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PSTI Rises, NNVC Touts, LMNX Gets Approval, OPXA Gains Compliance, PMBS Relieved


Pluristem Therapeutics Inc. (PSTI) has received approval from German regulatory body to initiate a phase II study using PLX-PAD cells in patients suffering from Intermittent Claudication. The international study extends FDA phase II trial that began in the U.S. The company plans to expand into clinical sites in Israel, following regulatory approval. PSTI closed Tuesday's trading 6.79% higher at $3.46.

Alnylam Pharmaceuticals Inc. (ALNY) on Tuesday priced a public offering of 8 million shares of its common stock at $20.13 per share. The offering is expected to close on or about January 22, 2013, subject to the satisfaction of customary closing conditions. The stock closed Tuesday's trading at $20.13, down 2.04%.

Onyx Pharmaceuticals Inc. (ONXX) has announced an underwritten public offering of 4.4 million shares of its common stock. The offering is expected to close on or about January 22, 2013, subject to customary closing conditions.

Nephros Inc. (NEPH.OB) on Tuesday received the third and final installment of €600,000 from Bellco S.r.l. under a license agreement that has been in effect since July 1, 2011.

Under the terms of the license agreement, Nephros provided an exclusive license to Bellco S.r.l. for its mid-dilution technology for Canada, Italy, France, Spain, and Belgium for the period July 1, 2011 to December 31, 2016, in exchange for €1.85 million in three installments.

In addition, for the period January 1, 2015 until December 31, 2016, Bellco will pay to Nephros a royalty of €4.50 per unit up to 103,000 units and €4.00 per unit above 103,000 units sold per year. The stock closed Tuesday's trading 2.36% higher at $1.30.

Pacira Pharmaceuticals Inc. (PCRX) fell over 7% to $17.65 after the market-close on Tuesday following the company's proposed offering of $100 million of convertible senior notes due 2019.

The company intends to use about $30.0 million of the net proceeds of the offering to repay all amounts outstanding under, and to terminate, its senior secured credit facility, and the remainder of the net proceeds from the offering to fund the continued commercialization of its lead product EXPAREL, approved for postsurgical pain management, and the development of additional indications for EXPAREL and for general corporate purposes.

Eli Lilly and Co.'s (LLY) radiopharmaceutical Amyvid (Florbetapir F 18 Injection) on Tuesday received approval in the European Union for use in patients with cognitive impairment being evaluated for Alzheimer's disease and other causes of cognitive impairment.

Amyvid is expected to be available in select areas within the European Union beginning in Q2 2013.

GeoVax Labs (GOVX) on Tuesday said it expects meaningful data from an ongoing phase 1/2 "treatment interruption" clinical trial, investigating the use of its vaccines for treatment of individuals already infected with HIV later this year. The second phase I therapeutic trial that will investigate the use of its vaccines in combination with standard-of-care drug therapy in HIV-positive young adults is scheduled to begin in mid-2013.

Galectin Therapeutics Inc. (GALT) on Tuesday announced the appointment of industry veteran Rex Horton as Executive Director of Regulatory Affairs and Quality Assurance. The stock closed Tuesday's trading at $2.45, up 14.49.

Luminex Corp. (LMNX) on Tuesday received FDA clearance for its xTAG Gastrointestinal Pathogen Panel, a multiplexed nucleic acid test for the detection of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens.

According to the company, xTAG Gastrointestinal Pathogen Panel simultaneously tests for greater than 90% of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single molecular test.

LMNX closed Tuesday's trading 1.89% higher at $17.81. In after-hours, the stock further climbed 1.01% to $17.99.

Opexa Therapeutics Inc. (OPXA) on Tuesday announced it has regained full compliance with NASDAQ minimum bid price listing requirement. The stock closed Tuesday's trading at $1.26, up 0.63%.

Sunshine Biopharma Inc. (SBFM) announced Tuesday that its parent company Advanomics Corp. has filed a new patent application for Adva-27a.

Adva-27a is Sunshine Biopharma's lead anticancer compound, a small molecule that has recently been shown to be effective at killing multidrug resistant breast cancer cells as well as other aggressive cancer cells in vitro. The compound is currently in the IND-Enabling stage of development.

Navidea Biopharmaceuticals Inc. (NAVB) on Tuesday announced it has completed an additional fundamental clinical trial for radiopharmaceutical agent, AZD4694 (NAV4694), in Alzheimer's disease. Results from this study are expected to be reported at the 2013 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging.

The study was designed and conducted by Navidea's partner, AstraZeneca plc (AZN), to assess the effects of various mass amounts of AZD4694 (NAV4694) on safety and the efficacy of Positron Emission Tomography scanning in subjects with AD and in healthy volunteers (HVs). A phase III study of NAV4694 is expected to be initiated in 2013.

PuraMed BioScience Inc.'s (PMBS.OB) over-the-counter, homeopathic migraine pain reliever formulation, LipiGesic M, has received a Notice of Allowance for its patent application from the United States Patent and Trademark Office. LipiGesic M is currently available over-the-counter at Walgreens and CVS/pharmacy stores.

A clinical study evaluating LipiGesic M for treatment of migraine in children and adolescents is underway, and results are expected this year.

NanoViricides Inc. (NNVC.OB) on Tuesday said that its oral anti-influenza drug candidate has shown significantly superior efficacy to Tamiflu in animal studies. The company revealed it is rapidly advancing towards its goal of filing an IND with the FDA for Influenza based on the guidance received in its previous pre-IND meeting with the regulatory agency.

Shares of Tranzyme Inc. (TZYM) have been trading below $1 since Nov.15, 2012, ever since its first phase IIb trial of TZP-102 in diabetic patients with gastroparesis failed to meet its primary efficacy endpoint and a second phase IIb trial of TZP-102 was halted.

On Tuesday, the company promoted David Moore who has been serving as Vice President, Commercial Operations since August 2011 to the post of Chief Business Officer.

Synergy Pharmaceuticals Inc. (SGYP) is all set to merge with Callisto Pharmaceuticals Inc. (CLSP.OB), pursuant to a previously announced Agreement and Plan of Merger. The merger is expected to close as soon as practicable.

by RTTNews Staff Writer

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