Oncolytics Biotech, Inc. (USA) (NASDAQ:ONCY), a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, announced that the European Medicines Agency (“EMA”) has granted Orphan Drug Designation for its lead product candidate, REOLYSIN®, for the treatment of pancreatic cancer.
“Our submission to the EMA included survival data from our single arm gemcitabine/REOLYSIN® (REO 017) clinical study in pancreatic cancer patients, which factored into their decision to grant us the designation,” said Dr.Brad Thompson, President and CEO of Oncolytics.
The EMA grants Orphan Designation to medicines intended to treat, prevent or diagnose life threatening and debilitating disease, with a prevalence no greater than five in 10,000 in the EU, and where no satisfactory method of treatment, prevention or diagnosis exists, unless the proposed medicine offers a significant benefit to those with the condition. Following Orphan Designation, sponsors can access a number of incentives including protocol assistance, market exclusivity for a ten-year period following approval and potential fee reductions. The receipt of Orphan Designation does not change the regulatory requirements or process for obtaining marketing approval. For more information, please visit: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000029.jsp.
REOLYSIN® is Oncolytics’ proprietary isolate of the reovirus. Its primary mode of activity is to infect and selectively target tumours with activating Ras pathway mutations and/or over-expressions of Ras pathway elements including, amongst others, EGFR, BRAF, and KRAS. Up to 70% of pancreatic cancers have activating Ras pathway mutations and/or over-expressions. (Original Source)
Shares of Oncolytics closed yesterday at $0.7061 . 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 $0.76 and its 200-day moving average is $0.65.
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 represents a potential upside of 112.4% 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 -0.5% and 17.1% respectively. Messer has a success rate of 34.8% and is ranked #2841 out of 3581 analysts, while Maruoka has a success rate of 85.0% and is ranked #701.
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.