Dallas, Texas 12/09/2013 (Financialstrend) – Arca Biopharma Inc (NASDAQ:ABIO) which is responsible for developing genetically-targeted therapies for cardiovascular diseases recently announced that their Atrial Fibrillation treatment application has been accepted the US FDA and is now active. As per the biopharma company they wish to evaluate Gencaro as a potential treatment for Atrial fibrillation under their Phase 2B/3 GENETIC-AF clinical trial and patients will be enrolled for the treatment in the first quarter of 2014. To add further the company also said that they have identified common genetic variations that can predict individual patient response to Gencaro.
Arca Biopharma Inc (NASDAQ:ABIO) also believes that the Gencaro has the potential to be the first genetically targeted therapy for the prevention of Atrial fibrillation.
What does the future has stored for this stock?
Arca Biopharma Inc (NASDAQ:ABIO) also believes that the clearance by the DSMB around 2016 will make them proceed towards the phase 3 portion of the entire study and after another 30 months the next lot of 420 patients will get enrolled and they will be in a better position to report their top-line results. As per the news the phase 2 of the study will seek enrollment at around 50-60 centers in the US and out of these 50-60 centers almost 30-50 centers will come online once the DSMB will review them in the mid 2016.
All these things might lead to overall acceleration of the enrollment which will lead them towards 2018 and if all goes well according to the pre-designed plan the ACRA will be in a better position to re-file the NDA on bucindolol during the first half of 2019. Then the regulatory decision will come by late 2019 and people can expect the potential launch in 2020. All this seems to be in the favor of the ACRA biopharma.