21.10.2015 10:34:04
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SNTA's GALAXY-2 Dies, NBIX For The Long Haul, VKTX Moving Ahead
(RTTNews) - Corbus Pharmaceuticals Holdings Inc.'s (CRBP) investigational new drug Resunab for the treatment of cystic fibrosis has been designated as a Fast Track development program and granted Orphan Drug Designation.
The company recently initiated an international, multi-center, phase II, double-blinded, randomized, placebo-control clinical study with multiple doses of Resunab in cystic fibrosis supported by a $5 million development award from Cystic Fibrosis Foundation Therapeutics, Inc. The study is designed to enroll approximately 70 adults with cystic fibrosis.
CRBP closed Tuesday's trading at $1.90, up 7.95%.
Foamix Pharmaceuticals Ltd. (FOMX) has enrolled the first patient in a phase II clinical trial of FMX103 for the treatment of papulopustular rosacea.
Papulopustular rosacea is a chronic skin disorder characterized by facial redness and inflammatory lesions. It affects more than 16 million people in the U.S. alone. The most common treatments for rosacea are topical therapies such as metronidazole and azelaic acid, as well as the oral antibiotics minocycline and doxycycline.
The phase II study is a 210 patient, double-blind, randomized placebo-controlled trial to be conducted in several sites throughout Germany. Foamix plans to support and expedite the filing of an NDA for FMX103 in the U.S. under the FDA's 505(b)(2) regulatory pathway.
FOMX closed Tuesday's trading at $7.15, down 4.03%.
Neurocrine Biosciences Inc. (NBIX) has initiated a phase II clinical trial of VMAT2 in adults with Tourette syndrome.
Tourette syndrome is a neurological disorder that consists of rapid, non-rhythmic stereotyped motor and vocal tics. Motor tics are typically characterized by facial grimacing, head jerks, extremity movements and other dystonic movements. Vocal tics typically include grunting, throat clearing, and repeating words and phrases.
The study is designed to enroll up to 90 adults and data readout from this study is expected later in 2016.
NBIX closed Tuesday's trading at $46.88, down 4.29%.
Shares of Synta Pharmaceuticals Corp. (SNTA) were down more than 46% in extended trading on Tuesday after the company decided to terminate a phase III trial evaluating its oncology drug candidate, Ganetespib in combination with a chemotherapy drug Docetaxel in patients with advanced non-small cell lung adenocarcinoma.
The decision to pull the plug on the trial, dubbed GALAXY-2, is based on the Independent Data Monitoring Committee's conclusion that the addition of Ganetespib to Docetaxel is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to Docetaxel alone.
SNTA closed Tuesday's trading at $2.04, up 0.99%. In after hours, the stock plunged 46.57% to $1.09.
Viking Therapeutics Inc. (VKTX) is all set to begin dosing hip fracture patients in a phase II efficacy trial of VK5211 this quarter, following successful completion of a short-term safety, tolerability, and pharmacokinetic study of VK5211 in healthy elderly subjects.
The study will enroll about 120 patients with the primary objective of determining the effects of VK5211 on lean body mass after 12 weeks of treatment.
Viking went public on April 29, 2015, offering its shares at a price of $8.00 each. The stock closed Tuesday's trading at $6.40, up 3.06%.
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Neurocrine Biosciences Inc. | 119,65 | -0,95% | |
Viking Therapeutics Inc | 44,23 | -3,66% |