News Flow Continues on NAVB; Shares Expected To Remain Firm

On Tuesday morning, Navidea Biopharmaceuticals (NASDAQ:NAVB) announced that it commenced enrollment of a Phase II trial for its radiopharmaceutical agent, NAV4694, which is being tested  as a diagnostic for Alzheimer’s Disease. Through PET imaging, the agent detects one of the indicators of Alzheimer’s advancement, cerebral β-amyloid plaque, and early results show that it may be an improvement over existing options due to decreased white-matter uptake and favorable specificity and sensitivity. The study compares scan results between healthy volunteers, aged patients, and patients who may have Alzheimer’s to insure the safety and efficacy of the imaging agent. Navidea hopes to begin a Phase III trial of the  agent in early 2013. NAV4694 is one of four agents in Navidea’s development program, lead by the radiotracing agent Lymphoseek, which recently saw a setback due to third-party manufacturing problems.
NAVB closed on Monday at $3.09 and is up 3% in early trading Tuesday morning on the enrollment news, and that the manufacturing issues could be  resolved sooner than expected, resulting in FDA approval.  After the stock’s big decline earlier  this month after FDA delayed approval of Lymphoseek, investors appear to be regaining confidence in the stock  (see PropThink’s story Monday). Analyst price targets range from $5.75 to $7.50 for NAVB following the commercialization setback on September 10th, but many expect a swift resolution with a strong rebound in stock price. Ladenburg Thalmann estimates peak Lymphoseek sales of around $450M, so  a quick response to the FDA on manufacturing issues and an indication that  approval could come later this year or early next year, would be a major positive for NAVB.