Keep An Eye On Nicox, OPK Gets FDA Nod, PBMD Abuzz, RDHL On The Move

(RTTNews) - ContraVir Pharmaceuticals Inc. (CTRV) has dosed the first patients with chronic hepatitis B in its head-to-head phase IIa study comparing its CMX157 against Gilead Sciences Inc.'s (GILD) Viread.

The study is designed to enroll a total of 60 treatment-naïve patients with chronic HBV infection. It is expected to conclude in the fourth quarter of 2016.

CTRV closed Tuesday's trading at $0.97, up 3.19%.

Nicox S.A's (NICXF.OB) New Drug Application for AC-170 for the treatment of ocular itching associated with allergic conjunctivitis has been accepted for priority review by the FDA. The regulatory agency's final decision is set for October 18, 2016.

Another NDA of the company under review is that of VESNEO (Latanoprostene bunod) for patients with open angle glaucoma or ocular hypertension. The FDA'S decision date on VESNEO is slated for July 21, 2016.

NICXF.OB closed Tuesday's trading at $12.85, up 4.90%.

Shares of OPKO Health Inc. (OPK) rose over 5% on Tuesday, following FDA approval of RAYALDEE for the treatment of secondary hyperparathyroidism associated with Vitamin D insufficiency in Stage 3-4 Chronic Kidney Disease.

RAYALDEE is expected to be launched in the U.S. in the second half of 2016.

OPK closed Tuesday's trading at $9.70, up 5.55%.

Perrigo Co. plc (PRGO) has received final FDA clearance for three milk-based, store brand non-GMO infant formulas.

The three FDA-cleared products include Infant Non-GMO to the nutrition of Enfamil Infant Non-GMO, Advantage Non-GMO to the nutrition of Similac Advance Non-GMO and Sensitivity Non-GMO to the nutrition of Similac Sensitive Non-GMO.

Shipments to retail customers have already commenced, noted the company.

PRGO closed Tuesday's trading at $96.45, down 0.31%.

Shares of Prima BioMed Ltd. (PBMD) were up over 10% in extended trading on Tuesday, following encouraging initial safety data from the first cohort of patients in its phase IIb clinical study of IMP321.

The study, dubbed AIPAC, is evaluating IMP321-plus-paclitaxel in hormone receptor-positive metastatic breast cancer.

According to the company, in the first six patients who received 6 mg doses of IMP321 in combination with paclitaxel, the dose has proved to be safe and well tolerated with no drug related serious adverse events.

The company will now start enrolling nine additional patients in the second cohort with 30 mg of IMP321, with the results of both cohorts to be presented and compared in the fourth quarter of 2016.

PBMD closed Tuesday's trading at $1.07, down 0.93%. In after hours, the stock was up 10.28% to $1.18.

RedHill Biopharma Ltd.'s (RDHL) phase I study of YELIVA in advanced solid tumors has successfully met its primary and secondary endpoints, demonstrating that the drug is well tolerated and can be safely administered to cancer patients at doses that provide circulating drug levels that are predicted to have therapeutic activity.

A phase I/II study with YELIVA for refractory or relapsed multiple myeloma is planned to be initiated in the coming weeks.

Another phase II study to evaluate YELIVA as a radioprotectant to prevent mucositis in cancer patients undergoing therapeutic radiotherapy is planned to be initiated in the second half of 2016 while a phase II study with YELIVA for the treatment of advanced hepatocellular carcinoma is planned to be initiated in the third quarter of 2016.

RDHL closed Tuesday's trading at $10.38, up 2.57%.