NBIX Craters, DHRM Gets Busy, TGTX, BLRX Compounds Get Orphan Drug Status

(RTTNews) - Shares of Neurocrine Biosciences Inc. (NBIX) plunged 29 percent to $11.85 in extended trading on Monday after the company announced that a phase IIb trial of its investigational drug NBI-98854 of 50mg dosage for treatment of tardive dyskinesia failed to meet the primary endpoint of improvement in tardive dyskinesia symptoms.

The trial, dubbed Kinect Study, evaluated 50mg and 100mg of once-daily NBI-98854 over a six-week placebo-controlled dosing period in moderate to severe tardive dyskinesia patients with underlying schizophrenia or schizoaffective disorder. The primary endpoint of the study is AIMS (Abnormal Involuntary Movement Scale) total dyskinesia score.

The company noted that although the 50mg dose of NBI-98854 did not reach statistical significance for the primary endpoint at Week 6, the 100mg dose showed a statistically significant and clinically meaningful reduction in tardive dyskinesia symptoms at Week 2.

Neurocrine intends to conduct an additional phase II study utilizing 100mg and higher doses of NBI-98854.

Dehaier Medical Systems Ltd. (DHRM) has won a bid for a large-scale medical equipment procurement project valued at approximately $600,000 from Beijing Kanglian Medicine Co.

The project is part of the China Development Bank's Rural Medical and Healthcare Infrastructure Project in Guizhou and Hebei provinces.

DHRM gained 3.59% on Monday to close at $2.02.

TG Therapeutics Inc.'s (TGTX) investigational glycoengineered anti-CD20 monoclonal antibody Ublituximab (TG-1101) has received Orphan Drug designations from FDA for two rare subtypes of non-Hodgkin's lymphoma namely, Nodal Marginal Zone Lymphoma and Extranodal Marginal Zone Lymphoma.

Ublituximab is under phase I/II study in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The drug candidate in combination with Revlimid is also under phase I/II study in patients with B-cell lymphoid malignancies.

Both the studies are currently recruiting participants.

TGTX closed Monday's trading 1.12% higher at $6.32.

Zalicus Inc. (ZLCS) has initiated a phase 1b clinical study with Z944, its novel oral T-type calcium channel blocker, in an experimental clinical model of neuropathic pain using Laser-Evoked Potentials. Results from the study are expected in the fourth quarter 2013.

ZLCS closed Monday's trading at $0.81, down 3.57%.

BioLineRx Ltd.'s (BLRX) drug candidate BL-8040, which is under phase II study in patients with relapsed/refractory acute myeloid leukemia has been granted an Orphan Drug Designation by FDA. The company expects partial results from the study towards the end of 2013.

BLRX surged more than 10 percent to close Monday's trading at $2.30. In after hours, the stock gained another 2.61% to $2.36.

Oncolytics Biotech Inc.'s (ONC.TO) (ONCY) investigational drug REOLYSIN in combination with carboplatin and paclitaxel has demonstrated 92% overall tumor shrinkage in patients with squamous cell carcinoma of the lung in a phase II study.

The company expects to report final progression-free survival and safety data for the study later in 2013.

ONCY rose 12.83% to close Monday's trading at $2.99. In after-hours, the stock gained another 2.01% to $3.05.