Medical device company Akers Biosciences Inc. (AKER) touched a 52-week high on Monday after announcing that it has added six new distributors to market its rapid tests for heparin-induced thrombocytopenia in nine additional countries within Europe, the Middle East and Africa.
AKER closed Monday's trading 8.70% higher at $5.00. In after-hours, the stock was up another 4% at $5.20.
ARCA biopharma Inc.'s (ABIO) lead product candidate, Gencaro, has received fast track designation from the FDA for the prevention of atrial fibrillation/atrial flutter in a genetically modified heart failure population (heart failure patients with reduced left ventricular ejection fraction.
A phase 2B/3 clinical trial, dubbed GENETIC-AF, evaluating Gencaro as a potential treatment for atrial fibrillation is underway. The company anticipates that the enrollment of 200 patients for the phase 2B portion of the trial may be completed by the end of 2016.
ABIO closed Monday's trading 13.35% higher at $0.95.
Arrowhead Research Corp. (ARWR) has received permission from the FDA to proceed with a multiple-dose phase 2b clinical study of ARC-520, its clinical candidate for the treatment of chronic hepatitis B infection.
The phase 2b study is planned to enroll up to 12 patients who will be randomized at a ratio of 2:1 with 8 patients receiving 1 mg/kg of ARC-520 and 4 patients receiving placebo. Each patient will receive 3 total doses, once every 4 weeks. Patients will be followed through Day 147.
ARWR closed Monday's trading at $8.00, up 1.14%.
Shares of Cipher Pharmaceuticals Inc. (CPHR) surged more than 21% on Monday as investors cheered the news of the company's acquisition of INNOCUTIS Holdings LLC, the licensee of Sitavig, a treatment for recurring Herpes Labialis, in the U.S.
Sitavig was launched in the U.S. by INNOCUTIS in July 2014 and Cipher plans to file it in Canada in 2016, enlarging the product's potential.
OnxeoS.A. and INNOCUTIS have a license agreement related to commercialization of Sitavig in the U.S., Canada, and Mexico.
CPHR closed Monday's trading at $11.75, up 21.25%.
Corbus Pharmaceuticals Holdings Inc.(CRBP.OB) is all set to be uplisted to The NASDAQ Capital Market on April 16, 2015, under its existing ticker symbol CRBP.
The company has plans to initiate a phase 2 clinical study of its lead product candidate, Resunab, in diffuse cutaneous systemic sclerosis and submit a phase 2 protocol for the treatment of cystic fibrosis in the second quarter of 2015.
CRBP.OB closed Monday's trading 16.90% higher at $3.39.
Shares of GW Pharmaceuticals plc (GWPH) rose more than 5% on Monday following encouraging new data on the company's investigational medicine, Epidiolex (pure cannabidiol or CBD), in the treatment for children with severe epilepsy that is not responding to other treatments, published by the American Academy of Neurology, or AAN.
In the study that involved participants ranging from toddlers to adults, the number of seizures decreased by an average of 54 percent in the 137 people who completed the 12-week study of Epidiolex.
Among the 23 people with Dravet syndrome who finished the study, the number of convulsive seizures had gone down by 53%, and for the 11 people with Lennox-Gastaut syndrome who finished the study, there was a 55% reduction in the number of atonic seizures, which cause a sudden loss of muscle tone, according to the the AAN release. Dravet syndrome and Lennox-Gastaut syndrome are types of epilepsy that can lead to intellectual disability and lifelong seizures.
GWPH closed Monday's trading at $96.18, up 5.32%.
RTI Surgical Inc. (RTIX), a surgical implant company providing surgeons with safe biologic, metal and synthetic implants, touched a 52-week high on Monday after announcing a new agreement with Novation, a leading health care services company. The agreement covers RTI's full line of surgical specialties implants and is effective starting April 1, 2015.
RTIX closed Monday's trading at $5.64, up 0.71%.
The trial date for two pending patent infringement cases against Roxane Laboratories Inc filed by Vanda Pharmaceuticals Inc. (VNDA) related to Fanapt, an antipsychotic drug for patients with schizophrenia, is set for February 29, 2016.
Roxane Labs is seeking to sell a generic version of Vanda's Fanapt whose patents are said to expire in November 2016 and November 2027.
Fanapt, which was approved by the FDA in May 2009, was commercially launched in January 2010. The U.S. and Canada rights to the drug were sublicensed to Novartis (NVS) in October 2009, and reacquired by Vanda in December 2014.
VNDA closed Monday's trading at $9.57, up 0.53%.
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