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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.

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Results for DCTH
Raul Ramirez
29 Jul 15 17:47:43
$DCTH - looking for continuation tomorrow http://t.co/woWMHc6hZ1
DE Asset Management
29 Jul 15 16:34:54
RT @ThePennyPro: All out $DCTH for 12% http://t.co/2UV7FZv8U4
Stock Trade Alerts
29 Jul 15 16:16:35
How Sonar top NASDAQ looked @ today's open: $RADA $AEZS $AMDA $VLTC $NYMX $RGSE $DCTH $VGGL $IMMU $DXM Intro ➡ via http://t.co/LHfNLyngnt
Tommy
29 Jul 15 14:52:40
Current positions. $cbay $cur $rxii. Watching. $dcth $pirs $ptn
PlungeProtectionTeam
29 Jul 15 14:21:09
RT @fm23: $DCTH http://t.co/dYrH0KwfC1
Phil Martin
29 Jul 15 14:11:33
$DCTH http://t.co/dYrH0KwfC1
A Tall Texan
29 Jul 15 13:29:56
$DCTH Looks like base in place, and starting to move higher.
Stock Trade Alerts
29 Jul 15 13:05:27
How Sonar top NASDAQ looked @ today's open: $RADA $AEZS $AMDA $VLTC $NYMX $RGSE $DCTH $VGGL… | SH #TradeAlerts ➡ via http://t.co/LHfNLyERf1
Stock Horizon LLC
29 Jul 15 13:00:54
How Sonar top NASDAQ looked @ today's open: $RADA $AEZS $AMDA $VLTC $NYMX $RGSE $DCTH $VGGL $IMMU $DXM http://t.co/ZsJ8IyObfZ
Michael Cook
29 Jul 15 12:42:26
Our Stock Alerts Gained Over 550% This Month Already! See Our Huge New Pick Coming This Week: http://t.co/abs4Q0eCx9 $FTNT $DCTH $SHLM
Michael James
29 Jul 15 12:38:28
After A MASSIVE 525% Gain On $GEQU, We Have A New Pick Ready! Special Update: http://t.co/wFGuoX67mX $FTNT $DCTH $SHLM
Paul Henry
29 Jul 15 12:29:24
Our Penny Stock Picks Have Gained 3,600% In 10 Months! Get Early Access To Our Next Pick: http://t.co/xXdYdpiHOc $FTNT $DCTH $SHLM
Daily Contracts
29 Jul 15 12:28:05
Real-Time feed of company contracts, original agreements and executive updates from $DCTH http://t.co/q0sRaJqvXu
SuperNova
29 Jul 15 12:02:22
All out $DCTH for 12% http://t.co/PdCffHW7RD
PennyPRO.com
29 Jul 15 12:02:22
All out $DCTH for 12% http://t.co/2UV7FZv8U4
BoardCentral
29 Jul 15 12:02:22
All out $DCTH for 12% http://t.co/DZjeXkZPJo
StockenheimerSchmidt
29 Jul 15 08:32:38
Huge Gains On Stock Picks, Plus A Major Announcment: http://t.co/L7DCrvU4Ev $FTNT $DCTH $SHLM
Michael Cook
29 Jul 15 08:26:54
Our Stock Alerts Gained Over 550% This Month Already! See Our Huge New Pick Coming This Week: http://t.co/abs4Q0eCx9 $FTNT $DCTH $SHLM
Paul Henry
29 Jul 15 08:23:32
Our Penny Stock Picks Have Gained 3,600% In 10 Months! Get Early Access To Our Next Pick: http://t.co/xXdYdpiHOc $FTNT $DCTH $SHLM
Michael James
29 Jul 15 08:21:33
After A MASSIVE 525% Gain On $GEQU, We Have A New Pick Ready! Special Update: http://t.co/wFGuoX67mX $FTNT $DCTH $SHLM
wsnewspublishers
29 Jul 15 07:34:27
Active Stocks Traders Alert: http://t.co/WWai3xguJy $NOK $TXT $DCTH
David Hejmanowski
29 Jul 15 07:26:04
Out of $TPIV this morning @ .4715 for an 18% loss. Bought $DCTH @ .565 this morning.
ProTradersNews
29 Jul 15 07:12:03
$DCTH: Investor's Watch List: CEL-SCI (CVM), Thompson Creek Metals ...: http://t.co/sWGPv4UcKs
FonsieTrader
29 Jul 15 06:39:07
$DCTH On watch
StockenheimerSchmidt
29 Jul 15 04:43:23
Huge Gains On Stock Picks, Plus A Major Announcment: http://t.co/L7DCrvU4Ev $FTNT $DCTH $SHLM
Gotham City Capital
29 Jul 15 01:32:59
$DCTH Great Intraday Setup. MACD Rolling. Oversold. Potential Here Tomorrow. Accum. http://t.co/sRV6QXtJ0K
Paul Henry
28 Jul 15 20:38:37
Our Penny Stock Picks Have Gained 3,600% In 10 Months! Get Early Access To Our Next Pick: http://t.co/xXdYdpAiFK $FTNT $DCTH $SHLM
Michael James
28 Jul 15 20:36:46
After A MASSIVE 525% Gain On $GEQU, We Have A New Pick Ready! Special Update: http://t.co/wFGuoXnIev $FTNT $DCTH $SHLM
FaisamTrader
28 Jul 15 20:32:57
$dcth in at $.55
Michael Cook
28 Jul 15 20:32:51
Our Stock Alerts Gained Over 550% This Month Already! See Our Huge New Pick Coming This Week: http://t.co/abs4Q0wdoH $FTNT $DCTH $SHLM
Michael James
28 Jul 15 16:37:15
After A MASSIVE 525% Gain On $GEQU, We Have A New Pick Ready! Special Update: http://t.co/wFGuoX67mX $FTNT $DCTH $SHLM
Michael Cook
28 Jul 15 16:34:10
Our Stock Alerts Gained Over 550% This Month Already! See Our Huge New Pick Coming This Week: http://t.co/abs4Q0wdoH $FTNT $DCTH $SHLM
Yu Zhu
28 Jul 15 16:13:35
RT @BioBreakout: $DCTH Delcath Systems Director Taglietti Buys 200,000 Shares @$0.53/Share via SEC Form 4
Phil Martin
28 Jul 15 15:42:31
$DCTH http://t.co/U3GYAaWB2A
BioBreakout
28 Jul 15 15:15:48
$DCTH Delcath Systems Director Taglietti Buys 200,000 Shares @$0.53/Share via SEC Form 4
Scoop Dogg
28 Jul 15 14:39:13
stocks w/ spots to watch: $CYTR 2.85 $DCTH .56 $ $IDRA 3.64 $WYY 2.15
StockNews
28 Jul 15 14:10:13
$DCTH - Statement of Changes in Beneficial Ownership (4) http://t.co/efhgtmOBRv
Hot Penny Stocks
28 Jul 15 14:10:12
$DCTH - Statement of Changes in Beneficial Ownership (4) http://t.co/w6349xMj5u
StockTalk
28 Jul 15 14:07:17
$DCTH insider form 4's
Insider Filings
28 Jul 15 14:07:03
$DCTH: STOLL ROGER G PHD bought a net $10,740 in DELCATH SYSTEMS, INC.. http://t.co/RcvO78MkKR
ChuckSometimes
28 Jul 15 13:27:19
RT @DailyStockPlays: ADX Downtrend http://t.co/Ic5iRJvdUc $CTRP $EBIX $EMC $DQ $NSANY $LOGI $MEMP $BIOA $FORM $AVP $TRGT $DCTH $DRIO $BTCS …
PlungeProtectionTeam
28 Jul 15 13:12:55
Another massive insider purchase for $DCTH before Sept catalysts. Thinking this might get bought out
PlungeProtectionTeam
28 Jul 15 13:11:47
RT @insider_filings: $DCTH: Taglietti Marco bought a net $106,783 in DELCATH SYSTEMS, INC.. http://t.co/RcvO78MkKR
StockNews
28 Jul 15 12:55:05
$DCTH - Statement of Changes in Beneficial Ownership (4) http://t.co/x5xfYDgdNn
Hot Penny Stocks
28 Jul 15 12:55:02
$DCTH - Statement of Changes in Beneficial Ownership (4) http://t.co/RLOe1x3euw
ProTradersNews
28 Jul 15 12:55:01
$DCTH: New Insider Transaction on DCTH by Director: http://t.co/fAOPggWyKY
Insider Alerts
28 Jul 15 12:54:08
NEW insider transaction on $DCTH reported a moment ago: http://t.co/YocU7imOy3
Insider Filings
28 Jul 15 12:53:03
$DCTH: Taglietti Marco bought a net $106,783 in DELCATH SYSTEMS, INC.. http://t.co/RcvO78MkKR
Stock Dawgzz
28 Jul 15 10:20:09
Our Platinum Subscribers Saw Their Penny Stock Alerts Gain Over 350% In 2 Weeks! Big Update: http://t.co/OpH8n57Fki $FTNT $DCTH $SHLM
StockenheimerSchmidt
28 Jul 15 10:15:39
Huge Gains On Stock Picks, Plus A Major Announcment: http://t.co/L7DCrvU4Ev $FTNT $DCTH $SHLM
				
				
By  +Follow October 2, 2013 7:28AM
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