01.08.2014 06:32:02

ALXA Working Its Way, CERS Awaits FDA Decision, XNCR, SGEN Look Ahead To Results

(RTTNews) - Alexza Pharmaceuticals Inc. (ALXA) is all set to initiate a phase 2a study of AZ-002 for the management of patients with acute repetitive seizures in the second half of 2014.

The company has also identified two product candidates - AZ-008 for the acute treatment of restless legs syndrome (RLS) and AZ-009 for hypomobility, or freezing, during "off periods" in Parkinson's disease patients, which will be taken up for pre-clinical testing.

ALXA closed Thursday's trading at $4.83, down 2.23%.

BioTime Inc.'s (BTX) subsidiary OncoCyte Corp. has expanded the clinical development of its urine-based bladder cancer diagnostic test PanC-Dx by initiating a multi-site clinical trial. The trial is expected to begin enrolling patients within the next week and the goal of the trial is to compare the performance of OncoCyte's proprietary PanC-Dx bladder cancer markers to the performance of cystoscopy.

OncoCyte is initially focusing its efforts on developing PanC-Dx diagnostic products for use in detecting breast, bladder, and lung cancers.

BTX closed Thursday's trading at $2.54, down 3.79%.

Cerus Corp. (CERS) expects FDA decision on the premarket approval application for INTERCEPT Platelets as early as first half of 2015.

The INTERCEPT Blood System, which is based on the company's proprietary Helinx technology for pathogen inactivation, is meant to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The device is designed for three blood components namely, platelets, plasma and red blood cells.

The regulatory review of INTERCEPT Plasma premarket approval application is ongoing, and a decision is now expected as early as Q1-2015.

CERS closed Thursday's trading at $3.52, down 3.03%. In after-hours, the stock gained 6.25% to $3.74.

Seattle Genetics Inc. (SGEN) is scheduled to report phase III trial data of its drug - Adcetris - in the additional indication of treating Hodgkin lymphoma patients at risk of relapse following autologous stem cell transplant by October 2014.

Adcetris, which is approved for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma, is being evaluated broadly in more than 30 ongoing clinical trials.

The company is also expected to report data from phase 2 clinical trials with ADCETRIS by the end of 2014, including trials in diffuse large B-cell lymphoma and Hodgkin lymphoma.

SGEN closed Thursday's trading at $35.20, down 1.92%.

Xencor Inc. (XNCR) has a couple of events lined up for the coming months, which makes the stock, the one to keep an eye on.

The company is scheduled to report top-line data from its phase 2a trial of XmAb5871 in patients with moderate-to-severe rheumatoid arthritis in the second half of 2014. In addition, preliminary data from a phase 1a clinical trial of asthma drug candidate XmAb7195 in healthy subjects and allergic subjects are anticipated by the end of 2014.

XNCR closed Thursday's trading at $9.66, up 0.84%.

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