06.03.2015 03:16:57
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GALE On The Radar, CALA Surges After-Hours, Capricor Uplisted, CPRX On A High
(RTTNews) - Asterias Biotherapeutics Inc. (AST) has commenced enrollment for its phase 1/2a clinical trial of AST-OPC1 (oligodendrocyte progenitor cells) in newly injured patients with sensory and motor complete cervical spinal cord injury.
This trial follows the successful completion of a phase 1 trial of AST-OPC1, which met its primary endpoints of safety and feasibility when administered to five patients with neurologically complete, thoracic spinal cord injury.
AST closed Thursday's trading at $4.85, up 9.98%.
Shares of Calithera Biosciences Inc. (CALA) were up nearly 39% in extended trading after the company gained exclusive, worldwide license to TransTech Pharma's portfolio of hexokinase II inhibitors.
Hexokinase II is the first and rate-limiting enzyme in the pathway that enables cancer cells to convert glucose to energy and building blocks that feed cancer cell growth.
TransTech will receive an upfront payment from Calithera and will be eligible to receive future development and commercialization milestones as well as royalties on sales of approved products.
Calithera went public on the Nasdaq last October pricing its shares at $10 each. The stock closed Thursday's trading at $13.31, down 5.06%. In after-hours, the stock was up 36.66% to $18.19.
Catalyst Pharmaceutical Partners Inc. (CPRX) has been granted orphan drug designation by FDA for Firdapse for treatment of patients with Congenital Myasthenic Syndromes.
Catalyst licensed the exclusive North American rights to Firdapse from BioMarin Pharmaceutical Inc. (BMRN) in October 2012.
Firdapse previously received orphan drug designation in the U.S. and orphan medicinal product designation in the European Union for the treatment of Lambert-Eaton Myasthenic Syndrome ("LEMS").
Firdapse received European approval for symptomatic treatment in adults with LEMS in December 2009, and the drug is commercialized by BioMarin in the European Union.
CPRX touched a new 52-week high of $4.05 on Thursday before closing the day's trading at $4.04.
Capricor Therapeutics Inc. (CAPR.OB) is all set to begin trading its common stock on the NASDAQ Capital Market at the opening of market hours on Monday, March 9, 2015.
The company also announced that it is currently enrolling a phase II clinical trial with Cenderitide to treat heart failure. The present trial will enroll up to 14 patients with stable, chronic heart failure, added Capricor.
CAPR.OB closed Thursday's trading 36.75% higher at $8.00.
Galena Biopharma Inc. (GALE) has a number of clinical events stacked up for this year, and it may be worth putting this stock on your radar.
The company's phase 3 clinical trial evaluating NeuVax vaccine, dubbed PRESENT, to prevent or delay breast cancer recurrence after standard of care treatment (chemotherapy, hormone therapy, radiation therapy) , which has enrolled 700 patients, is expected to complete enrollment near the end of Q1, 2015.
Galena expects to reach its event-driven, interim analysis for the PRESENT trial at the end of 2015/early 2016 timeframe with a top-line data readout anticipated in 2018.
Dr. Reddy's, which holds the commercial rights for NeuVax in breast and gastric cancers in India, is expected to initiate a phase 2 clinical trial in gastric cancer in 2016.
Galena expects top-line data from a phase 2 study of GALE-401 in patients with myeloproliferative neoplasms by mid-year 2015.
GALE closed Thursday's trading at $2, up 2.56%. In after-hours, the stock was up another 4.50% at $2.09.
Prothena Corporation plc (PRTA) expects results from its phase 1 single ascending dose clinical study of Parkinson's disease drug candidate PRX002 in healthy subjects in March 2015, and data from a phase 1 multiple ascending dose clinical study in patients with Parkinson's disease in the first half of 2016.
The company expects to initiate a phase 1 single ascending dose trial of PRX003 in healthy volunteers in the first half of 2015, and a phase 1 multiple ascending dose study in patients with psoriasis in 2016.
PRTA closed Thursday's trading at $26.58, up 1.57%. In after-hours, the stock gained over 5% to $28.10.
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Biomarin Pharmaceutical Inc. | 62,00 | 0,55% | |
Catalyst Pharmaceutical Partners Inc. | 20,91 | -1,04% | |
Prothena Corporation PLC | 15,00 | 1,35% |