Oncolytics Biotech, Inc. (USA) (NASDAQ:ONCY), a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) for its lead product candidate, REOLYSIN®, for the treatment of malignant glioma. The Company applied for an ODD for pediatric high grade gliomas (HGG), however the FDA granted an ODD for the broader indication of malignant glioma in patients of all ages. In three previous brain cancer studies including gliomas, REOLYSIN®has been shown to infect a variety of brain tumors when delivered intravenously.
“The focus of our Orphan Drug submissions has been on difficult to treat cancers where patients have few effective treatment options,” said Dr. Brad Thompson, President and CEO of Oncolytics. “Pediatric patients with high grade gliomas have particularly poor expected outcomes. We believe these patients, along with the adult population affected by malignant gliomas, would benefit from having additional treatment options.”
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:http://www.fda.gov/forindustry/DevelopingProductsforrareDiseasesConditions/default.htm.
According to the Central Brain Tumor Registry of the United States (CBTRUS), in 2015, an estimated 68,470 new cases of primary malignant and non-malignant brain and central nervous system tumors will be diagnosed of which 23,180 estimated new cases will be primary malignant tumors and 4,620 estimated new cases will be diagnosed in pediatric and adolescent patients. The CBTRUS estimates that the broad category glioma represents approximately 80% of malignant tumors and in patients between zero and 19 years of age, the overall total incidence of HGG (including anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, mixed glioma, and malignant glioma) is approximately 0.8 per 100,000. (Original Source)
Shares of Oncolytics closed yesterday at $0.6901 . ONCY has a 1-year high of $1.69 and a 1-year low of $0.40. The stock’s 50-day moving average is $0.80 and its 200-day moving average is $0.63.
On the ratings front, Oncolytics 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 implies an upside of 117.4% from current levels. 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 15.9% respectively. Messer has a success rate of 33.3% and is ranked #2916 out of 3573 analysts, while Maruoka has a success rate of 80.0% and is ranked #770.
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.