Delcath Systems Inc (DCTH)

[byomond]

An Undervalued Stock With Significant Upcoming Catalysts: Delcath Systems

http://www.smallcapnetwork.com/An-Undervalued-Stock-With-Significant-Upcoming-Catalysts-Delcath-Systems/s/via/22880/article/view/p/mid/1/id/1/

There is a common saying in the investing community; oneman’s junk is another man’s treasure. By now it may sound like a cliché, but the market is dominated by beaten-down shares. It takes a rather simplistic view to understand the concept. But it is all about perception, and beaten-down stocks are not necessarily junk if you do your research. And positive perception on a solid stock will always remain intact with due diligence on the company's history and outlook.

Many times, an over reaction of the market causes selling pressure on a stock, which may lead some stockholders to even doubt their own position. It creates a domino effect, and soon you have everyone following the leader. To invest, it takes discipline, it takes calculation, and most importantly, it takes keeping your eyes on the price. Remaining focused is the name of the game. If you have been investing for some time now, you may be familiar with jumping off the wagon to later find out the stock made a big run-up, only to miss it by a few days. Common mistake made by most, but human nature tends to favor that reaction, thus taking away any reason, and vision as we become impatient. A company discussed here has upcoming major events, and can be very enticing if you keep your eyes on the ball. It has a promising pipeline, and for the calculated investors, may offer a good entry point for significant price appreciation as an undervalued stock.

Delcath Systems is a specialty pharmaceutical and medical device company focused on oncology. They own the rights to a drug/device combination product, the Delcath Hepatic Delivery System, which is designed to administer high dose chemotherapy and other therapeutic agents to a diseased organ or regions of the body. The device is designed to control the systemic exposure of those agents when being administered to target region of the body. This process is called chemosaturation therapy.

In a Phase 3 clinical trial, the company reported that patients with metastatic melanoma in the liver had successfully achieved the study's primary endpoint of extended hepatic progression-free survival. The Company's initial focus is on the treatment of primary and metastatic liver cancers. But the company shows tremendous progress in this area of innovation, and ultimately plans to expand the range of cancers suitable for treatment with chemosaturation therapy.

The company has made great strides in the regulatory process. Below is a timeline for significant events in the course of their regulatory path as well as upcoming ones (bold):


• April 13, 2011 – Delcath receives notice of European regulatory approval for hepatic CHEMOSAT (Chemosaturation System) Delivery System.

• August 15, 2012 – Delcath submits new drug application for proprietary Chemosaturation Delivery System to the U.S. FDA.

• November 05, 2012 – Delcath receives regulatory approval in Australia for the generation two hepatic CHEMOSAT (Chemosaturation) Delivery System for mephalan hydrochloride.

• February 27, 2013 – Delcath announces ODAC meeting review date for its proprietary drug/device combination product Chemosaturation Delivery System with melphalan hydrochloride.

• May 2, 2013 - ODAC meeting to review the NDA with a proposed indication for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver.

• September 13, 2013 – FDA’s Prescription Drug User Fee Act (PDUFA) goal date for its review of the Company’s New Drug Application (NDA).

The company’s finances are also strong. Yesterday, in a press release, the company reported approximate $42 million cash position at March 31, 2013, which is expected to provide the company with sufficient resources for at least the next 12 months as the Company pursues three key objectives: U.S. FDA approval for MelblezTM Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), European commercialization of CHEMOSAT Hepatic Delivery System for melphalan hydrochloride, and ongoing clinical development focused on label expansion. The company is also conserving cash and it is playing its cards strategically as it meets this year’s objectives and continues to be very transparent with its stockholders, a quality that’s most apparent with this company.

The company closed yesterday at $1.65, a price depreciation of 95% from the stock’s 52 week highs ($3.22). With the upcoming event, ODAC meeting, there is significant price appreciation potential, especially with a drug with an unmet need. These kinds of catalyst events, such as going on front of an Advisory Panel, tend to make explosive runs as they approach the key date. A good example is Endo Health Solutions (ENDP) which has a drug going on front of the Advisory Panel on April 18, next week. ENDP’s shares made a run on February 25, and started another run on April 2. Another example is Theravance (THRX), which also has a drug going on front of an Advisory Panel next week, made an explosive run in two days, starting March 1. If we take a look at DCTH, we begin to notice that it is an extremely undervalued stock now. It closed yesterday at $1.65 on a big board stock exchange.

As with any investing stock, it carries its risk, but with still 18 trading days away, there is great potential for price appreciation with DCTH, and even doubling up from here. This scenario creates a good calculated move for an entry point because it appears DCTH is currently oversold, and has one very near catalyst event, which can trigger a run-up any time prior a key date.

http://www.smallcapnetwork.com/An-Undervalued-Stock-With-Significant-Upcoming-Catalysts-Delcath-Systems/s/via/22880/article/view/p/mid/1/id/1/