ZLCS Effects Reverse Split, STEM Growing Up, Rockwell Rocks, What's Moving PSTI?

(RTTNews) - Delcath Systems Inc. (DCTH) on Wednesday rose more than 112 percent to touch $0.66 before closing at $0.59, following the receipt of FDA's orphan drug designation for chemotherapeutic drug Melphalan in the treatment of patients with hepatocellular carcinoma, the most common form of primary liver cancer.

The company's investigational therapy called Melblez Kit, which is a combination product consisting of the chemotherapy drug Melphalan and a drug delivery device, is being investigated as a treatment for liver cancers.

Delcath is finalizing plans to initiate a staged clinical program to investigate Melblez Kit for first-line treatment of patients with unresectable hepatocellular carcinoma. Subject to acceptance by the FDA, the company will conduct a global, single-arm, open-label, multi-center, phase II clinical trial.

Last month, the FDA issued a complete response letter to Melblez Kit for the treatment of patients with unresectable ocular melanoma metastatic to the liver.

Pluristem Therapeutics Inc. (PSTI) has received approval from Israeli Ministry of Health to initiate a phase II study of its PLacental eXpanded cells in the treatment of Intermittent Claudication, a subset of peripheral artery disease. The protocol will be the same as the one used for the U.S. study.

The company's U.S. phase II Intermittent Claudication study was placed on clinical hold by the FDA in June of this year due to a serious allergic reaction in a case which required hospitalization. However, with the company addressing all the clinical hold issues, the FDA lifted the clinical hold last month.

PSTI closed Wednesday's trading at $3.51, up 1.74%. In after hours, the stock gained another 2.56% to $3.60.

Response Genetics Inc. (RGDX) executed one more health care payor agreement on Wednesday, this time with Fortified Provider Network Inc. This is the seventh health care payor agreement this year and brings its access to over 97 million people nationally, said the company.

RGDX closed Wednesday's trading at $2.35, up 1.29%.

Rockwell Medical Inc. (RMTI) touched a new high of $13 on Wednesday before closing at $11.99, following the company's phase III data of novel iron replacement drug candidate Triferic being accepted as Late-Breaking clinical trial abstract at American Society of Nephrology (ASN) Meeting, which is to be held in November.

Triferic has successfully completed the efficacy trials of its phase III clinical study program, which included two studies dubbed CRUISE-1 and CRUISE-2. The CRUISE-1 trial results were reported in July and CRUISE-2 trial results were reported last month.

StemCells Inc. (STEM) is all set to open U.S. sites for its phase I/II clinical trial for evaluating its proprietary HuCNS-SC human neural stem cells as a treatment for spinal cord injury, now that the FDA has authorized the company's Investigational New Drug application. The trial is currently underway in Switzerland and Canada.

With yesterday's authorization, the FDA has cleared clinical studies of the company's HuCNS-SC cells in all three elements of the CNS, the brain, eye and spinal cord.

The company said its goal is to complete enrollment in the spinal cord injury trial by the first quarter of next year.

StemCells has also offered to sell an aggregate of 11,170,000 units at a public offering price of $1.45 per unit. Each unit consists of one share of common stock, par value $.01 per share, and a warrant to purchase one half share of common stock.

The estimated gross proceeds from the offering is roughly $16.2 million, and is expected to close on or about October 7, 2013, subject to customary closing conditions.

STEM closed Wednesday's trading at $1.47, down 12.50%. In after hours, the stock gained 0.68% to $1.48.

Synergy Pharmaceuticals Inc. (SGYP) is planning to initiate a phase II study of SP-333 for the treatment of opioid-induced constipation this quarter. The phase II study will evaluate a 4-week regimen of SP-333, a once daily oral treatment, in adult patients taking opioid analgesics for chronic, non-cancer pain for at least three months.

SGYP closed Wednesday's trading 1.08% lower at $4.56.

Zalicus Inc. (ZLCS) has sought to effect a 1-for-6 reverse stock split of its common stock, effective as of October 3, 2013, in an effort to regain compliance with the $1.00 per share minimum bid price requirement for continued listing on The Nasdaq Capital Market.

ZLCS plunged more than 17 percent to $0.99 in extended trading on Wednesday.

Biotech stocks can be risky as their fortunes depend on two key events namely clinical trial results and FDA decisions. Nevertheless, the returns can be impressive when the stocks are bought and sold at the right time.

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