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QGEN Hits New High, CSII ORBIT Advances, ANX, GNBT Soars, FDA Panel Snubs PXS


ADVENTRX Pharmaceuticals Inc. (ANX) rose more than 21% on Wednesday following news of commencement of its pivotal phase III clinical study of ANX-188 (purified poloxamer 188) in sickle cell disease. ANX-188 has been provided orphan drug status and fast track designation by the FDA.

Anthera Pharmaceuticals Inc. (ANTH) has completed the previously announced underwritten public offering of 60 million shares of its common stock, offered at a price of $0.66 each. The gross proceeds from the offering were $40.0 million.

ANTH closed Wednesday's trading at $0.65, down 2.81%.

Bioniche Life Sciences Inc. (BNC.TO) (BNC.AX) has scrapped a global veterinary license agreement with Trophogen Inc. effective immediately. The agreement was originally entered into in June, 2010 to provide commercial access for Bioniche to a patented, proprietary superagonist hormone technology platform developed by Trophogen in the veterinary field.

Cardiovascular Systems Inc. (CSII) said Wednesday that it will be submitting module 3, which makes the pre-market approval application for its orbital atherectomy technology in treating severely calcified coronary arteries complete, around March 31, 2013. To date, the company has submitted modules 1 (preclinical) and 2 (manufacturing/quality system) to the FDA and are currently under review. The module 3 will include ORBIT II clinical data and proposed labeling.

CSII closed Wednesday's trading down 5.09% at $13.61.

Generex Biotechnology Corp. (GNBT) soared more than 59% on Wednesday after the company provided an overview of its cancer immunotherapy product AE37 for early stage breast cancer. The company noted that a detailed update on development plans will be provided during the conference call scheduled for Thursday, January 31, 2013.

Immunovaccine Inc. (IMV.V) is scheduled to initiate a phase I/II study for its DPX-0907 cancer vaccine in patients with breast and ovarian cancer during the fourth quarter of 2013. According to the company, a completed phase I trial of the vaccine therapy in breast, ovarian and prostate cancer patients showed DPX-0907 to be safe and well-tolerated while generating specific polyfunctional T cell responses and triggering increases in antigen targeted CD8 T cells.

LipoScience Inc. (LPDX) closed the books on its IPO on Wednesday. The company went public on Jan.25, 2013, offering its shares at a price of $9.00 each. The net proceeds from the offering are expected to be approximately $44.9 million.

NewLink Genetics Corp. (NLNK) has priced its public offering of 4 million shares at a price to $11.40 each. The net proceeds from this offering are expected to be approximately $42.5 million. The offering is expected to close on or about February 4, 2013.

PDL BioPharma Inc.'s (PDLI) vice president of finance and principal accounting officer - Caroline Krumel, resigned her position as effective immediately on January 25th. The company noted that it will begin a search for a new Finance VP.

Pharmaxis Ltd. (ASX: PXS) (PXSLY.PK) announced that the FDA panel has recommended against approving its drug Bronchitol for cystic fibrosis patients in the U.S. The FDA's final decision is set for March 18, 2013. Bronchitol is approved for patients aged 6 years and over in Australia and for patients aged 18 years and over throughout the European Union.

On the ASX, Pharmaxis is down over 45% to A$0.68.

Shares of QIAGEN N.V. (QGEN) touched a new 52-week high on Wednesday after reporting better-than-expected Q4 earnings and revenue. Looking forward to 2013, the company expects to deliver sales and earnings above analysts' estimates. Separately, QIAGEN reported that its KRAS companion diagnostic for colorectal cancer has been adopted by Clarient - a GE healthcare company.

RXi Pharmaceuticals Corp. (RXII) said Wednesday that its second phase I study of its anti-scarring drug, RXI-109, for the management of surgical and hypertrophic scars and keloids, has been fully enrolled. This multi-dose study administers 3 intra-dermal injections over a two week period, in a dose ascending manner, with each subject receiving both active and placebo on a double blind basis.

RBC Life Sciences Inc.'s (RBCL.OB) Neurobright, a dietary supplement formulation that nutritionally supports cognitive function, learning and remembering, is now protected by US Patent 8357422. The patent was awarded Wednesday on the of basis of an 18-month controlled animal study conducted by Dr. Tres Thompson of the School of Behavioral and Brain Sciences at the University of Texas at Dallas.

SciClone Pharmaceuticals Inc. (SCLN) Wednesday said it has renewed its product promotion agreement, till December 31, 2013, with Sanofi for the China market. Four key products namely, anti-epileptic Depakine, hypnotic Stilnox, ACE inhibitor Tritace and Xatral, an alpha-1 adrenergic blocker used to treat benign prostatic hyperplasia or BPH are being promoted by SciClone, under the Sanofi agreement.

SCLN closed Wednesday's trading at $5.03, down 1.37%.

Urologix Inc. (ULGX) has appointed Greg Fluet as its CEO, effective immediately. He has also been elected to the Company's Board of Directors. Fluet joined Urologix as Executive Vice President and COO in July 2008 and served most recently as the company's interim CEO since November 2012.

The company has not regained compliance with the minimum bid price requirement, and it faces delisting from the Nasdaq Capital Market as of the open of business on February 1, 2013, unless it requests a hearing before a NASDAQ Listing Qualifications Panel.

ULGX closed Wednesday's trading at $0.74, down 2.62%.

by RTTNews Staff Writer

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