31.12.2014 05:12:26
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ARIA Widens Sales Turf, NRX Skips A Beat, NRDM Triples On Parkinson's Study
(RTTNews) - Aquinox Pharmaceuticals Inc. (AQXP) has initiated dosing in a phase II clinical trial of AQX-1125 for the treatment of atopic dermatitis.
The trial, dubbed KINSHIP, designed to enroll about 50 adult patients with mild to moderate atopic dermatitis is being conducted at clinical research centers in Canada.
AQXP closed Tuesday's trading 6.46% higher at $7.25.
ARIAD Pharmaceuticals Inc. (ARIA) has granted Angelini Pharma exclusive rights to commercialize leukemia drug Iclusig in seven Central and Eastern European countries.
The seven countries include Bulgaria, the Czech Republic, Hungary, Poland, Romania, Slovakia and Slovenia. The commercial launches of Iclusig in these Central and Eastern European countries are expected to begin in 2015.
With this distributorship in place, Iclusig will be available to patients with resistant and intolerant Philadelphia-positive leukemias in more than 23 countries in Europe.
Net product revenues from sales of Iclusig were $14.5 million for the quarter ended September 30, 2014, an increase of 22% from the second quarter of 2014.
ARIA closed Tuesday's trading at $6.82, down 1.23%. In after-hours, the stock was up 1.25% at $6.90.
Idera Pharmaceuticals Inc.'s (IDRA) drug candidate IMO-8400 has been granted orphan drug designation by FDA for the treatment of Waldenström's macroglobulinemia, a type of non-Hodgkin lymphoma.
IMO-8400 is currently under a phase 1/2 clinical trial in patients with Waldenström's macroglobulinemia who have a history of relapse or failure to respond to one or more prior therapies. The company expects final 24-week safety and clinical activity data from the trial in the second half of 2015.
IDRA closed Tuesday's trading at $4.36, down 3.00%.
Shares of NephroGenex Inc. (NRX) were up more than 118 percent in Tuesday's extended trading following successful completion of a thorough QT/QTc (TQT) cardiac safety study on the company's drug candidate Pyridorin.
Pyridorin is under phase III testing in patients with diabetic nephropathy.
A TQT study is a specialized clinical trial designed to assess whether an investigational drug has the potential to prolong the QT interval. Note that a prolonged QT interval increases the risk of sudden cardiac death and arrhythmias.
NRX closed Tuesday's trading at $4.65, down 1.90%. In after-hours, the stock was up 118.28% at $10.15.
NeuroDerm Ltd. (NDRM) surged more than 193% on Tuesday following encouraging topline results of a phase IIa pharmacokinetic study of its product candidates ND0612H and ND0612L for the treatment of Parkinson's disease.
According to the European Parkinson's Disease Association, people with Parkinson's have reduced levels of dopamine, a chemical messenger in the brain involved in coordinating the nerve cells and muscles which control movement.
Levodopa, which is converted into dopamine in the brain, is considered the gold standard treatment for Parkinson's. However, due to the short half-life of oral Levodopa, patients are required to take multiple doses daily. But steady Levodopa delivery can currently only be achieved after undergoing an invasive surgical procedure whereby a tube is permanently implanted into the duodenum, the upper part of the small intestine.
Given the fact that continuous, subcutaneous delivery of product candidates, ND0612H and ND0612L, led to clinically-significant plasma levodopa levels in the phase IIa study, the company expects the high dose version ND0612H to offer a simple and effective treatment option that will minimize the need for surgical intervention in advanced Parkinson's patients.
NeuroDerm expects to proceed with the clinical development of ND0612H and ND0612L in the United States and the European Union in 2015.
NeuroDerm went public as recently as November 14, 2014 priced at $10 per share. The stock closed Tuesday's trading at $18.14, up 193.53%.
Sucampo Pharmaceuticals Inc.'s (SCMP) New Drug Submission for AMITIZA for the treatment of chronic idiopathic constipation in adults and opioid induced constipation in adults with chronic non-cancer pain has been accepted for review by Health Canada.
The drug is already available in the U.S., Japan, U.K. and Switzerland, with over nine million prescriptions written in the US alone.
Sucampo has a global license, development, commercialization and supply agreement with Takeda Pharmaceutical Co. Limited for AMITIZA.
SCMP closed Tuesday's trading at $13.89, down 0.29%.
Synthetic Biologics Inc. (SYN) has initiated a phase 1b clinical trial of its drug candidate SYN-004 for the prevention of Clostridium difficile infection.
The company expects to report topline data from the phase 1b clinical trial and initiate a phase 2 SYN-004 clinical trial during the first quarter of 2015.
SYN closed Tuesday's trading 1.34% down at $1.47.
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