In the world of biotechnology and pharmaceuticals, stocks can skyrocket or plunge at the drop of a hat. Late-stage drug trials, FDA approvals, and complicated licensing deals can muddle the waters so much that it often becomes difficult for investors to keep track of what's actually going on. So today we'll cover three companies that, in the past few months or so, have made a splash in the market, and because they all have drugs pending approval, deserve to be on your radar screen.

Orphan status
Neuroblastoma is a cancer that affects the nervous system of mostly small children and infants. Keryx Biopharmaceuticals (Nasdaq: KERX) announced two weeks ago that its experimental drug, perifosine, received orphan drug status from the Food and Drug Administration for that indication. Orphan status is usually granted to drugs targeting diseases that affect fewer than 200,000 people; companies that research and develop these drugs can receive special incentives and marketing exclusivity if they are successful. If the drug proves viable, it will compete with Cytoxan, a generic drug manufactured by Bristol-Myers Squibb (NYSE: BMY). Right now, perifosine is in phase 3 trials for treating colorectal cancer and myeloma. Since the news was announced, Keryx's stock price jumped about 15%, but has drifted back down slightly.

Can't sleep?
If you're having trouble sleeping, you're certainly not the only one. It's estimated that 70 million American adults suffer from some form of insomnia. One study has shown that out of that population, only about 20% are being treated with medication, making this a potentially lucrative segment for the company that can develop the most superior drug. Two of the most popular drugs out there are probably Ambien, which is made by sanofi-aventis (NYSE: SNY), and Lunesta, marketed by Sepracor. However, small-cap Somaxon Pharmaceuticals (Nasdaq: SOMX) just came out with its own grand announcement. In late March, the company said that the FDA had officially approved its drug application for Silenor, which treats insomnia. CEO Richard Pascoe has said, "We believe that Silenor's ability to treat sleep maintenance insomnia into the final hours of the night without meaningful next-day residual effects and without abuse potential uniquely positions Silenor for commercial success." Only time will tell how successful they are, but so far the market hasn't been kind -- Somaxon has dropped almost 60% since the announcement.

Lupus update
Immunomedics (Nasdaq: IMMU) is a research-and-development company that has potential treatments for cancer, autoimmune disorders, and other diseases in various stages of clinical development. In late June, it released further phase 2 data that showed its drug candidate for lupus, epratuzumab, saw meaningful and statistically significant results that illustrated improvements in disease activity. Also in late June, Human Genome Sciences (Nasdaq: HGSI) announced it was submitting its lupus drug, Benlysta, to the FDA for approval, so Immunomedics has some catching up to do.

The foolish bottom line
Each of the three companies listed above reports earnings by early to mid-August. When they do, they should give more detail of any progress on their programs or, in the case of Somaxon, launch. Right now, the next events for these are beginning phase 3 studies for Immunomedics and moving into phase 2 studies as well as phase 3 results for Keryx's perifosine. And, of course, launching Silenor. Hopefully by the time quarterly results are presented, we'll have more information to add to their previous announcements.

It's not easy keeping track of all the drugs coming in and out of the development pipeline, but if you can stay up to date, you often have an advantage -- one that could help you find the next big stock. So check back near the end of August to see if these companies are just treading water or if they're still worth being on your radar screen!