|Stocks to Watch on Monday|
|By Staff and Wire Reports|
|Monday, 05 October 2009 02:48|
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.
Insiders at Cel-Sci Corporation (AMEX:CVM) had been buying shares at open market prices just days before a vastly under researched story hit the news wires on Friday. Rumors about the latest report filings with the SEC had begun to spread and had prices for shares significantly rising above market close last Thursday after hours, but enthusiasm for the stock was dampened when the hit piece from the Street.Com took aim at them.
Specific details about a number of upcoming catalysts have yet to be disclosed by the company, but readers of this space know that the Cel-Sci has several pending news items due, including the unveiling of their new state-of-the-art cold fill laboratory, any number of announcements regarding their newly (FDA) fast-tracked H1N1 flu treatment human studies as well as official news about the launch of Phase III studies for Multikine.
Another stock to watch is AVI BioPharma, Inc.(NASDAQ:AVII). The Wall Street Journal and other seem to have taken an interest, as the company's drug for the worst form of muscular dystrophy moves toward FDA approval. The stock could also surge if the company becomes an acquisition target.
Dr. Eric Hoffman, a leading Duchenne researcher at the Children's National Medical Center in Washington, said that he is very convinced this drug will work. Meanwhile, Prosensa, a Dutch company developed their own muscular dystrophy drug that is considered a promising treatment, alongside AVII's.
Finally, Inovio Biomedical Corporation (NYSE Amex: INO) announced interim safety and immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial and that could make it a big gainer. According to the company, the vaccine was found to be generally safe and well tolerated, and achieved significant cellular and humoral immune responses at the lowest dose administered. A news report about those newly reported findings can be read here.