ACT Gets It Right, CPRX On The Move, HALO Shines, Keep Watch On GALT, INSM

(RTTNews) - The FDA has approved Actavis plc's (ACT) Metronidazole 1.3% Vaginal Gel, an antibiotic, for the treatment of bacterial vaginosis. Actavis acquired the rights to Metronidazole 1.3% from Valeant Pharmaceuticals International Inc. (VRX) in April 2013.

Bacterial vaginosis is an infection caused by an imbalance in the normal bacteria in the vagina. It is the most common vaginal infection in women ages 15 to 44.

Metronidazole 1.3% Vaginal Gel is expected to be launched later this year.

ACT closed Tuesday's trading at $206.27, down 0.01%.

Actinium Pharmaceuticals Inc. (ATNM.OB) will commence trading its common shares on the NYSE MKT beginning on March 26, 2014.

The company's principal product candidates include Actimab-A, a phase I/II clinical trial monoclonal antibody for the treatment of acute myeloid leukemia in elderly patients, and Iomab-B that has completed a phase I/II design trial used to condition the bone marrow of patients by destroying blood cancer cells in their bone marrow.

ATNM rose 37.97% to $11.30, closing at an all-time high.

Catalyst Pharmaceutical Partners Inc.'s (CPRX) ongoing pivotal phase III clinical trial evaluating its experimental drug Firdapse for the treatment of Lambert-Eaton Myasthenic Syndrome will continue as planned, following the recommendations of the independent Data Monitoring Committee.

The trial is being conducted at 22 centers in the United States, Canada, South America and Europe.

CPRX closed Tuesday's trading 3.51% higher at $2.36.

Exelixis Inc.'s (EXEL) phase III pivotal trial of Cabozantinib in prostate cancer has been recommended by Independent Data Monitoring Committee to proceed to final analysis. Accordingly, the company anticipates top-line data from this trial in 2014.

The trial, dubbed COMET-1, is evaluating the company's drug Cabozantinib against corticosteroid Prednisone in men with metastatic castration-resistant prostate cancer previously treated with Docetaxel and Abiraterone or MDV3100.

Cabozantinib is currently approved in the U.S. and the European Union for the treatment of progressive, metastatic medullary thyroid cancer, and is marketed under the trade name Cometriq.

EXEL closed Tuesday's trading at $6.44, up 2.71%. In after-hours, the stock gained 1.24% to $6.52.

Galectin Therapeutics (GALT) will report results from the first cohort of its phase I clinical trial examining GR-MD-02 in fatty liver disease with advanced fibrosis on March 31, 2014.

The first-in-man study, which enrolled eight patients in the first cohort, is evaluating the safety, tolerability, and exploratory biomarkers for efficacy for single and multiple doses of GR-MD-02 when administered to patients with fatty liver disease with advanced fibrosis.

GALT rose 8.84% on Tuesday to close at $15.88. In after-hours, the stock was down 0.19% to $15.85.

Halozyme Therapeutics Inc.'s (HALO) phase 1/2 clinical trial evaluating the use of HTI-501 in the treatment of cellulite has met the primary endpoint, demonstrating its efficacy as a potential treatment for cellulite.

HALO closed Tuesday's trading at $12.61, up 1.20%. In after-hours, the stock was up 3.09% to $13.

Insmed Inc. (INSM) is scheduled to announce results from its U.S. phase II clinical trial of its experimental drug ARIKAYCE, or liposomal amikacin for inhalation, to treat nontuberculous mycobacteria (NTM) lung infections on Wednesday, March 26, 2014.

ARIKAYCE has Qualified Infectious Disease Product and Fast Track Designations from FDA for the treatment of NTM lung infections.

INSM closed Tuesday's trading at $18.30, down 1.56%. The stock gained 6.83% to $19.55 in extended trading.