Regulatory milestones
Highlights of weekly biotech stock moves
AspenBio Pharma Inc. (NASDAQ:APPY) fell $1.81 (54%) to $1.57 on Monday after the company delayed the submission of a 510(k) application for its AppyScore blood-based screen/triage test for acute appendicitis. The company said additional data analysis is necessary due to variability in results from site to site in the initial draft of the statistical analysis report. For the week, AspenBio was off $1.94 (57%) to $1.44.
Depomed Inc. (NASDAQ:DEPO) was off $0.34 (10%) to $2.98 last week after FDA accepted for review an NDA from partner Abbott Laboratories Inc. (NYSE:ABT) for DM-178 to manage post-herpetic neuralgia (PHN). The PDUFA date was not disclosed. The once-daily, extended-release formulation of gabapentin uses Depomed's Acuform delivery technology. Abbott has rights in the U.S., Canada and Mexico...