Below are companies which have either pending FDA decisions or pending 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.
A complete list of all headlines and biomedical stock developments can be found on BioMedReports.Com
On 7/7/09, Trinity Biotech (NASDAQ:TRIB) announced the FDA approval and U.S. launch of its high throughput haemostasis (blood clot) analyzer, the Destiny Max. On 9/3/09, TRIB announced the start of CLIA trials for its TRI-stat point-of-care HbA1c product, which is designed to measure HbA1c to assess a patient's average blood sugar control over the previous 2-3 months. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration required by three competing products. TRIB provided guidance that the trial would take about 4-6 weeks to complete at four locations at which point the data will be submitted to the FDA for CLIA approval.
On 6/7/09, Cubist Pharma (NASDAQ:CBST) announced that it began dosing in the CONSERV-2 clinical trial with ecallantide. CONSERV-2, being conducted in Europe, is a Phase 2 trial that will investigate ecallantide's effect on surgical blood loss volume in cardiac surgery patients who are on cardiopulmonary bypass and are at a high risk of bleeding. The trial is expected to enroll 300 subjects. Ecallantide is a potent inhibitor of plasma kallikrein, and CONSERV-2 will evaluate the effects of plasma kallikrein inhibition in the trial population. CBST stated that it remains on track for a mid-2010 end-of-phase 2 meeting with the FDA and anticipates that the results of this trial and the ongoing CONSERV-1 trial will provide meaningful insights into the optimal design of subsequent Phase 3 trials. In April 2008, Cubist announced an exclusive North American and European license and collaboration agreement with Dyax Corp. (NASDAQ: DYAX) for the development and commercialization of the intravenous formulation of ecallantide for surgical indications. The first indication being sought by Cubist for ecallantide is the reduction of blood loss during on-pump cardiac surgery.
On 7/07/09, NexMed, Inc. (NASDAQ:NEXM) announced the mutual decision with Novartis to terminate the licensing agreement for NM100060, a topically-applied treatment for onychomycosis, commonly known as nail fungus. NexMed entered into the exclusive, worldwide agreement with Novartis AG (NYSE:NVS) in September 2005, under which Novartis assumed all clinical development, regulatory, manufacturing and commercialization responsibilities for NM100060.
On 7/07/09 Amgen, Inc.(NASDAQ:AMGN) announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa(R) (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa.
Biotech investors interested in seeing the complete database of clinical trials and upcoming FDA decisions can access that information here:
http://biomedreports.com/fda-calendar/fda-calendar.html
Disclosure: No positions.
About BiomedReports.Com
BioMedReports.com is a news portal covering the biomedical news and financial sector. It features its own blog, discussion forum, stock research reports, news feeds, videos, press release capability, stock commentaries, and other unique content - including FDA and Clinical Trial Calendars plus a database that includes about 1,000 stocks and exchange-traded funds from the healthcare sector which are organized into various new healthcare stock indexes.
For more biomedical sector and investment news, go to www.BioMedReports.com
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