THRX Breathes Easy, POZN Pops, RNN Begins Anew, ARIA On The Move

(RTTNews) - Theravance Inc.'s (THRX) phase 2b study of its investigational drug TD-4208 has met the primary efficacy endpoint in patients with moderate to severe chronic obstructive pulmonary disease.

According to the study results, TD-4208 demonstrated statistically significant change from baseline in trough FEV1 (forced expiratory volume in one second) at the end of Day 7.

THRX closed Wednesday's trading at $36.62, down 2.12%. In after-hours, the stock rose 2.20% to $37.43.

Shares of POZEN Inc. (POZN) surged over 13 percent in after-hours on Wednesday after the company announced the signing of a licensing agreement with Sanofi (SNY) for the commercialization of PA8140/PA32540 Tablets in the U.S.

The NDA for PA8140/PA32540 is under FDA review and the regulatory agency's decision date is set for January 24, 2014.

POZEN is seeking FDA approval for PA8140/PA32540 for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.

Chelsea Therapeutics International Ltd. (CHTP) rose over 8 percent to $3.35 in extended trading on Wednesday with the FDA accepting the company's resubmitted NDA for NORTHERA for the treatment of symptomatic neurogenic orthostatic hypotension. The regulatory agency is scheduled to announce its decision on NORTHERA NDA on February 14, 2014.

Rexahn Pharmaceuticals Inc. (RNN) is all set to initiate a phase I clinical trial of RX-3117 in cancer patients during the fourth quarter of 2013. It was only last month that Teva Pharmaceutical Industries Ltd. (TEVA) announced its decision not to exercise its option to license RX-3117 from Rexahn.

Accordingly, the Research and Exclusive License Option Agreement for RX-3117 between Rexahn and Teva was terminated.

RNN closed Wednesday's trading at $0.40, up 2.25%. In after-hours, the stock was up 2.69% to $0.42.

Derma Sciences Inc. (DSCI) has acquired a 7.3% stake in Comvita Ltd (CVT) by making a strategic investment of $7.0 million. The investment supports further developing Comvita's Manuka honey business, according to Brett Hewlett, Comvita's chief executive officer.

DSCI closed Wednesday's trading 0.78% higher at $14.22.

Rockwell Medical Inc.'s (RMTI) second phase III efficacy study of its drug candidate Soluble Ferric Pyrophosphate, or SFP, dubbed CRUISE-2, for the prevention and treatment of iron deficiency anemia in end stage renal disease or ESRD patients has also met primary and key secondary endpoints.

The first phase III study for SFP, dubbed CRUISE-1, the results of which were reported in July of this year, had also met the trial goals.

The company believes that upon FDA approval, SFP will become the new standard of care in iron therapy.

RMTI closed Wednesday's trading 8.84% higher at $6.03.

ARIAD Pharmaceuticals Inc. (ARIA) said that its phase III trial evaluating Iclusig (ponatinib) in adult patients with newly diagnosed chronic myeloid leukemia has reached 50 percent patient enrollment.

An interim analysis of efficacy will be performed in the third quarter of 2014. Full patient enrollment of approximately 500 patients in the trial is anticipated by the end of 2013.

Iclusig is already approved to treat patients with chronic, accelerated, and blast phases of CML and Ph+ ALL whose leukemia is resistant or intolerant to a class of drugs called tyrosine kinase inhibitors.

ARIA closed Wednesday's trading 5.99% higher at $20.35.