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Daily Dose: VNDA Soars, GENT Responds, NAVB Files MAA, NBIX Starts Kinect 2


Shares of Vanda Pharmaceuticals Inc. (VNDA) rose as much as 37 percent in intraday trading on Tuesday before closing nearly 19 percent higher at $3.83, following positive phase III results of its sleep drug candidate - Tasimelteon.

In the first phase III study, dubbed SET, where Tasimelteon was evaluated as a treatment of Non-24-Hour Disorder, the compound succeeded in the primary endpoint of entrainment of the melatonin (aMT6s) rhythm as compared to placebo.

Topline data from the second phase III study of Tasimelteon, dubbed RESET, is expected in Q1, 2013. If all goes well as planned, Vanda plans to submit a New Drug Application to the FDA in mid-2013.

Gentium S.p.A (GENT) on Tuesday submitted responses to the second List of Outstanding Issues to the European Medicines Agency's Committee for Medicinal Products for Human Use related to Defibrotid Marketing Authorization Application.

Gentium submitted the Marketing Authorization Application seeking approval of Defibrotide for the treatment of severe Veno Occlusive Disease last May. An opinion from the CHMP regarding the approval of Defibrotide is expected during Q1, 2013.

The company has been working closely with the FDA in connection with the resubmission of the Defibrotide NDA, which is expected to be filed as early as the first half of 2013.

Theravance Inc. (THRX) announced that a New Drug Application seeking approval of Umeclidinium bromide/Vilanterol, or UMEC/VI, for treating patients with chronic obstructive pulmonary disease has been submitted to the FDA.

UMEC/VI is a development program under Theravance's respiratory franchise that is partnered with GlaxoSmithKline. Regulatory filings for UMEC/VI are planned in the European Union imminently and in other countries during the course of 2013.

Merck & Co. Inc. (MRK) and GE Healthcare have entered into an agreement for the use of an imaging agent to support the development of Merck's lead investigational candidate for Alzheimer's disease - MK-8931.

Under the agreement, GE Healthcare will supply Flutemetamol, an investigational positron emission tomography imaging agent, to help select patients for clinical trials and evaluate this investigational agent as a companion diagnostic tool.

Orexigen Therapeutics Inc. (OREX) announced that screening of new patients for the cardiovascular outcomes trial evaluating Contrave, dubbed the Light Study, has been completed.

Orexigen's lead obesity drug candidate - Contrave, was issued a complete response letter last January on cardiovascular safety concerns, and was asked to conduct a cardiovascular outcomes trial for the drug before it could be approved.

The company anticipates resubmitting the Contrave New Drug Application and conducting the interim analysis in 2013, with potential approval as early as fourth quarter 2013.

Galena Biopharma (GALE) announced that it has priced an underwritten public offering of 15.15 million units at a price to the public of $1.60 per share, or total gross proceeds of $24.25 million.

The offering is expected to close on December 21, 2012, subject to customary closing conditions.

GeoVax Labs Inc. (GOVX.OB) announced Tuesday that its phase I trial of DNA/MVA vaccine for the prevention of HIV infection, designed to enroll 48 patients is now fully enrolled.

The phase I trial is being conducted by the NIH-sponsored HIV Vaccine Trials Network. The trial is expected to be completed in mid-2013.

Navidea Biopharmaceuticals Inc. (NAVB) has submitted Marketing Authorization Application for Lymphoseek to European Medicines Agency, seeking approval for use in intraoperative lymphatic mapping.

Intraoperative lymphatic mapping, or ILM for short, is a surgical oncology procedure in which lymph nodes draining the area around a tumor are identified and biopsied to determine if cancer has spread to the lymph nodes.

In October of this year, the company resubmitted its Lymphoseek NDA to the FDA in response to the Complete Response Letter received in September 2012. The filing has been considered a class 2 response and a decision date is set for April 30, 2013.

Neurocrine Biosciences Inc. (NBIX) has initiated a second phase IIb trial of NBI-98854, dubbed Kinect 2 Study, for treatment of Tardive Dyskinesia.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities: lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is currently no known treatment.

The company expects topline data from the Kinect 2 Study in mid-2013.

The first phase IIb trial of NBI-98854, dubbed Kinect Study, for treatment of Tardive Dyskinesia was initiated in October of this year - with topline data expected in Q2, 2013.

by RTTNews Staff Writer

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