AspenBio Pharma soars on FDA news
AspenBio Pharma, Inc. (Nasdaq: APPY) shares are soaring after the biotechnology company reported that it expects to complete the FDA requirements to receive regulatory clearance for its AppyScore medical device before the end of 2008. AppyScore is a blood-based screening test for appendicitis.
“This represents another major milestone in the advancement of our breakthrough screen test for appendicitis and demonstrates the strength of our initial clinical results and particularly the high sensitivity of AppyScore,” CEO Richard Donnelly said in a statement. “We expect the FDA 510(k) to be a faster and easier path for regulatory clearance and introduction of this product. Most importantly, it creates the possibility of being able to begin marketing the first version of this test in the United States and certain international markets in 2008.”
In morning trading, APPY shares are soaring 22.8%, or $2.20, at $11.85. Over the last 52 weeks, shares have ranged from $2.50 to $15.16.
