Oncolytics Biotech,® Inc. (USA) (NASDAQ:ONCY) announced that it has submitted an application for Orphan Drug Designation to the U.S. Food and Drug Administration ("FDA") for REOLYSIN® for the treatment of gastric cancer.
"Patients diagnosed with later stage gastric cancer generally have very poor prognoses," said Dr. Brad Thompson, President and CEO of Oncolytics. "As a result, gastric cancer is a serious issue both in the United States and other countries around the world including Japan and Korea where incidence rates are higher."
The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval. For more information, please visit:
The American Cancer Society estimates that 24,590 Americans will be diagnosed with gastric (stomach) cancer and an estimated 10,720 Americans are expected to die from the disease in 2015. The relative five-year survival rate for all stages combined is approximately 28 percent. (Original Source)
Shares of Oncolytics Biotech closed yesterday at $0.73 . ONCY has a 1-year high of $1.90 and a 1-year low of $0.40. The stock's 50-day moving average is $0.79 and it's 200-day moving average is $0.63.
On the ratings front, Oncolytics Biotech (NASDAQ: ONCY) has been the subject of a number of recent research reports. In a report issued on March 18, Needham analyst Chad Messer reiterated a Buy rating on ONCY, with a price target of $1.50, which represents a potential upside of 105.5% from where the stock is currently trading. Separately, on March 17, Canaccord Genuity's Neil Maruoka 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, Chad Messer and Neil Maruoka have a total average return of -1.0% and 12.7% respectively. Messer has a success rate of 32.4% and is ranked #2889 out of 3568 analysts, while Maruoka has a success rate of 78.9% and is ranked #959.
Oncolytics Biotech Inc is a development stage biopharmaceutical company. It is engaged in the discovery and development of pharmaceutical products for the treatment of cancer.