Resverlogix's apadetalone nabs accelerated review in U.S.; shares up 15%

The FDA has granted Breakthrough Therapy status to Resverlogix's (OTCPK:RVXCF +14.8%) apabetalone (RVX-208), combined with standard-of-care treatment, including high-intensity statins, for the secondary prevention of major adverse cardiac events in patients with type 2 diabetes and recent acute coronary syndrome.

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.

Apabetalone works via an epigenetic mechanism called BET (bromodomain and extra-terminal) inhibition which regulates disease-causing genes. It specifically inhibits the second bromodomain (BD2) within the BET protein called BRD4, thereby producing a potential treatment benefit in patients with CV disease, diabetes, chronic kidney disease, Alzheimer's and other conditions.