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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
ProVesting
27 Mar 15 13:50:03
$DCTH: New SEC Filing for DCTH: Form 8-K (No. 0001193125-15-109560): http://t.co/gJdharExeR
4-traders.com
27 Mar 15 13:49:13
#DELCATH SYSTEMS : Change in Directors or Principal Officers, Financial Statem... http://t.co/QOoDfosBGo $DCTH
StockNews
27 Mar 15 13:49:10
$DCTH - Current Report Filing (8-k) http://t.co/u7YfYs4TsR
SEC Filings Reporter
27 Mar 15 13:49:08
NEW SEC Filing for $DCTH filed a moment ago: http://t.co/B5HaZpNW3e http://t.co/aV97m2q3mW
Stocks News&Markets
27 Mar 15 13:49:06
$DCTH - Current Report Filing (8-k) http://t.co/oY3gsJZ3tx
mHealth Reporter
27 Mar 15 13:48:52
RT @BV_Healthcare: $DCTH Delcath Systems, Inc files Form 8-K (Events or Changes Between Quarterly Reports) SEC Filing.. http://t.co/x1hNSrK…
BV Healthcare
27 Mar 15 13:47:05
$DCTH Delcath Systems, Inc files Form 8-K (Events or Changes Between Quarterly Reports) SEC Filing.. http://t.co/x1hNSrKJGw
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27 Mar 15 12:24:36
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27 Mar 15 10:51:27
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27 Mar 15 08:47:49
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FonsieTrader
27 Mar 15 08:46:11
RT @ACInvestorBlog: $DCTH breaking out of a base formation. Could move up sharply soon. Just needs volume.
Antonio Costa
27 Mar 15 08:45:53
$DCTH breaking out of a base formation. Could move up sharply soon. Just needs volume.
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$DCTH on the move
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Briefing.com
27 Mar 15 07:38:32
$DCTH: Delcath announces the reporting of data from a single -center experience utilizing its Melphalan... http://t.co/qSFXFDtsb5
FonsieTrader
27 Mar 15 07:01:15
$DCTH On high alert
LHA
27 Mar 15 06:09:27
Data Highlighting $DCTH Mephalan/HDS Presetented at #SSO2015 #irchat #oncology >>> Read more at: http://t.co/wCVhszC93b
Breaking News
27 Mar 15 05:40:04
$DCTH: Data Highlighting Delcath's Melphalan/HDS Presented At The ...: http://t.co/eOsDL1Oa9G
BreakingStocksNews
27 Mar 15 05:35:02
$DCTH: Single-center, retrospective study evaluates Hepatic Progression ...: http://t.co/AK7w2x1a6K
NASDAQ
27 Mar 15 05:32:09
$DCTH - Data Highlighting Delcath's Melphalan/HDS Presented At The Society Of Surgical Oncology Annual Meeting http://t.co/UM2SCc49Po
Stocks News&Markets
27 Mar 15 05:32:08
$DCTH - Data Highlighting Delcath's Melphalan/HDS Presented At The Society Of Surgical Oncology Annual Meeting http://t.co/bOf9RB53gV
StockNews
27 Mar 15 05:32:07
$DCTH - Data Highlighting Delcath's Melphalan/HDS Presented At The Society Of Surgical Oncology Annual Meeting http://t.co/KUQx6t4y74
Stock Dawgzz
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By  +Follow October 2, 2013 7:28AM
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