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. If you watch patterns, you've seen the same type of "bullish" insider buying activity take place on countless other occasions, but perhaps the most recent example comes from Human Genome Sciences (NASDAQ:HGSI) just days before news about BENLYSTA made shares jump significantly.

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. Multikine is the company's multi-targeted, cancer immunotherapy which performed well in Phase II, but had been sidelined while said laboratory was being built to accommodate the production of the sensitive and complex biologic drug candidate platform. Those looking for "tells," certainly point to news about the new laboratory as one such positive indicator. Would a publicly traded company spend a rumored $20-$25 million on a new lab to produce a  their cancer vaccine if they didn't have enough scientific proof that the drug would perform well in Phase III? The United States Food and Drug Administration (FDA) certainly concurred with the initiation of a global Phase III clinical trial in head and neck cancer patients using Multikine back in January 2007, so this development would qualify as long awaited good news for the stock. Upcoming news might also be related to the company's inclusion in the latest Vaccine Identification Standards Initiative. The office of the Chief Science Officer for the CDC has just added Cel-Sci to his comprehensive list of vaccine and biologics manufacturers and distributors. The company did not appear on documents previously released by the Centers for Disease Control and Prevention.

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. Marketing for such a drug is still some time away (perhaps 2012-2013) but it could bring over $1 billion in sales for the company and that makes it an attractive stock for longer term speculators.AVI Biopharma, Inc. (AVI) has also developed the treatments for a coronary artery blockage, and for Ebola and Marburg. These drugs are also in early-stage trials.  Barron's has published that it must be noted that AVI Biopharma, Inc. (AVII) has disappointed in the past, when its drug for hepatitis failed to pass the trials. The biopharmaceutical company specializes in the discovery and development of ribonucleic acid (RNA)-based drugs targeting a range of diseases.

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.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.

EpiCept Corporation (Nasdaq:EPCT) announces the release of new findings demonstrating the pharmacoeconomic benefits of Ceplene® (histamine dihydrochloride) for the remission maintenance of Acute Myeloid Leukemia (AML) patients in first remission.

SuperGen, Inc. (NASDAQ:SUPG) and GlaxoSmithKline (NYSE:GSK) have entered into a multi-year collaboration to discover and develop cancer therapeutics based on epigenetic targets.

Allergan, Inc. (NYSE:AGN) announced the United States District Court for the District of Delaware ruled in favor of Allergan, Inc. in its patent infringement suit against Exela PharmSci, Inc., Exela PharmSci Pvt., Ltd. ("Exela"), Apotex, Inc. and Apotex Corp. ("Apotex") (collectively, the "Defendants") for seeking to market purported generic versions of Allergan’s drugs ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% and 0.15%.

Inovio Biomedical Corporation (NYSE:INO), a leader in DNA vaccine design, development and delivery, announced its board of directors elected David J. Williams, former chairman and CEO of Sanofi Pasteur, the vaccine business of Sanofi-Aventis Group, and Keith H. Wells, a senior member of the Biologics Consulting Group and former director of vaccine development for The Salk Institute, to the board.

SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN) announced it plans to report third quarter 2009 results on Monday, November 9. SciClone will host a conference call to give a business and product update at 8:30 am ET that day.

EpiCept Corporation (Nasdaq:EPCT) announces the release of new findings demonstrating the pharmacoeconomic benefits of Ceplene® (histamine dihydrochloride) for the remission maintenance of Acute Myeloid Leukemia (AML) patients in first remission.

BIOLASE Technology, Inc. (NASDAQ:BLTI), the world's leading dental laser company, announced veteran public company board member and dental executive Gregory D. Waller has been named to its Board of Directors, effective immediately.

Shire plc (NASDAQ:SHPGY), the global specialty biopharmaceutical company, announces the Food and Drug Administration (FDA), following a thorough administrative review of governing statutory and regulatory standards and public comments, has affirmed its prior decision to grant five-year New Chemical Entity (NCE) exclusivity to lisdexamfetamine dimesylate-currently marketed by Shire U.S. Inc. for the treatment of attention-deficit hyperactivity disorder under the name VYVANSE(R).

Spectrum Pharmaceuticals, Inc. (Nasdaq:SPPI), a commercial-stage biotechnology company with a focus in oncology, announced an overview of the Company’s business strategy will be presented at the 2009 BIOCOM Investor Conference on Tuesday, October 27, 2009 at 9:30am Pacific Time.

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) announced the Company will report third quarter 2009 financial results following the close of the U.S. financial markets on Monday, November 9, 2009.

NanoViricides, Inc. (OTC:NNVC), reports the Company is well financed and its game changing anti-viral drug development programs are progressing successfully.

Speaking today in Barcelona at the Fifth Peptide Engineering Meeting, Compugen Ltd. (NASDAQ:CGEN) project manager Dr. Yossef Kliger provided an overview of Compugen’s DAC Blockers Platform and reviewed disease model data for selected product candidates.

Antigenics (NASDAQ:AGEN) announced the Brain Tumor Research Center at the University of California, San Francisco (UCSF), has presented an update on a Phase 2 clinical trial of Oncophage (vitespen) for recurrent high grade glioma (brain cancer) at the 2009 Joint Meeting of SNO (Society for Neuro-Oncology) and AANS/CNS Section on Tumors 2009 in New Orleans, LA. Data were presented in Sunrise Session #6: Immunotherapy: Current Status of Clinical Trials on Saturday, October 24.

SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN) announced it plans to report third quarter 2009 results on Monday, November 9.

Somaxon Pharmaceuticals, Inc. (NASDAQ:SOMX) announced Richard W. Pascoe, Somaxon’s president and chief executive officer, will present a company overview at the Oppenheimer 20th Annual Healthcare Conference at the Waldorf-Astoria Hotel in New York City on Wednesday, November 4th at 4:30 P.M. Eastern Time.

Rexahn Pharmaceuticals, Inc. (NYSE:RNN) announced it has completed its previously announced Registered Direct Offering of common stock and warrants.

Allos Therapeutics, Inc. (NASDAQ:ALTH), a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics,  announced Company management will provide a corporate update and review of the third quarter 2009 results via webcast and conference call on Tuesday, November 3, 2009, at 4:30 p.m. ET.

Idera Pharmaceuticals, Inc. (Nasdaq:IDRA) announced the issuance of patents covering its novel Toll-like Receptor (TLR) - targeted compounds. The Company's TLR-targeted compounds are based on synthetic DNA and RNA, which it refers to as immune modulatory oligonucleotides, or IMO®.

AVI BioPharma, Inc. (NASDAQ:AVII), a developer of RNA-based drugs, presented an update on preliminary safety data from its ongoing systemic Phase 1b/2 clinical trial of exon skipping AVI-4658 in patients with Duchenne muscular dystrophy (DMD) at the 7th Annual Action Duchenne Conference in London, UK.

Dyadic International, Inc. (OTC:DYAI) announced financial results for the first and second quarters of 2009 as well as for the years ended December 31, 2008 and 2007.

AMRI (NASDAQ:AMRI) announced it will issue third quarter financial results before the opening of the market on Monday, November 9, 2009. Following the release of its results, the company will host a conference call and simultaneous webcast at 10 a.m. EST.

Cannabis Science Inc. (OTC:CBIS) an emerging pharmaceutical cannabis company, is urging that US government recognize that phytocannabinoid pharmaceutical products can help reduce Adult Respiratory Distress Syndrome (ARDS)-associated deaths from both the Avian and Swine Influenza infections, as President Obama declares a national emergency.

Fero Industries, Inc. (OTC:FROI) is pleased to provide certain disclosures relating to the ten pending patent applications of Pyro Pharmaceuticals, Inc.

NPS Pharmaceuticals, Inc. (NASDAQ:NPSP) reported additional data from a Phase 3 study supporting the efficacy of GATTEX™ (teduglutide) in   patients with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).

CEL-SCI Corporation (AMEX:CVM) announced it has received over $10 million over the past 60 days through the exercise of warrants by investors to purchase the Company's common stock.

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) announces the 2009 American College of Gastroenterology (ACG) Annual Scientific Meeting will be the venue for 13 presentations describing the investigation of the Company’s bacterial-related disease, inflammatory bowel disease and bowel cleansing product lines.

Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announced it plans to report third quarter 2009 financial results on Thursday, November 5, 2009, following the close of market.

Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) reviewed recent business and clinical progress and reported consolidated financial results for the quarter ended September 30, 2009.

SuperGen, Inc. (NASDAQ:SUPG) reported financial results for the third quarter and nine months ended September 30, 2009.

Microfluidics International Corporation (OTC:MFLU) announced it has received a $1.0 million secured revolving line of credit from Webster Bank, N.A.

EastBridge Investment Group (OTC:BIG) announced its CEO, Keith Wong, has attended a land acquisition signing ceremony in Jiyuan, Henan for Alpha Green Energy Limited.

Inhibitex, Inc. (NASDAQ: INHX) announced a poster presentation describing preclinical data on INX-189, the lead compound from its HCV nucleotide polymerase inhibitor program, will be presented by Dr. Joseph M. Patti, Chief Scientific Officer and Senior Vice President of R&D, at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, MA.