AT-GAA is the first ever investigational product for Pompe disease to receive BTD.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
Shares are up 7% premarket.
Have you seen the article Forbes wrote about the ASDN Flying Passenger Drone and its technology?
Anixa Biosciences (NASDAQ:ANIX) has entered into a strategic alliance with ResearchDx to launch its Cchek Prostate Cancer Confirmation (Cchek PCC) test as a Laboratory Developed Test.
Cchek PCC is designed to confirm the presence of cancer in a preliminarily diagnosed patient prior to biopsy.
Once launched, Cchek PCC will be available throughout U.S., with the exception of New York state, which requires additional regulatory certification.
ResearchDx will begin clinical validation with the goal of launching the test in Q3.
Shares are up 3% premarket.
]]>