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ETRM Slumps, AVNR Progresses, CRMD Gets Another Extension, LLY Flunks RA Study

ETRM Slumps, AVNR Progresses, CRMD Gets Another Extension, LLY Flunks RA Study

Affymetrix Inc. (AFFX: Quote) and DNA Link Inc., a Korean genomics-based biotechnology company, have signed a partnership for forensic test development for human identification.

Under the partnership, DNA Link will obtain a worldwide license to develop and commercialize a forensic test for comprehensive human identification and other diagnostic tests using Affymetrix' microarray technology and the Korea FDA cleared GeneChip System 3000Dx v.2.

Avanir Pharmaceuticals Inc. (AVNR: Quote) said it has successfully completed the first of a two-stage pharmacokinetic study with AVP-786. Based on interim data, Avanir believes that it has identified a formulation of AVP-786 with a comparable pharmacokinetic, safety and tolerability profile to AVP-923.

A phase II study of AVP-923 in central neuropathic pain in multiple sclerosis is currently underway and data from this study are expected in the fourth calendar quarter of 2013.

BIOLASE Inc. (BIOL: Quote) rose over 9% to close at $3.71 after the company announced it has been issued a new patent covering the use of its laser technologies for treating various conditions of the eye. It was only a day earlier that the company received FDA clearance for its 940nm Diolase 10 diode soft tissue laser for a broad spectrum of medical procedures, sending the stock to a new 52-week high of $3.93.

CorMedix Inc. (CRMD: Quote) has now been granted time until April 15, 2013 to regain compliance with the continued listing standards of the NYSE MKT. The previous extended deadline was January 31, 2013.

The company's primary product candidate in development is Neutrolin (CRMD003) for the prevention of catheter related infections in the dialysis and non-dialysis settings. CorMedix is awaiting the outcome of its application in the European Union for a CE mark for Neutrolin.

Dyax Corp. (DYAX: Quote) on Thursday entered into a strategic partnership with CVie Therapeutics, a subsidiary of Lee's Pharmaceutical Holdings Ltd., for the development and commercialization of KALBITOR in the treatment of hereditary angioedema and other angioedema indications in China, Hong Kong and Macau.

KALBITOR is currently marketed in United States for the treatment of acute attacks of hereditary angioedema in patients 16 years of age and older.

Eli Lilly and Co. (LLY: Quote) has decided to pull the plug on a phase III rheumatoid arthritis program for Tabalumab due to lack of efficacy. This decision is expected to result in a first-quarter charge to research and development expense of about $50 million.

However, the Tabalumab phase III program for systemic lupus erythematosus, dubbed ILLUMINATE, is ongoing and will continue as planned, said the company.

EnteroMedics Inc. (ETRM: Quote) slumped over 49% in extended trading Thursday after the company announced that its phase III trial evaluating VBLOC vagal blocking therapy for the treatment of obesity failed to meet predefined efficacy endpoints.

However, the trial, dubbed ReCharge, did demonstrate a clinically meaningful and statistically significant excess weight loss of 24.4% for VBLOC Therapy-treated patients, with 52.5% of patients achieving at least 20% excess weight loss, noted the company.

Based on the available data, EnteroMedics plans to move forward with a Pre-Market Approval application with the FDA in the second quarter of 2013.

Opexa Therapeutics Inc. (OPXA: Quote) Thursday priced an offering of shares of its common stock and warrants to purchase common stock at $3.00 per unit. The gross proceeds from the offering are expected to be $3.25 million. The offering is expected to close on or about February 11, 2013.

Ventrus Biosciences Inc. (VTUS: Quote) Thursday announced that the overallotment option of its previously announced public offering of $2.50 per share has been fully exercised. The company noted that the exercise of the over-allotment option increases the gross proceeds from $20.0 million to approximately $22.2 million.

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by RTT Staff Writer

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