Key Developments: Oncolytics Biotech Inc (ONCY.PH)

ONCY.PH on Philadelphia Stock Exchange

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30 Jun 2015
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Latest Key Developments (Source: Significant Developments)

Oncolytics Biotech receives orphan drug designation from U.S. FDA for Gastric Cancer
Wednesday, 6 May 2015 06:30am EDT 

Oncolytics Biotech Inc:Says 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 gastric cancers.  Full Article

Oncolytics Biotech announces receipt of orphan drug status from the EMA for Pancreatic Cancer
Wednesday, 29 Apr 2015 06:30am EDT 

Oncolytics Biotech Inc:Says the European Medicines Agency has granted Orphan Drug Designation for its lead product candidate, REOLYSIN, for the treatment of pancreatic cancer.  Full Article

Oncolytics Biotech Inc announces receipt of orphan drug designation from U.S. FDA for Malignant Gliomas
Friday, 17 Apr 2015 01:30am EDT 

Oncolytics Biotech Inc:Says U.S. FDA has granted an Orphan Drug Designation (ODD) for its lead product candidate, REOLYSIN.For treatment of malignant glioma.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.Says FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics.  Full Article

Oncolytics Biotech Inc announces filing for orphan drug designation with the U.S. FDA for Gastric Cancer
Tuesday, 7 Apr 2015 06:30am EDT 

Oncolytics Biotech Inc:Has submitted an application for Orphan Drug Designation to the U.S. Food and Drug Administration (FDA) for REOLYSINfor the treatment of gastric cancer.  Full Article

Oncolytics Biotech Inc announces receipt of Orphan Drug Status from EMA for Ovarian Cancer
Wednesday, 25 Mar 2015 06:30am EDT 

Oncolytics Biotech Inc:Announces that European Medicines Agency (EMA) grants Orphan Drug Designation for it's lead product candidate, REOLYSIN, for treatment of ovarian, fallopian tube and primary peritoneal cancers.  Full Article

Oncolytics Biotech Inc announces receipt of orphan drug designation from FDA
Tuesday, 3 Mar 2015 06:30am EST 

Oncolytics Biotech Inc:Says that U.S. Food and Drug Administration (FDA) has granted orphan drug designation for its lead product candidate, REOLYSIN, for treatment of primary peritoneal cancers.Says designation was granted on basis of company's Dec. 2014 application for an orphan drug designation encompassing ovarian, fallopian tube and primary peritoneal cancers which are generally treated as one indication.  Full Article

Oncolytics Biotech announces receipt of orphan drug designation from the U.S. FDA for cancer of Fallopian Tube
Monday, 2 Mar 2015 06:30am EST 

Oncolytics Biotech Inc:Says the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, REOLYSIN(®), for the treatment of cancer of the fallopian tube.Designation was granted on the basis of the company's Dec. 2014 application for an Orphan Drug Designation encompassing ovarian, fallopian tube and primary peritoneal cancers which are generally treated as one indication.  Full Article

Oncolytics Biotech Inc announces receipt of orphan drug designation from U.S. FDA for Pancreatic Cancer
Tuesday, 17 Feb 2015 06:30am EST 

Oncolytics Biotech Inc:Says U.S. Food and Drug Administration has granted Orphan Drug Designation for its lead product candidate, REOLYSIN, for the treatment of pancreatic cancer.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 pct of pancreatic cancers have activating Ras pathway mutations and/or over-expressions.  Full Article

Oncolytics Biotech Inc announces receipt of orphan drug designation from U.S. FDA for Ovarian Cancer
Wednesday, 11 Feb 2015 06:30am EST 

Oncolytics Biotech Inc:Says U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, REOLYSIN, for treatment of ovarian cancer.Oncolytics has supported two sponsored clinical studies assessing REOLYSIN in treatment of ovarian cancer.Says first was Phase 1/2 clinical trial (OSU-07022) for patients with metastatic ovarian, peritoneal and fallopian tube cancers using concurrent intravenous and intraperitoneal administration of REOLYSIN that provided evidence of viral targeting and replication in peritoneal and ovarian cancer cells.Second is an ongoing randomized Phase II trial (GOG186H) of weekly paclitaxel versus weekly paclitaxel with REOLYSIN in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer.Says second trial completed enrollment in Sept. 2014.  Full Article

Oncolytics Biotech Inc announces filing for Orphan Drug Designation with the U.S. FDA for High Grade Gliomas in Pediatric Patients
Monday, 9 Feb 2015 06:30am EST 

Oncolytics Biotech Inc:Says it has submitted an application for Orphan Drug Designation to the U.S. FDA for REOLYSIN for the treatment of high grade gliomas (HGG) in pediatric patients.Says it has conducted three previous clinical studies in brain cancers including gliomas, and has found that REOLYSIN can infect a variety of brain tumors when delivered intravenously.  Full Article

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