Anavex Life Sciences Corp. (NASDAQ:AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ANAVEX 3-71 for the treatment of Frontotemporal dementia (FTD).

Frontotemporal dementia describes a clinical syndrome associated with progressive shrinking of the frontal and temporal anterior lobes of the brain.  It causes a decline in language and/or behavioral changes, which include inappropriate social conduct, lack of empathy, blunted emotions or agitation, neglect of personal hygiene and a decrease in energy and motivation.  To date, no treatment has been shown to slow its progression and the prognosis for people with FTD is poor.  FTD afflicts an estimated 50,000 to 60,000 patients in the United States and represents an estimated 10 to 20 percent of all dementia cases.

“We believe that Orphan Drug Designation for ANAVEX 3-71 for the treatment of Frontotemporal dementia is a significant achievement,” said Kristina M. Capiak, Vice President of Regulatory Affairs at Anavex.

FDA Orphan Drug Designation is evaluated for drugs from all classes that are intended for the treatment of rare diseases, defined as diseases affecting fewer than 200,000 people in the United States.  The designation provides sponsors with development and commercial incentives, including seven years of market exclusivity in the U.S., prioritized consultation by FDA on clinical studies and certain exemptions from or reductions in regulatory fees.

“This regulatory milestone allows us to continue to advance in the rare disease space while expanding our portfolio within neurodegenerative diseases,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. (Original Source )

Shares of Anavex Life Sciences are up nearly 18% to $6.25 in pre-market trading Friday. AVXL has a 1-year high of $14.84 and a 1-year low of $1.02. The stock’s 50-day moving average is $4.75 and its 200-day moving average is $5.90.

On the ratings front, Anavex has been the subject of a number of recent research reports. In a report issued on March 29, FBR analyst Christopher James initiated coverage with a Buy rating on AVXL and a price target of $10, which implies an upside of 88.0% from current levels. Separately, on March 14, Maxim Group’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $15.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Christopher James and Jason Kolbert have a total average return of -5.9% and -13.1% respectively. James has a success rate of 43.1% and is ranked #3391 out of 3780 analysts, while Kolbert has a success rate of 32.1% and is ranked #3775.

Anavex Life Sciences Corp. is a biopharmaceutical company. It is engaged in the discovery and development of new drugs for the treatment of neurological diseases and cancer, utilizing its proprietary drug discovery sigmaceptor platform. The company’s portfolio comprises novel, wholly owned sigma receptor agonists and antagonists. Anavex Life Sciences was founded by Harvey Lalach and Athanasios Skarpelos on January 23, 2004 and is headquartered in New York, NY.