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CGEN Plans Busy Year, CytoDyn Gets Going, OREX Gets FDA Date, DRRX On A High


Celgene Corp.'s (CELG) cancer drug Abraxane has been approved in Europe in combination with Gemcitabine for first-line treatment of adult patients with metastatic pancreatic cancer. The drug is also approved for the treatment of breast cancer and non-small cell lung cancer in the European Union and U.S.

In the U.S., Abraxane was approved for pancreatic cancer last September.

Abraxane's sales were $448 million in the first nine months of 2013.

CELG closed Tuesday's trading at $164.61, up 1.22%.

Compugen Ltd. (CGEN) plans to significantly expand its immuno-oncology activities during this year. Accordingly, the company's R&D expenditures for 2014 are anticipated to increase by more than 60%. The company also plans to relocate its U.S. subsidiary to larger facilities in the South San Francisco area in mid-year.

CGEN closed Tuesday's trading 5.46% higher at $10.05.

CytoDyn Inc. (CYDY.OB) has received FDA approval to commence patient screening of a phase 2b study of its investigational antiviral agent PRO 140 for the treatment of patients with Human Immunodeficiency Virus Type 1 (HIV-1).

PRO 140 has a "fast track" status in the U.S.

Commenting on the development, David Feigal, CytoDyn's Chief Medical Officer said, "We believe that commencement of this study brings us one step closer to offering a new treatment paradigm for patients with HIV, who haven't seen any game-changing therapeutic options come to the market in years."

CYDY.OB closed Tuesday's trading at $1.03, down 1.90%.

Galena Biopharma Inc. (GALE) has enrolled the first patient in a phase II trial evaluating its experimental drug GALE-301 in ovarian cancer. The primary objective of the trial is to measure immune response, with secondary outcomes of recurrence, noted the company.

GALE touched a new 52-week high of $5.59 on Tuesday before closing at $5.36.

Impax Laboratories Inc. (IPXL) and DURECT Corp. (DRRX) have signed a $63 million agreement to develop and commercialize DURECT's investigational transdermal patch for the treatment of pain associated with post-herpetic neuralgia.

The agreement calls for Impax to pay DURECT an upfront fee of $2 million, with possible additional payments of up to $61 million upon the achievement of predefined development and commercialization milestones. If ELADUR is commercialized, DURECT would also receive a tiered royalty on product sales.

DRRX set a new 52-week high of $1.92 on Tuesday before closing at $1.88.

IsoRay Inc. (ISR) has been granted FDA clearance to use liquid cesium in its GliaSite radiation therapy system, a balloon catheter device used to treat certain brain cancers.

According to the company, Cesium-131 allows for the precise treatment of many different cancers because of its unrivaled blend of high energy and its 9.7 day half-life (its unequaled speed in giving off therapeutic radiation).

The GliaSite radiation therapy system to treat brain cancer was given FDA clearance in September 2011.

ISR closed Tuesday's trading at $0.55, up 4.51%.

Oculus Innovative Sciences Inc. (OCLS) has made 2 new additions to its U.S. family of Microcyn-based advanced wound care products namely, Microcyn Wound & Skin Spray HydroGel and Microcyn Wound & Skin Care with preservatives.

While Microcyn Skin & Wound Spray HydroGel is available in a three-ounce spray bottle, Microcyn Skin & Wound Care comes in a convenient two-ounce bottle for both clinical and economical in-home patient use.

OCLS closed Tuesday's trading 8.66% higher at $3.89.

Orexigen Therapeutics Inc.'s (OREX) resubmitted New Drug Application for its experimental weight loss drug Contrave has been assigned a decision date of June 10, 2014 by the FDA.

If approved, the company expects commercial launch of Contrave by North American partner Takeda Pharmaceuticals in the second half of 2014.

OREX closed Tuesday's trading at $5.82, up 2.65%.

StemCells Inc. (STEM) is planning to complete the ongoing safety studies in spinal cord injury and age related macular degeneration in the first and second quarters of 2014 respectively. The company will also be initiating controlled phase II efficacy studies in the two indications this year.

STEM closed Tuesday's trading 4.35% higher at $1.44.

by RTTNews Staff Writer

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