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 Oct 14 14:00:50
After Massive Gains On Penny Stock Picks, another New Pick Is Coming! Check it out: http://t.co/lWd4jUXeCy $FTNT $DCTH $SHLM
Stockaholics
20 Oct 14 01:28:59
After Massive Gains On Penny Stock Picks, another New Pick Is Coming! Check it out: http://t.co/lWd4jUXeCy $FTNT $DCTH $SHLM
Stockaholics
19 Oct 14 20:52:49
IBIO Closed Up 69.84% After Our Penny Stock Alert! New Picks Coming: http://t.co/OG2rloNNni $FTNT $DCTH $SHLM
4-traders.com
18 Oct 14 22:05:04
Delcath Systems : OTC Daily Alert Stock Watch - Delcath Systems, Inc. (NASDAQ: DCTH) http://t.co/mFxFH1OgJv $DCTH
Stockaholics
18 Oct 14 13:28:08
IBIO Closed Up 69.84% After Our Penny Stock Alert! New Picks Coming: http://t.co/OG2rloNNni $FTNT $DCTH $SHLM
Stockaholics
18 Oct 14 10:17:32
IBIO Closed Up 69.84% After Our Penny Stock Alert! New Picks Coming: http://t.co/OG2rloNNni $FTNT $DCTH $SHLM
Stockaholics
17 Oct 14 10:40:59
Platinum Penny Stock Picks Gained 125% last week! New Pick Coming Today! Check It Out: http://t.co/7gQJ2ZCjuq $FTNT $DCTH $SHLM
Pete Stock
17 Oct 14 08:23:52
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
4-traders.com
17 Oct 14 06:30:07
Delcath Systems : PDI Announces Appointment of Graham G. Miao, MBA, Ph.D. as Chief Financial http://t.co/9Pc2ugWrIM $DCTH
Stockaholics
17 Oct 14 00:42:45
Platinum Penny Stock Picks Gained 125% last week! New Pick Coming Today! Check It Out: http://t.co/7gQJ2ZCjuq $FTNT $DCTH $SHLM
Stockaholics
16 Oct 14 20:46:50
ABPI Gained 1,587.50% In 3 days! Big News: http://t.co/7gQJ2ZCjuq $FTNT $DCTH $SHLM
Stockaholics
16 Oct 14 16:05:03
ABPI Gained 1,587.50% In 3 days! Big News: http://t.co/7gQJ2ZCjuq $FTNT $DCTH $SHLM
Penny Stock Secret
16 Oct 14 08:47:12
This Guy Made $4 Million Trading Because He Knew How To Spot Stocks! Click Here http://t.co/SVqoMkrw2z .. $FTNT $DCTH $SHLM
Daily Contracts
16 Oct 14 08:10:02
Real-Time feed of company contracts, original agreements and executive updates from Delcath Systems $DCTH http://t.co/7xYeoBI3dD
Pete Stock
16 Oct 14 08:09:19
@bman_alerts Get your chatziers on small bios $KBIO this week against the grain 1.60---1.88, who's next $OXGN $DCTH $AVEO (1.25 in cash)
Stockaholics
15 Oct 14 23:25:02
ABPI Gained 1,587.50% In 3 days! Big News: http://t.co/7gQJ2ZCjuq $FTNT $DCTH $SHLM
Penny Stock Secret
15 Oct 14 18:05:35
Secret That Has Made GREG, And 22 of his friends and family members MILLIONAIRES! FIND HERE http://t.co/SVqoMkrw2z .. $DCTH $MSBF $VIAS
4-traders.com
15 Oct 14 08:20:17
Delcath Systems : PDI Announces Appointment of Graham G. Miao, MBA, Ph.D. as Chief Financial Officer http://t.co/GtPtxekPPQ $DCTH
Penny Stock Secret
15 Oct 14 01:31:11
Secret That Has Made GREG, And 22 of his friends and family members MILLIONAIRES! FIND HERE http://t.co/SVqoMkrw2z .. $FTNT $DCTH $SHLM
Stockaholics
14 Oct 14 18:21:24
Our Penny Stock Alerts Gained Over 570% Within the past 6 Trading Days! New Picks Coming: http://t.co/OHPRpgNMTU $FTNT $DCTH $SHLM
Penny Stock Secret
14 Oct 14 16:39:57
This guy made $4 million trading because he knew how to spot stocks Great info! Click here http://t.co/qw3PgVxH7j .. $FTNT $DCTH $SHLM
Stockaholics
14 Oct 14 11:18:13
Our Penny Stock Alerts Gained Over 570% Within the past 6 Trading Days! New Picks Coming: http://t.co/OHPRpgNMTU $FTNT $DCTH $SHLM
Stockaholics
13 Oct 14 17:18:20
Our Penny Stock Alerts Gained 400% in the past week! Get the new picks early: http://t.co/StYMxCxzPy $FTNT $DCTH $SHLM
Pete Stock
13 Oct 14 07:06:15
@ACInvestorBlog Feel bad for you 1.95 RT @PeteStock11: $OXGN 2.09 drilling this one is a bit bloaded, looking at $DCTH 1.90s might get there
				
				
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.