Friday, 23 August 2013

Upcoming FDA PDUFA: Delcath Systems - Melblez (melphalan) - Unresectable ocular melanoma metastatic to the liver

Delcath Systems is awaiting an FDA drug approval decision on Sept 13, 2013 for an application of a new drug as part of a two-component drug-device system - the Delcath Hepatic Delivery System

Date of FDA Decision (PDUFA): September 13, 2013
Company name: Delcath Systems
Stock tickerDCTH
LocationQueensbury, NY
Type of application: first NDA
Name of drugMelblez for Delcath Hepatic Delivery System
Indication: Unresectable ocular melanoma metastatic to the liver

24th July 2013:
Market Cap
$34.77 Mln
52-week range
0.35 – 2.38
Avg. volume
Q1 2013:

Net Loss
$0.15 per share
$42.8 mln

Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on oncology. The company’s lead product is a drug/device combination Delcath Hepatic Delivery System, designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic (rest of body) exposure of those agents. The company's initial focus is on the treatment of primary and metastatic liver cancers. 

Melblez, the compound awaiting an FDA decision on September 13, is the drug component of the two-component Hepatic Delivery System. On May 2nd, 2013, Delcath’s stock plunged when the FDA Oncologic Drugs Advisory Committee (ODAC) voted 16 to 0 with no abstentions that benefits of treatment with Delcath's Melblez Kit for the treatment of patients with unresectable ocular melanoma metastatic to the liver do not outweigh the risks associated with the procedure. 

The FDA has yet to deliver a decision on September 13, 2013. 

Click here for a free report on the upcoming PDUFA stock catalysts in 2013.

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