Adherex At ASCO, FDA Panel Backs CBST, DRTX, PRAN's IMAGINE Fails, SKBI Shines

(RTTNews) - Adherex Technologies Inc. (AHX.TO)(ADHXF.OB) is scheduled to release final data from a phase III trial of Sodium Thiosulfate, conducted by the US based Children Oncology Group, for prevention of hearing loss in children receiving Cisplatin chemotherapy during the American Society of Clinical Oncology meeting in June 2014. The company will also be presenting safety review data from a European based phase III trial of Sodium Thiosulfate, dubbed SIOPEL 6 Study, at ASCO in June 2014.

Amarin Corp. plc (AMRN) has entered into a co-promotion agreement for its flagship product, Vascepa, in the United States with Kowa Pharmaceuticals America Inc. Vascepa is approved for use in the United States as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.

Kowa is expected to begin its Vascepa promotional efforts in May 2014, and the initial term of the agreement extends through 2018.

AMRN closed Monday's trading at $1.81, down 2.69%. In after-hours, the stock was up 7.73% to $1.95.

Cubist Pharmaceuticals Inc.'s (CBST) investigational antibiotic SIVEXTRO, in intravenous and oral formulations, for the treatment of acute bacterial skin and skin structure infections, has been unanimously recommended for approval by an FDA Advisory Committee.

SIVEXTRO (tedizolid phosphate), which is under FDA priority review, has a decision date set for June 20, 2014.

The European regulatory agency is also reviewing SIVEXTRO, and a decision from the European Commission is expected during the first half of 2015.

CBST closed Monday's trading 4.35% higher at $73.15.

Shares of Durata Therapeutics Inc. (DRTX) climbed over 5 percent to $14.15 in extended trading on Monday after the company's investigational drug, Dalvance, for the treatment of adult patients with acute bacterial skin and skin structure infections won the unanimous backing of FDA panel.

The FDA's final decision on Dalvance is scheduled for May 26, 2014. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

Prana Biotechnology (PRAN) slumped more than 71 percent on Monday to close at $2.80 as its phase II trial of experimental drug PBT2 failed to meet the primary endpoint.

According to the company, in the imaging trial, dubbed IMAGINE, PBT2 did not produce a statistically significant reduction in the levels of beta-amyloid plaques in the brains of prodromal/mild Alzheimer's disease patients.

Skystar Bio-Pharmaceutical Co. (SKBI) rose more than 11 percent on Monday to close at $6.56, following stellar fiscal 2013 financial results.

The company's net income rose to $10.5 million or $1.37 per share on revenue of $42.5 million in fiscal 2013. This compares with net income of $6.2 million or $0.83 per share and revenue of $33.6 million in fiscal 2012.

Venaxis Inc. (APPY) has filed a 510(k) premarket submission for its APPY1 Test, a rapid, multiple biomarker-based index assay for identifying patients that are at low risk for appendicitis.

On March 13, 2014, the company reported that its APPY1 Test performed well, with sensitivity and negative predictive value results that exceeded those from the previous pilot study. The news sent the stock soaring more than 43% to $3.88 that day.

APPY, which has given back most of its gains, closed Monday's trading at $2.63, up 6.05%.