ACUR To Meet With FDA, CYTX Does A Deal, NNVC Renews Contract, RGLS On Watch

(RTTNews) - Acura Pharmaceuticals Inc. (ACUR) whose phase III trial, dubbed Study AP-ADF-301, suffered a clinical trial setback in August of this year, intends to meet with the FDA on December 5, 2013 to discuss the study results.

In Study AP-ADF-301, hydrocodone bitartrate and acetaminophen formulated with abuse deterrent AVERSION technology was compared to an equivalent dose of a generic hydrocodone/acetaminophen tablet currently on the market. The trial failed to reach statistical significance in the primary endpoint relating to maximum drug liking.

ACUR closed Monday's trading at $1.73, up 0.58%. In after-hours, the stock was up 9.83% to $1.90.

Becton, Dickinson & Co.'s (BDX) wholly-owned subsidiary BD Rx Inc. has received FDA approval for Morphine Sulfate Injection, USP for the management of pain not responsive to non-narcotic analgesics. BD Rx will begin production of morphine immediately and projects initial product availability in early calendar year 2014.

BDX closed Monday's trading at $106.56, up 1.32%. In after-hours, the stock gained another 0.23% to $106.80.

BioLineRx (BLRX) has received regulatory approval from the Finnish National Supervisory Authority for Welfare and Health to commence a phase 1/2 safety trial for BL-7010, for the treatment of celiac disease. The study is expected to begin by the end of this year.

BLRX closed Monday's trading at $2.65, up 1.92%.

Cellular Dynamics International (ICEL), which is a developer of induced pluripotent stem cell technologies, is all set to enter into a definitive agreement with the California Institute of Regenerative Medicine, or CIRM, to create a human induced pluripotent stem cell (iPSC) biobank from 3,000 individuals. The CIRM will provide a grant of $16 million for the 3-year project.

ICEL closed Monday's trading at $14.99, up 0.40%.

Cytori Therapeutics (CYTX) rose over 45 percent to $3.05 in extended trading on Monday after the company announced a partnership with Beijing-based Lorem Vascular to commercialize Cytori Cell Therapy for the cardiovascular, renal and diabetes markets in China, Hong Kong, Malaysia, Singapore and Australia.

Under the agreement, Lorem Vascular committed to pay up to $531 million in license fees, opening product purchase commitments and Cytori equity purchases. Cytori Cell Therapy is derived from the Company's Celution System, which enables access to a patient's own adipose-derived regenerative cells (ADRCs) at the point-of-care.

Keryx Biopharmaceuticals Inc. (KERX) is all set to announce top-line results from its phase II study of Zerenex in non-dialysis dependent chronic kidney disease patients with elevated serum phosphorus and iron deficiency anemia on November 5, 2013. The company will host a conference call at 8:30am ET after announcing the results.

KERX closed Monday's trading 4.32% higher at $11.10. In extended trading, the stock was up 7.21% at $11.90.

NanoViricides Inc.'s (NNVC) DengueCide evaluation contract has been renewed with the Professor Eva Harris Laboratory at the University of California, Berkeley effective Nov.4, 2013.

DengueCide was recently awarded orphan drug status by the FDA, and the company is pursuing similar status with the European Medicines Agency.

NNVC closed Monday's trading at $5.10, down 3.77%.

NeoStem Inc.'s (NBS) subsidiary, Progenitor Cell Therapy LLC, or PCT, has entered into a cell therapy manufacturing collaboration with ATMI Inc. (ATMI). The agreement allows PCT and PCT's affiliates to offer to their respective clients access to the Integrity Xpansion technology platform from ATMI.

NBS closed Monday's trading at $6.37, up 2.58%.

Regulus Therapeutics Inc. (RGLS) will be commencing clinical trials of its HCV drug candidate RG-101 in man in early 2014. According to the company, RG-101 utilizes a unique mechanism of action by targeting microRNA-122, a liver-specific host factor for stability, replication and translation of HCV.

RGLS closed Monday's trading at $7, up 4.01%.

Repros Therapeutics Inc. (RPRX) said that the full clinical hold for oral Proellex for the treatment of uterine fibroids, imposed by the FDA in August 2009, will be lifted as soon as the company submits a request for lifting of the full clinical and a new protocol for the study.

The same design will be used for the vaginal phase 2b study of Proellex and expects to start the two studies in early 2014.

RPRX closed Monday's trading at $17.54, down 2.61%. In after-hours, the stock lost another 0.80% to $17.40.

Zalicus Inc. (ZLCS) is scheduled to report top-line data from two phase II clinical trials of Z160, including lumbosacral radiculopathy and postherpetic neuralgia, in the fourth quarter of 2013. Z160 has orphan drug status from the FDA for the management of postherpetic neuralgia.

The company is also planning to initiate a phase 2 clinical study in an appropriate pain indication with a modified release formulation of Z944 next year.

ZLCS closed Monday's trading at $4.18, down 7.73%. In extended trading, the stock was down 2.87% to $4.06.