Below are four companies with market caps under $200 million (all financial data current as of 6/9/09 during intraday trading) which have pending FDA decisions and/or clinical trial results that may have a major impact on each of the underlying stock prices. A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in Extreme FDA and Clinical Trial Calendar Trades, which are highlighted in periodic articles at BioMedReports.com. Another approach is to simply buy such companies well ahead of their expected catalyst dates for a possible stock price increase as the date approaches and trading activity increases.

1.) Angiotech Pharma [ANPI: 1.97, 0.00 (0.00%)] – currently trading at $2.14, market cap = $182 million

ANPI has an FDA-approved dialysis catheter (HemoStream) that is sold through its direct sales

As a trio of U.S. small-cap drug makers await crucial Phase 3 results later this year; NeuroSearch [NEUR: 0.00, N/A (N/A)] [NEUSF: 0.00, N/A (N/A)] is preparing to advance its own experimental weight loss drug to the final stage of clinical development following a successful End of Phase 2 meeting with the FDA which was announced earlier this week. Arena Pharma [ARNA: 4.99, +0.09 (+1.84%)], Vivus [VVUS: 6.04, +0.23 (+3.96%)], and Orexigen Therapeutics [OREX: 4.02, +0.06 (+1.52%)] are all awaiting Phase 3 clinical trial data expected during 3Q09 for their experimental weight loss drugs to support NDA filings for FDA approval, which are summarized and tracked in the BioMedReports.com FDA Calendar. 

On 6/8/09, NeuroSearch announced that it has successfully completed its End of Phase 2 meeting with the FDA for tesofensine, a monoamine reuptake inhibitor in development as

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of about 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following additional categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

On 6/4/09, Abbott Labs [ABT: 45.42, +0.86 (+1.93%)] and AstraZeneca [AZN: 43.34, +1.70 (+4.08%)] announced that the companies have submitted a New Drug Application (NDA) to the FDA for an investigational compound to treat mixed dyslipidemia, a combination of two

Emisphere [EMIS: 0.00, N/A (N/A)] is an emerging bio-pharma company specializing in the development of a drug delivery technology platform for the oral administration of therapeutic compounds which are either poorly absorbed or must be given through alternative routes such as injections.

On 6/1/09, EMIS announced that Novartis [NVS: 41.95, +1.66 (+4.12%)] and Nordic Bioscience have completed recruitment for the planned second multi-center Phase 3 study exploring the safety and efficacy of an oral formulation of salmon calcitonin using Emisphere’s proprietary Eligen Technology to treat patients with osteoarthritis of the knee. This study, which is intended to be used to support a FDA regulatory approval filing in the U.S., includes more than 900 patients between the ages of 51-80 with a medical history and symptoms of knee osteoarthritis. The study is being conducted in Europe and the U.S., as well as other countries, and is

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Clinical Data [CLDA: 11.83, -0.23 (-1.91%)] announced positive top-line results on 6/2/09 from the second of two Phase 3 trials of its investigational compound, vilazodone, for the treatment of major depressive disorder (MDD). In the study, vilazodone achieved statistically significant results on the primary

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Allos Therapeutics [ALTH: 7.19, -0.13 (-1.78%)]: On 5/30/09 , ALTH updated data from the Company’s pivotal Phase 2 PROPEL study of pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The overall response rate for pralatrexate as evaluated by central independent

In response to BioMedReports.com subscriber emails, we will add periodic article coverage of emerging small/micro-cap companies outside of the healthcare sector which offer similar high risk/reward trades as the Extreme Trade article series of pending FDA decisions and clinical trial results.

Options Media Group [OPMG: 0.00, N/A (N/A)] is a leading company in the fast-growing Email Service Provider (ESP) space which offers its clients a full array of direct, mobile, digital, and Internet marketing solutions with the ability to create, execute, and track e-marketing campaigns to a highly targeted audience. Services include email marketing, mobile (SMS or text messaging) marketing, SMS keyword marketing, and custom lead generation as a full-service marketing solution focused on new media outreach which is more targeted and effective than traditional outlets such as print, television, and radio.

In mid-May, OPMG released its 1Q09 operating results, which included revenue

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

On 5/28/09, Incyte Corp. [INCY: 3.64, +0.06 (+1.68%)] announced that based on recent input from the FDA regarding the Company’s request for a Special Protocol Assessment (SPA) for INCB18424 for patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis

The cancer biotech space has attracted the interest of investors, traders, and diversified healthcare giants this year with Johnson & Johnson [JNJ: 55.50, +0.34 (+0.62%)] announcing a $1B cash tender offer for Cougar Biotech [CGRB: 42.87, -0.12 (-0.28%)] last week and Roche’s [ROG: 17.67, +0.61 (+3.58%)] [RHHBY: 0.00, N/A (N/A)] mega-deal to acquire full control of Genentech earlier this year. In addition, positive clinical trial results for Dendreon’s [DNDN: 23.2099, +0.5399 (+2.38%)] Provenge and stock price turnarounds from the brink of zero at Cell Therapeutics [CTIC: 1.60, +0.17 (+11.89%)] have fueled interest in the small and micro-cap cancer bio-pharma space among investors and traders looking for the next big trade.

Access Pharma [ACCP: 0.00, N/A (N/A)] is an emerging bio-pharma company which is focusing on the development of a late-stage, diversified oncology pipeline in addition to

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.  

On 5/19/09, Biogen [BIIB: 50.69, +0.30 (+0.60%)] and Genentech (acquired by Roche) [RHHBY: 0.00, N/A (N/A)] announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the FDA for Rituxan (rituximab) plus standard chemotherapy for people with