Viral Therapy For Cancer Gets FDA Nod, ARNA Slimming Down, ZLTQ Well-Sculpted

(RTTNews) - The FDA has approved Amgen Inc.'s (AMGN) IMLYGIC for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery.

IMLYGIC, which is the first oncolytic viral therapy to receive the regulatory nod, is expected to be available to patients in the U.S. within a week. Amgen anticipates the average cost of IMLYGIC therapy to be approximately $65,000.

IMLYGIC is also under review in the European Union. Last week, the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, adopted a positive opinion recommending that IMLYGIC be granted approval for the treatment of adults with advanced melanoma. A final decision of the European Commission is expected in the coming months.

Amgen is also evaluating IMLYGIC in combination with other immunotherapies in advanced melanoma and other solid tumors.

AMGN closed Tuesday's trading at $161.98, up 2.14%.

As part of improving efficiencies and reining in costs, Arena Pharmaceuticals Inc. (ARNA) will be reducing its U.S. workforce by approximately 80 employees or 35%, and implement additional cost control measures to further reduce its expenditures, including reductions at its Swiss manufacturing facility, Arena Pharmaceuticals GmbH.

The U.S. workforce reduction, which is expected to be completed by December 31, 2015, will result in restructuring charges, primarily in the fourth quarter of 2015, of approximately $3.3 million in connection with one-time employee termination costs, including severance and other benefits, according to the company.

ARNA closed Tuesday's trading at $2.20, down 0.45%.

Cytokinetics Inc. (CYTK) announced that COSMIC-HF, a phase II trial of Omecamtiv mecarbil in patients with chronic heart failure has demonstrated statistically significant improvements in several pre-specified measures of cardiac function.

According to the trial results, Omecamtiv mecarbil in patients with chronic heart failure, showed statistically significant improvements in systolic ejection time, stroke volume and N-terminal-pro-brain natriuretic peptide, at 20 weeks following randomization.

Omecamtiv mecarbil is being developed by Amgen Inc. (AMGN) in collaboration with Cytokinetics. Amgen holds an exclusive, worldwide license to Omecamtiv mecarbil and related compounds, subject to Cytokinetics' specified development and commercialization rights. Additionally, Les Laboratoires Servier obtained an exclusive option to commercialize Omecamtiv mecarbil in Europe.

CYTK closed Tuesday's trading at $77.18, down 3.20%.

Masimo Corp.'s (MASI) MightySat Rx, a fingertip pulse oximeter, has received FDA 510(k) clearance.

MightySat Rx is designed to comfortably grip a patient's finger using a flexible, conforming silicon pad. An organic light-emitting diode (OLED) display presents information clearly and a touchpad allows for customization. MightySat Rx is designed to be both rugged and lightweight. The device is available in three versions - MightySat Rx, MightySat Rx with Bluetooth LE, and MightySat Rx with Bluetooth LE & PVI.

MASI closed Tuesday's trading at $38.55, up 1.13%.

ZELTIQ (ZLTQ) has revised up its revenue forecast for the full year of 2015 to approximately $252 million from prior guidance of $245 million to $247 million.

For the just reported third quarter, the company's total revenue was $61.2 million compared to $45.7 million in the year-ago quarter.

ZLTQ closed Tuesday's trading at $35.37, up 3.54%. In after hours, the stock was up 2.63% to $36.30.