Company Update (NASDAQ:ONCY): Oncolytics Biotech, Inc. (USA) Announces Receipt of Orphan Drug Status from the EMA for Ovarian Cancer


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 European Medicines Agency (“EMA”) has granted Orphan Drug Designation for its lead product candidate, REOLYSIN®, for the treatment of ovarian, fallopian tube and primary peritoneal cancers.

“This is the second jurisdiction where we have gained Orphan Designation for the use of REOLYSIN® in the treatment of these gynecological cancers and our first grant in the European Union,” said Dr.  Brad Thompson, President and CEO of Oncolytics. “We continue to secure Orphan Drug Designation for selected cancers as a way to support further development of REOLYSIN® in key jurisdictions globally.”

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(Original Source)

Shares of Oncolytics closed yesterday at $0.789. ONCY has a 1-year high of $2 and a 1-year low of $0.40. The stock’s 50-day moving average is $0.71 and it’s 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 90.1% 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 0.4% and 14.8% respectively. Messer has a success rate of 37.3% and is ranked #2317 out of 3546 analysts, while Maruoka has a success rate of 78.9% and is ranked #846.

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.

Stay Ahead of Everyone Else

Get The Latest Stock News Alerts