AgiWSihuyA
BV Healthcare
18 Nov 14 13:07:04
$DCTH Delcath Systems, Inc files Form 8-K (Events or Changes Between Quarterly Reports) SEC Filing.. http://t.co/krpziObwgG
Stockaholics
18 Nov 14 11:40:46
$FONU was yesterdays top penny stock! Plus, $MHYS was just announced as our own new pick: http://t.co/W1dUG8Ww2F $FTNT $DCTH $SHLM
Bruno Ferraz
18 Nov 14 10:26:41
$DCTH It's time for a move. DCTH as 10M more in cash that it as in market cap. It's got to go up or something is wrong with this market.
Daily Contracts
18 Nov 14 09:16:02
Real-Time feed of company contracts, original agreements and executive updates from Delcath Systems $DCTH http://t.co/Pzn5QtpgaU
Penny Stock Secret
18 Nov 14 04:14:57
Yesterday We Made $89,000 In Just One Trade More Info Here http://t.co/8BoYC1bsiz .. $DCTH $MSBF $VIAS
Stockaholics
18 Nov 14 04:01:53
$FONU was the top penny stock of the day yesterday! Plus, a new pick coming today: http://t.co/UDHJIasKws $FTNT $DCTH $SHLM
Stockaholics
17 Nov 14 19:46:44
New Penny Stock Pick Coming Tomorrow! Multi-Site Release, Going To Our members first: http://t.co/e8b0jnUMkC $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.