ATNM Marches Ahead, Good News From CDNA, It's Twofer For DEPO, INFI Reaches Mark

(RTTNews) - Shares of Actinium Pharmaceuticals Inc. (ATNM) were up 22% in extended trading on Tuesday, with the company gearing up for a phase III trial of its product candidate Iomab-B in refractory and relapsed Acute Myeloid Leukemia patients over the age 55. An Investigational New Drug application for Iomab-B was submitted to the FDA in this regard.

The trial will enroll 150 patients with 75 patients per arm, and the primary endpoint is durable complete remission, defined as a complete remission lasting at least 6 months and the secondary endpoint will be overall survival at one year.

ATNM closed Tuesday's trading at $2.20, up 1.38%. In after hours, the stock was up another 22.27% at $2.69.

BrainStorm Cell Therapeutics Inc. (BCLI), which has completed enrollment in its phase II clinical trial of its product candidate NurOwn for the treatment of patients with amyotrophic lateral sclerosis, anticipates reporting top-line results from the trial prior to the end of the second quarter of 2016.

BCLI closed Tuesday's trading at $2.71, down 1.81%.

There is good news for CareDx Inc. (CDNA) regarding its FDA-cleared diagnostic test AlloMap, which measures gene expression levels to help clinicians determine a heart transplant recipient's risk for organ rejection.

The Centers for Medicare and Medicaid Services, or CMS, is not going to implement its proposed 77% cut in reimbursement for AlloMap, which otherwise would have reduced the payment rate to $644.62 from $2,821.00.

With the CMS reversing its proposal, the payment rate for AlloMap remains at $2,821, which is the same as the existing rate set by a number of Medicare Administrative Contractors (MAC) including Noridian Administrative Services, Cigna Governmental Services.

Had the proposal not been reversed, it would have threatened the viability of CareDx as a business, and the only alternative for heart transplant patients would have been biopsy -- more invasive, more stressful, and more expensive to Medicare and taxpayers, since it is a procedure performed in a hospital, according to the company.

CDNA closed Tuesday's trading at $4.90, down 1.01%.

Depomed Inc. (DEPO) has entered into a definitive agreement to acquire the U.S. and Canadian rights to phase 3-ready Cebranopadol and its related follow-on compound from Grünenthal GmbH.

Depomed anticipates advancing Cebranopadol into phase III development for chronic lower back pain and other pain indications by 2017.

The deal with Grünenthal GmbH has also resulted in settlement of Depomed's ongoing patent litigation against Endo Pharmaceuticals for alleged infringement of three of Depomed's patents by Endo's OPANA ER product. The reason is Grünenthal is the formulator of OPANA ER.

DEPO closed Tuesday's trading at $19.12, down 1.39%. In after hours, the stock was up 4.29% at $19.94.

Infinity Pharmaceuticals Inc. (INFI) has reached target enrollment of 300 patients in DUO, a randomized phase III monotherapy study evaluating the safety and efficacy of Duvelisib compared to GlaxoSmithKline's approved chemotherapy drug Ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia.

The company recently completed patient enrollment in DYNAMO, a global, phase 2 open-label, single-arm, monotherapy study of duvelisib in approximately 120 patients with indolent non-Hodgkin lymphoma (iNHL) whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy.

INFI closed Tuesday's trading at $8.09, up 5.34%.

Radius Health (RDUS) has filed a Marketing Authorization Application for its investigational drug Abaloparatide-SC for the treatment of postmenopausal osteoporosis in Europe.

However, in the U.S., the submission has been delayed as the company now plans to submit the NDA for Abaloparatide-SC only by the end of the first quarter of 2016. The NDA was initially expected to be submitted in the second half of 2015.

RDUS closed Tuesday's trading at $61.51, down 11.09%.

Viking Therapeutics Inc. (VKTX) has submitted an investigational new drug application to the FDA to conduct a phase 2 study of VK2809 in patients with hypercholesterolemia and fatty liver disease.

The company expects to initiate the phase 2 clinical trial by the end of 2015, and complete it in 2016.

Early this month, the company initiated a phase II trial of trial of VK5211 in patients recovering from hip fracture.

Viking went public as recently as April 29, 2015, priced at $8.00 per share. The stock closed Tuesday's trading at $5, unchanged from the previous day's close.

Zoetis Inc.'s (ZTS) Simparica chewable tablets, a once-monthly medication for the treatment of fleas, ticks and sarcoptic mange in dogs beginning at eight weeks of age has been approved by the European Commission.

The company expects to launch Simparica in the EU in the first quarter of 2016. Simparica chewable tablets will be available in 5 mg, 10 mg, 20 mg, 40 mg and 80 mg dosage strengths.

ZTS closed Tuesday's trading at $45.77, up 1.04%.