Below is a sample of entries from the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The companies outlined below have expected FDA new drug product decisions or clinical trial results expected over the next three months of summer. The list also includes some
Extreme Trades of companies with market caps below $250 million that have pending clinical trial results or FDA decisions that could have a major stock price impact.
Rigel Pharma (NASDAQ:RIGL): On 5/5/09, RIGL reported its quarterly financial results and stated that the Company expects to deliver top-line results in July 2009 from its TASKi2 and TASKi3 Phase 2b clinical trials, which add over 670 additional patients studied with lead compound R788 (given by oral administration) in rheumatoid arthritis (many of the treatments for this condition are given by injection which is not a popular route of administration) to the 189 patients studied from the Company's Phase 2a trial results reported in December 2007 (check out a two-year stock price chart to see the major upside impact of these results).
On 6/1/09, RIGL announced that its oral Syk inhibitor, R788, is also being evaluated in a Phase 2 clinical trial funded, designed and implemented by the National Cancer Institute (NCI), part of the U.S. National Institutes of Health. This open-label, single arm clinical trial will include patients with advanced colorectal, thyroid, non-small cell lung, hepatocellular, head and neck, or renal cell cancers who have failed to respond to at least one line of therapy. In addition, the company has an ongoing Phase 2 clinical trial of R788 in patients with peripheral T-cell lymphoma and reported favorable results from a Phase 2 clinical trial of R788 in the treatment of patients with certain B-cell lymphomas in June 2008.
Aeterna Zentaris (NASDAQ:AEZS): On 6/15/09, AEZS reported that patient follow-up in the open-label safety study (study 041) of its Phase 3 program in benign prostatic hyperplasia (BPH) with its lead endocrinology compound, cetrorelix pamoate, is scheduled to be completed at the end of the week. Therefore, data analysis and reporting will be brought forward from the scheduled fourth quarter into the third quarter of 2009, and will follow the disclosure of results from the first double-blind placebo controlled efficacy study (study 033).
Cetrorelix is currently in three Phase 3 trials involving more than 1,600 patients with symptomatic BPH in Canada, the United States and Europe. First efficacy results are expected during 3Q09 with a NDA filing targeted in 2010. AEZS has also announced recently that patients completing two years of therapy with cetrorelix in the first efficacy study (study 033), will be eligible to continue with the cetrorelix treatment, according to treatment regimen of the ongoing Phase 3 study, until the end of 2011. Patients entering this extension study sponsored by the Company's partner Sanofi-Aventis (NYSE:SNY), will be followed-up for safety, International Prostate Symptom Score (IPSS) and quality of life during the extended treatment, providing follow-up data on cetrorelix for up to 5 years.
Insmed (NASDAQ:INSM): On 5/13/09, INSM reported its quarterly operating results, including an update on the clinical development of IPLEX, for which the Company continues to expect preliminary Phase 2 results in the treatment of Myotonic Muscular Dystrophy (MMD) during 2Q09. The FDA will also allow Insmed to provide access to IPLEX for investigational use in patients with Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's disease), and the Company will conduct a controlled clinical trial under an Investigational New Drug (IND) application after finalizing the study protocol with the FDA.
Jazz Pharma (NASDAQ:JAZZ): On 6/15/09, JAZZ announced that sodium oxybate (JZP-6) demonstrated statistically significant and clinically meaningful improvement in pain and the core symptoms associated with fibromyalgia, according to Phase 3 data presented last week. JAZZ has also completed its second Phase 3 clinical trial of JZP-6 and expects to announce top-line results from this study around mid-2009.