PETAH TIKVA (dpa-AFX) - ARCA biopharma Inc. (ABIO) has randomized the 100th patient in its phase 2B/3 clinical trial evaluating Gencaro as a potential treatment for atrial fibrillation.
The trial, dubbed GENETIC-AF, has now reached two-thirds of the minimum number of patients needed for a pre-specified efficacy analysis. The company expects to randomize at least 150 patients into the trial by the end of 2016, making the trial eligible to be subjected to an interim efficacy, safety and futility analysis by the Data Safety Monitoring Board.
The outcome of the interim analysis is anticipated in the second quarter of 2017.
ABIO closed Thursday's trading at $3.03, up 1.00%.
Shares of Auris Medical Holding AG (EARS) cratered over 59% on Thursday as the phase III trial of Keyzilen in acute inner ear tinnitus failed to meet its co-primary efficacy endpoints.
In the trial, dubbed TACTT2, the two co-primary efficacy endpoints of statistically significant changes in tinnitus loudness and tinnitus burden compared to placebo were not achieved.
Results from the second phase III trial, known as TACTT3, are expected in the fourth quarter of 2016.
A phase III trial of AM-111 for acute inner ear hearing loss, known as HEALOS, is underway, and results are expected in the second half of 2017.
EARS closed Thursday's trading at $2.15, down 59.81%.
Teva Pharmaceutical Industries Ltd. (TEVA) has received the European Commission's marketing authorization for CINQAERO as an add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
CINQAERO is currently approved and marketed in the United States and Canada as CINQAIR. The drug was approved in the U.S. in March, 2016 and in Canada last month.
Following the European Commission's approval, CINQAERO will be available in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland within the coming months.
TEVA closed Thursday's trading at $53.05, up 0.59%.
Copyright RTT News/dpa-AFX
© 2016 AFX News
