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ASPX Awaits Results, BZYR Creating Buzz, CGIX Opens Wallet, GNCA Hits A High

Biotechnology 062414

Allergan Inc. (AGN) is asking its shareholders to reject Valeant Pharmaceuticals International Inc.'s (VRX) (VRX.TO) buyout offer as it is grossly inadequate.

The buyout offer allows Allergan stockholders to exchange each of their Allergan shares for $72.00 in cash and 0.83 Valeant common shares, or an amount of cash, or a number of Valeant common shares, in each case subject to proration.

AGN closed Monday's trading at $164.82, down 0.30%.

Auspex Pharmaceuticals Inc. (ASPX) announced that its investigational drug called SD-809 Extended Release (ER) in persons who have chorea associated with Huntington disease has demonstrated clinical activity in a phase III clinical trial.

The company expects top-line data from all enrolled subjects in the phase III study of SD-809, dubbed ARC-HD Switch study, to be reported in the fourth quarter of 2014.

ASPX closed Monday's trading at $21.17, down 6.86%.

Australian biotechnology company Bionomics Limited (BMICY.OB) has licensed its investigational compound BNC375 to Merck & Co Inc. (MRK). This is Bionomics' second agreement with Merck.

The BNC375 research program targets cognitive dysfunction associated with Alzheimer's disease and other central nervous system conditions.

As part of the license agreement, Bionomics will receive upfront payments totaling US$20 million and is eligible to receive up to US$506 million for achievement of certain research and clinical development milestones and undisclosed royalties on any product sales.

The Burzynski Research Institute Inc. (BZYR.OB) has been given the go-ahead for its planned phase III study of Antineoplastons A10/AS2-1 Injections in newly diagnosed diffuse, intrinsic, brainstem glioma.

The FDA had placed a partial clinical hold for enrollment of new pediatric patients under single patient protocols or in any of the active phase II or phase III studies of Antineoplastons in July 2012, following a serious adverse event.

Now that the clinical hold has been lifted, the company is continuing discussions with the FDA in an effort to finalize additional details of the phase 3 study protocol for the potential clinical trial.

BZYR.OB closed Monday's trading at $0.04, up 33.33%.

Cancer Genetics Inc. (CGIX) is all set to acquire privately held Gentris Corp. for approximately $4.75 million, comprised of $3.25 million in cash, $1.5 million in Cancer Genetics stock as well as additional performance-based earnouts of up to $1.5 million.

The transaction is expected to close during the third quarter of 2014.

CGIX closed Monday's trading at $11, down 1.61%.

Genocea Biosciences Inc. (GNCA) touched a new intraday high of $23.99 on Monday before closing at $22.03, following positive top-line results from a phase 1 study of its novel universal pneumococcus vaccine candidate GEN-004.
The company plans to advance GEN-004 into a phase 2a trial in the third quarter of 2014.

A single weekly injection of OPKO Health Inc.'s (OPK) investigational long-acting version of hGH-CTP, Lagova, has been shown to replace seven consecutive daily injections of currently marketed human growth hormone in a phase II study to treat pediatric growth hormone deficiency disorder (GHD).

Based on the encouraging safety and efficacy results, OPKO plans to move aggressively into a single confirmatory pivotal phase III study for pediatric GHD patients.

OPK closed Monday's trading at $9.05, down 1.95%. In after-hours, the stock was up 0.33% to $9.08.

pSivida Corp.'s (PSDV) drug-device combination, Iluvien, has been approved in Italy for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies, marking the seventh national approval in the EU for the product.

Iluvien is authorized in Austria, the United Kingdom, Portugal, France, Germany and Spain and is commercially available in the U.K. and Germany.

Iluvien is not approved by FDA yet, and has a decision date set for September 26, 2014.

PSDV closed Monday's trading at $4, up 0.25%.

XenoPort Inc. (XNPT) has initiated a phase II clinical trial of its drug candidate XP23829 in the treatment of patients with moderate-to-severe chronic plaque-type psoriasis.

The study is designed to enroll approximately 200 subjects in this trial, which is being conducted in the United States, and top line results are expected in the third quarter of 2015.

XNPT closed Monday's trading 0.64% higher at $4.71.

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