Below are extreme trades among 18 companies with stock prices under $5 from the
BioMedReports.com FDA Calendar, which includes 232 entries as of 7/3/09. 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 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 clinical trial results.
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. Another approach is to buy a basket of stocks well ahead of their expected binary events before the trading crowd arrives and causes an increase in the share price and trading volume. As with previous installments, this article is neither an endorsement of the companies profiled nor a complete list of extreme trades included in the FDA Calendar at BioMedReports.
Javelin Pharma (AMEX:JAV) ($1.22): Ereska is a non-opiate pain drug being developed by JAV for the acute treatment of moderate to severe pain in military, trauma, post-operative, and emergency room settings with the potential for treating breakthrough pain from cancer as well. The drug is delivered by a disposable manual pump with a rapid onset and duration of pain relief of about two hours without opiate side effects such as respiratory depression. JAV expects to release the primary endpoint data from the Ereska (intranasal ketamine) Phase 3 pivotal trial in mid-2009, which consists of 220 adult patients to evaluate the safety and effectiveness of the drug in the treatment of acute pain (arising from surgery, trauma, or injury). A NDA filing for Ereska is possible by late 2009. On 6/23/09, JAV reported that it successfully completed a safety study of Dyloject in the U.S. and plans to submit a NDA for FDA approval in the fall of 2009.
On 3/9/09, Acrux (ASX:ACR) (ARUXF.PK) ($1.03) announced that its Testosterone MD-Lotion development program achieves key milestone and will be commercialized as Axiron. Achieved enrollment of 150 men in a pivotal Phase 3 open-label trial as planned with trial results expected 3Q09 and a FDA submission anticipated by the Compnay during December 2009.
In late March, Arena Pharma (NASDAQ:ARNA) ($4.85) announced top-line results from its BLOOM clinical trial of experimental weight loss drug lorcaserin, and the Company expects to report results from the second pivotal trial, BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), by the end of September 2009 and expects to submit a NDA for FDA approval by year-end. Vivus (NASDAQ:VVUS) ($5.90) and Orexigen Therapeutics (NASDAQ:OREX) ($5.67) also expect to report pivotal Phase 3 clinical trial results during 3Q09 for their experimental weight loss drugs Qnexa and Contrave, respectively.
On 5/6/09, Cardium (AMEX: CXM) ($1.85) announced the completion of recruitment for the Phase 2b MATRIX clinical trial to evaluate the safety and efficacy of Excellarate for the treatment of non-healing diabetic foot ulcers. The MATRIX Data and Safety Monitoring Board has reviewed safety data collected from study participants as of 4/21/09 and reported that Excellarate appears to be both safe and well tolerated, with no serious adverse events attributable to the study product. The Company expects to report on key efficacy data in September 2009, including the percentage of patients achieving complete wound closure, the rate of wound closure and the reduction of wound size at various time points.
Cardium also continues to build and enhance its InnerCool Therapies operating unit with a specific focus on the development of a new class of targeted organ-specific cooling applications, including its UroCool pelvic cooling catheter system, which is designed to induce localized cooling during surgery for prostate cancer. An application for FDA 510(k) clearance of the UroCool pelvic cooling catheter system was submitted during 1Q09.
On 5/7/09, Biodel (NASDAQ:BIOD) ($4.69) updated its plans to submit a new drug application (NDA) to the FDA during 2H09 for approval to market VIAject for the treatment of diabetes. The NDA will be based upon results from multiple pharmacokinetic and pharmacodynamic studies, studies of VIAject in patients with Type 1 and Type 2 diabetes on post-prandial glycemic control compared to regular human insulin and the rapid-acting analog, Humalog, as well as the two completed Phase 3 studies of VIAject in patients with Type 1 and Type 2 diabetes. Biodel is now preparing its NDA submission and initiating studies designed to further differentiate the therapeutic potential of VIAject from existing rapid-acting prandial insulins.
On 5/7/09, Avanir Pharma (NASDAQ:AVNR) ($2.15) provided an update on its lead, Phase 3 compound called Zenvia (dextromethorphan + quinidine). AVNR completed target enrollment on 3/16/09 of patients into the STAR trial, which is a confirmatory Phase 3 clinical trial of Zenvia in patients exhibiting signs and symptoms of pseudobulbar affect. The randomized, multi-center, international STAR trial is designed to compare the effects of Zenvia 30/10 mg, Zenvia 20/10 mg and placebo on the rates of involuntary crying and laughing episodes. The final number of patients exceeded the original target by approximately 20% allowing a larger safety database and increased statistical power for the study.
