Arca Biopharma Inc (NASDAQ:ABIO) gets FDA Fast Track Designation for Gencaro, Shares Soar 22% |
![]() |
By Marilyn Mullen |
Monday, 13 April 2015 14:15 |
ARCA is expecting enrollment of about 200 patients in Phase 2B portion of trial that would be finished by 2016 end.
Michael R. Bristow, President and Chief Executive Officer of ARCA, opined that the Fast Track designation for Gencaro development program shows how vital is the requirement for advancements in treating a trial fibrillation in heart failure patients.
He added that the condition affects over 2.7 million people in United States with 250,000 to 500,000 new cases diagnosed each year. Bristow is of the view that it is an important chance for improving treatment options for heart failure patients.
The Fast Track drug development designation was done in FDA Modernization Act of 1997 for enhancing interactions with FDA during drug development.
Such a program makes it easy for scheduling meetings for seeking FDA input into development plans as well as priority review of New Drug Application (NDA) along with an option of submitting portions of NDA for review before submission of complete application as well as potential accelerated approval.
Atrial fibrillation is a common sustained cardiac arrhythmia and figures that such individuals globally in 2010 were 33.5 million. AF leads to more risk of morbidity as well as mortality because of stroke and impaired quality of life.
Shares of the company soared 22% to $1.02 on hefty volume of 6.42 million shares.
"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'. Add this page to your favorite Social Bookmarking websites ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() |