Since I've received so many positive reader emails about my first and second installments on biotech investing, I've put together a third list of biotech companies that have major catalysts (clinical trial data and FDA decisions) coming up. These companies are expected to be on the move within the next nine months and have a market cap ranging from around $100 million to just beyond $1 billion.
On April 18, Cortex (AMEX: COR) submitted a data package to the FDA providing convincing evidence that the specific brain tissue specimen changes seen in animal toxicology studies -- which previously caused the FDA to put CX-717 on clinical hold -- are a postmortem fixation artifact unrelated to the drug, and are not found in the tissue of the animal while it is still alive. The FDA partially lifted the clinical hold on CX-717 last fall, but dosing restrictions in this ruling prevent Cortex from pursuing further studies for the lucrative ADHD indication. The FDA should respond to Cortex by mid-June, and will probably lift the current high-dose restriction imposed on CX-717. If the company gets this crucial endorsement from the FDA, the stock should quickly move back above its previous $5 per share. For more information on this story, check out my article "Consider Cortex."
In March, Savient
(NASDAQ:SVNT)announced that it had reached its phase 3 enrollment target of 200 patients in two placebo-controlled six-month clinical trials. These trials were designed to assess the safety and effectiveness of Puricase in treatment-failure gout, under a Special Protocol Assessment from the FDA. Completion of the in-life portion of the phase 3 trials is expected during the fourth quarter of this year, with release of top-line results by year end. So far, Puricase appears to have an excellent chance at achieving all of its safety and efficacy endpoints in the ongoing study.
(NASDAQ:EICU)shareholders are anxiously awaiting the results of a second re-examination recently filed in the U.S. Patent and Trademark Office (USPTO) by iMDsoft, a software company that develops clinical information systems. This pending case covers all of the claims of VISICU's contested patent, which received a successful initial re-examination by the USPTO last year. As I wrote in this article, I believe that VISICU will receive a positive decision in this case, which should provide upside to the shares from current levels, but the exact timing of any decision is difficult to predict.
(NASDAQ:VVUS)is set to receive an up-front $10 million for a recently announced deal with KV Pharma (NYSE:KV-A), an additional $140 million upon approval of the New Drug Application for EvaMist, and payments of up to $30 million based on sales milestones. The NDA is currently under review by the FDA, with a positive decision for the estrogen replacement therapy spray likely to come by July 29. Also watch out for future plans for the company's experimental weight loss drug Qnexa, which has demonstrated promising results in previously announced studies.
Keep in mind that this story is not meant to serve as an exhaustive list of all companies in the sector. I purposely excluded the biggest and best-known biotech and big pharma companies. Once again, my goal is to provide readers with a selection of companies that offer good leverage as a result of their smaller size, and have a major shakeup in the works. We should see some interesting developments from these companies in the weeks and months to come.
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Fool contributor Mike Havrilla, R.Ph., B.S., Pharm.D., is a Rite Aid pharmacist who lives and works in the small Pennsylvania town of Portage. He invites your comments and feedback. Mike does not have a position in any company mentioned in this article. The Fool has a disclosure policy.