Actavis plc (ACT) announced that the New Drug Application for Levosert, an investigational hormonal intrauterine contraceptive for use by women to prevent pregnancy, has been accepted for review by FDA. The regulatory agency is expected to announce its decision on Levosert by February 28, 2015.
Actavis signed a partnership deal with Medicines360, a non-profit pharmaceutical company, for Levosert in June 2013. As part of the agreement, Actavis licensed the U.S. commercial rights for Levosert while Medicines360 retained rights to market the product in the U.S. public sector, including family planning clinics that provide services to low-income women.
ACT closed Monday's trading at $216.13, down 0.94%.
Anacor Pharmaceuticals Inc. (ANAC) has roped in Sandoz Inc., a Novartis company, to distribute and commercialize its recently approved toenail fungal infection medication - KERYDIN topical solution, 5%, in the United States.
The agreement with Sandoz entitles Anacor to upfront payments totaling $40 million and an additional milestone payment of $25 million is expected to be paid in January 2015.
ANAC closed Monday's trading at $16.91, up 6.76%.
Avanir Pharmaceuticals Inc. (AVNR) is all set to initiate a phase II study of AVP-786 as an adjunctive treatment of major depressive disorder during the third calendar quarter of 2014. This will be the company's first clinical study evaluating AVP-786 in patients.
AVNR closed Monday's trading at $5.32, down 1.30%. In after-hours, the stock was up 0.38% to $5.34.
Cancer Genetics Inc. (CGIX) has acquired privately held Gentris Corporation, a global provider of clinical pharmacogenomics solutions, next-generation sequencing, and biomarker testing.
The acquisition is expected to add approximately $5 million to $6 million in annual sales for Cancer Genetics, and its overall biopharma contract backlog is anticipated to increase to over $18 million.
CGIX closed Monday's trading at $10.12, up 5.91%. In after-hours, the stock rose another 1.28% to $10.25.
Dipexium Pharmaceuticals Inc. (DPRX) has initiated patient enrollment in the second of two pivotal phase III clinical trials evaluating its investigational broad-spectrum, topical antibiotic Locilex for the treatment of patients with mild infections of diabetic foot ulcers, or Mild DFI.
The phase III program includes two trials - OneStep-1 and OneStep-2 that will each enroll approximately 180 patients at 20 separate centers in the United States. The company expects to complete the OneStep trials in the first quarter of 2015.
DPRX closed Monday's trading 6.68% higher at $10.06.
Genocea Biosciences Inc. (GNCA) has started a phase II dose optimization trial for its immunotherapy candidate against herpes simplex-type 2, GEN-003. The phase II dose optimization study will enroll approximately 300 subjects from 17 institutions in the United States and will study six combinations of two antigen doses (30 micrograms or 60 micrograms) with each of three adjuvant doses (25 micrograms, 50 micrograms, or 75 micrograms) alongside a placebo.
The company expects interim results from the trial to be announced in the middle of 2015.
GNCA closed Monday's trading at $15, down 0.07%.
Regulus Therapeutics Inc.'s (RGLS) pre-clinical drug candidate RG-012 has secured FDA's orphan drug designation for the treatment of Alport syndrome, a life-threatening genetic kidney disease with no approved therapy.
The company expects to initiate a phase I clinical study of RG-012 for the treatment of Alport syndrome in the first half of 2015.
RGLS closed Monday's trading at $6.67, down 1.48%.
Shares of TG Therapeutics Inc. (TGTX) rose over 5 percent to $10.11 in extended trading on Monday, following promising results from a phase I study of its combination of investigational drugs - TG-1101 and TGR-1202 - in patients with advanced chronic lymphocytic leukemia and non-Hodgkin's lymphoma.
According to the trial results, the combination demonstrated compelling early activity with all the patients (100%) exhibiting significant nodal reduction with either a normalization of or =80% reduction in Blood Lymphocyte Count. The combination treatment was well tolerated with no dose-related increases in toxicity among patients treated to date, said the company.
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