Anavex Life Sciences Corp. (NASDAQ:AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today reports the U.S. Food and Drug Administration’s (FDA) Office of Orphan Product Development (OOPD) has granted Orphan Drug Designation (ODD) to ANAVEX 2-73 for the treatment of Rett syndrome.
“The Orphan Drug Designation marks the first U.S. movement for ANAVEX 2-73. Rett syndrome is a devastating disease occurring in early childhood and almost exclusively in girls. As there is currently no cure and limited treatment, Rett syndrome represents a clear unmet clinical need,” commented Christopher U. Missling, PhD, President and Chief Executive Officer. “The acknowledgement from the Agency for this orphan designation allows us to formally move forward with the planned human clinical study in this disease indication, thereby potentially expanding the reach for ANAVEX 2-73 in addition to Alzheimer’s disease.”
The FDA’s Office of Orphan Products Development advances the evaluation of drugs that show promise for the safe treatment of rare diseases, defined as those 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. (Original Source)
Shares of Anavex Life are up nearly 4% to $4.30 in pre-market trading. AVXL has a 1-year high of $14.84 and a 1-year low of $1.32. The stock’s 50-day moving average is $5.12 and its 200-day moving average is $5.35.
On the ratings front, Anavex has been the subject of a number of recent research reports. In a report released yesterday, Maxim Group analyst Jason Kolbert reiterated a Buy rating on AVXL, with a price target of $15, which represents a potential upside of 261.4% from where the stock is currently trading. Separately, on May 18, FBR’s Christopher James reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Christopher James have a total average return of -16% and -17% respectively. Kolbert has a success rate of 28.1% and is ranked #3841 out of 3842 analysts, while James has a success rate of 24.2% and is ranked #3800.
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.