Oncolytics Biotech, Inc. (NASDAQ:ONCY) makes our list of stocks to watch after reaching an agreement with the U.S. Food and Drug Administration under the special protocol assessment process for the design of a Phase 3 trial examining REOLYSIN in head and neck cancers.
On Friday, Oncolytics said it's the first company to reach an agreement with the FDA on a Phase 3 trial design for an IV-administered oncolytic virus under the SPA process. The SPA is an agreement between Oncolytics and the FDA that the design and planned analyses of the Phase 3 study is adequately designed to provide the necessary data. The stock traded above it's 52-week high on Friday, but shares ticked down a bit after hours. As news spreads about this key development, interest in the company may rise as well since a license application submission for REOLYSIN would become a major development for the Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics.
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