PhaseBio’s drug that aims to stop bleeding events received a breakthrough drug designation from the U.S. Food and Drug Administration. That follows an initial public offering and promising test results.
The recently announced designation expedites regulatory review of promising drugs targeting areas with high need.
It comes after phase 1 clinical trial results showed PhaseBio’s drug, PB2452, reversed antiplatelet activity — which raises the risk of spontaneous major bleeding — associated with ticagrelor, an AstraZeneca drug.
Ticagrelor is taken to prevent heart attack and stroke.
The company is headquartered in San Diego, with a large
research and development presence in Pennsylvania.
“Breakthrough Therapy designation supports our goal of making the first approved reversal agent for ticagrelor available to patients and physicians as soon as possible,” said John Lee, chief medical officer of PhaseBio, in a statement.
In October, the company went public with a $43 million offering. A month before the IPO, the company took in a $34 million Series D round. The investors included AstraZeneca.