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ONCY Completes Study Enrollment, LMNX Files For NxTAG Approval, ADXS On Watch

Pharma1 082615

Advaxis Inc. (ADXS) has entered into a licensing agreement with Knight Therapeutics Inc. (GUD.TO) to commercialize in Canada Advaxis's product portfolio including its three lead drug candidates - axalimogene filolisbac for human papilloma virus (HPV)-associated cancers, ADXS-PSA for prostate cancer and ADXS-HER2 for HER2 expressing solid tumors.

Advaxis is eligible to receive up to $30 million in milestone payments from Knight under the terms of the licensing agreement.

In connection with the licensing agreement, Knight is purchasing directly from Advaxis 359,454 shares at $13.91 per share, which represents a 7% premium to the price of Advaxis's common stock at market close on August 25, 2015. In addition, Sectoral Asset Management, a leading Canadian-based global healthcare investment advisor, is purchasing 1,437,815 shares at $13.91 per share directly from Advaxis on behalf of its clients. The combined gross proceeds to Advaxis from these direct investments is $25 million.

ADXS closed Wednesday's trading at $13.65, up 5%. In after hours, the stock was up 0.37% at $13.70.

The Centers for Medicare and Medicaid Services Advisory Panel on Clinical Diagnostic Laboratory Tests has voted unanimously to maintain Medicare's current reimbursement rate of $492.72 for Exact Sciences Corp.'s (EXAS) Cologuard. A final determination is expected to be released in the November timeframe and will be effective January 1, 2016.

Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer.

EXAS closed Wednesday's trading 6.80% higher at $21.06. In after hours, the stock was up 4.42% at $21.99.

Luminex Corp. (LMNX) has submitted a 510(k) application to the FDA for the company's NxTAG Respiratory Pathogen Panel.

This panel is the only respiratory assay that will easily enable laboratories to simultaneously detect 21 respiratory pathogens in a single closed tube system in a format that scales to changes in throughput requirements and responds to seasonal changes in demand, according to the company.

Luminex expects to receive FDA clearance and CE-IVD marking before the end of the year.

LMNX closed Wednesday's trading at $18.41, up 1.94%.

Oncolytics Biotech Inc. (ONC.TO) (ONCY) has completed enrollment in its phase II study of REOLYSIN in patients with previously treated advanced or metastatic non-small cell lung cancer.

The trial has enrolled a total of 166 patients were enrolled, and its primary objective is to evaluate the effect of REOLYSIN in combination with standard salvage chemotherapy on the progression free survival of patients with advanced or metastatic non-small cell lung cancer.

ONCY closed Wednesday's trading at $0.52, up 4.19%.

VBI Vaccines (VBIV) anticipates beginning a human phase I clinical trial of its cytomegalovirus vaccine candidate in the first quarter of 2016.

The CMV vaccine candidate is being manufactured at a 50L production scale with high yields and purity, the company noted.

VBIV closed Wednesday's trading 5.91% higher at $2.51.

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