Optimer Pharmaceuticals (OPTR) is quickly approaching its May 30 PDUFA as as heavy favourite to win a positive vote from the FDA to market its product, yet it seems that many investors are discounting the potential for a surprise negative outcome. The company is trying to obtain approval for its flagship product, fidaxomicin which could make it the first Clostridium defficile infection (CDI) treatment in more than 25 years. Currently, the infection only has two pharmacological options as treatments: metronidazole and oral vancomycin, both of which lack the ability to reduce recurrences, while improving global cure rates.

While the cure rates on fidaxomicin matched that of vancocin, the company has claimed that its real benefit lies in its ability to reducing the recurrence rate. In the two Phase 3 trials, among subjects who had experienced a prior CDI episode and recurred within three months of entering the study, treatment with

The month of May has thus far been a very profitable one for investors in a number of small cap biotechs leading up to the June 2011 ASCO meeting -- particularly ones that haven’t consequently fared too well once their respective binary events had met its endpoints.

First up on the list is Oxigene, Inc. (OXGN), which has experienced nothing short of a meteoric rise from the $1.5 price per share level to $5.24 in a matter of three weeks following our report discussing the nearing of marketing approval of the first anaplastic thyroid cancer drug. While early technical analysis showed clear evidence of the oversold and undervalued condition, the stock has now begun trading at 10 times average volume in each of the past few days during this run, which often signals that a few hedge funds and institutions have begun to take a controlling stake in its

To many, Atmel (ATML) remains an undiscovered secret within the technology sector, yet recent exclusive semiconductor manufacturing deals with the likes of LG, Nokia (NOK), and Motorola (MMI), have begun to spur interest. This is a company that is well positioned both technically and fundamentally in order to reach new 52-week highs as the company reported last Wednesday that its profit more than quadrupled, with revenue climbed well beyond analyst estimates.

Within the first quarter of 2011, it went on to earn $74.6 million, which translates to 16 cents per share in the first three months of the year. That compares very favorably with $16.6 million, or 4 cents per share, in the year-ago quarter. Analysts polled by FactSet expected 15 cents per share in the latest quarter. Revenue also jumped 32 percent to $461.4 million, while analysts were expecting $453.2 million. Atmel followed that up by announcing a

Medivation (MDVN) was once a thriving biotech with some of the most promising treatments for Alzheimer’s, Huntington Disease and Prostate cancer. Reaching an all-time high of $40 per share back in early 2010, the stock had investors on the edge of their seat in anticipation of what could come, but instead fell short as the Horizon (mild-to-modarate) Alzheimer’s trial failed to improve the cognitive abilities in patients, which was the primary goal of the trial.

This development caused shares to immediately plunge to $12, leading many shareholders to exit their positions and move onto other opportunities. Since then, shares have quietly crept up more than 67% as a new ray of hope has emerged for its Alzheimer’s drug. In light of the bad news, University of Southern California Alzheimer’s expert Lon Schneider sees a positive amidst all the uncertainty. According to Robert Langreth of Forbes, “Schneider points out that

Prostate cancer is the most common form of cancer among men, and two companies - Medivation (MDVN) and Johnson & Johnson (JNJ) - are leading the charge with their experimental new treatments. These two will highlight their findings at The American Society of Clinical Oncology (ASCO), a meeting which has quickly become one of the most important events of the year.

From an investment standpoint, the momentum in cancer drug stocks has emerged well ahead of the May 18th deadline as investors pile on the bets over who will reign supreme. The new drugs in focus are Medivation’s MDV-3100, and Johnson and Johnson’s abiraterone, both of which are set to present critical phase III data results at any time prior to or during the meeting.

Of the two, the highest potential and most promising data from early to mid-stage trials belongs to Medivation, as the company is on the verge

In February, Clinical Data (CLDA) won a surprising approval for its flagship product, viibryd, the first antidepressant approved by the FDA in over 15 years, leading to Forest Labs (FRX) sweeping in to buy the company for $1.2 billion. Forest’s price reflects its interest in viibryd’s claim that it is safer and triggers fewer sexual side effects than other SSRI drugs now on the market. The drug is being touted as the “first and only” antidepressant to combine an SSRI and a serotonin 1a receptor partial agonist in one molecule.

This left many biotech bargain hunters looking for the next blockbuster buyout, which may lead to Optimer Pharmaceuticals (OPTR). Much like Clinical Data’s recently approved viibryd, Optimer’s flagship product, fidaxomicin, has a higher safety profile, along with many other added benefits which could make it the first Clostridium defficile infection (CDI) treatment in more than 25 years.

Currently, the

San Diego-based Optimer Pharmaceuticals (OPTR) has spent more than $200 million and a dozen years of effort to get to the point where it can ask the FDA to clear its first product for sale on the U.S. market. The company has received little praise from the biotech crowds that usually scour the industry for hidden gems, yet this may soon change as it nears its 4/5/11 meeting with the FDA advisory panel which many experts agree will be highly positive, due to its efficacy. The flagship product, Fidaxomicin, which has IP protection until 2026, is tapping into a $7B industry which has increased significantly in recent years in both North America and Europe, with little-to-no competition.

Unlike many biotech companies, Optimer maintains a healthy balance sheet, which has roughly $192M cash on hand, no major debt financing, and it recently signed a $224M deal for partnership in Europe.

The following is a comparison of Apricus Bio (APRI), which is awaiting FDA approval for a Special Protocol Assessment (SPA) on ProvOnco (liver cancer) during 1st quarter 2011 and Threshold Pharma (THLD), which received this designation for TH-302 (soft tissue sarcoma) in the pre-market of Wednesday’s trading session.

Few and far between from the investment community had been aware of Threshold, a small company based out of California whose shares rose 80% at one point, before cooling off to 57.14% higher on nearly 16 times average volume. The interest was sparked by their product, TH-302, a novel treatment for soft tissue sarcoma, which received a SPA for their Phase 3 randomized trial. “With this SPA, we have reached agreement with the FDA on the key features of our Phase 3 trial design that will be necessary to support the registration of TH-302,” said Stewart Kroll, Threshold’s vice

Flying under the radar from many retail and institutional investors and into the new year comes Apricus Bio (APRI), a company whose mere 50M market cap is substantially undervalued based on its large diverse product portfolio, healthy financial standing, and forward looking market possibilities.

The company and its two wholly owned subsidiaries, NexMed and Bio-Quant, owns a total of 12 diverse products and compounds in development from pre-clinical through phase III that are focused on dermatology, sexual dysfunction, diabetes and cancer. With several key upcoming events, of the likes including Vitaros (erectile dysfunction) NDA application during 1st quarter 2011, for Middle East market and European market expected 2nd quarter 2011 with Middle East in the 1st quarter, ProvOnco (liver cancer) whose awaiting special protocol assessment reply by FDA during 1st quarter 2011, and Femprox (female sexual arousal disorder), it seems clear that a breakout in share price with

AdventRx Pharmaceuticals (ANX) is a company that is rarely mentioned among the bigger players, though this may soon change as it gains attention heading into its 2011 product pipeline catalysts. As it begins the new year, the stock seems poised to make new 52-week highs as it announced the much anticipated positive 12-month results for ANX-530, was awarded a $500,000 grant, and marketed itself at numerous healthcare & pharma conferences. These events quickly took the share price from $2 to $3 in a matter of weeks, before suddenly dropping back to even par on the eve of financing news leaving potential investors hungry for the new year.

Currently sitting at a market cap of only $32.5M, the potential to grow exponentially is beginning to make waves among expert biotech investors. The flagship product, ANX-530 or Exelbine, for the treatment of non-small cell lung cancer, is a novel emulsion formulation of

Small cap biotech investments with upcoming FDA catalysts have become one of the hottest new trends, especially due to the fact that it is easy to foresee or expect catalysts based on the use of FDA calendars and general medical timelines on drug and clinical trials. Unlike other industries where new technologies in research and development are usually kept secret in order to deter competition, the biotech game is wide open as companies publicize their products from the very beginning all the way to marketing approval. This is because biotechs usually need on average $50-75 million dollars from an investigational new drug status all the way to completing phase I, II, and III trials and then into marketing. They thus look to maximize their market caps earlier on based on hype in order to fund projects through share offerings.

While many investors have become wealthy from multi-bagger gains by holding

The stem cell market is slated to become $88.3 billion by 2014, with growth of well over 14.8% from now until then. This paves the way for potential revenues that border the imagination for any Wall Street analyst should any company become the first to see FDA approval. While at first thought this may sound like a juicy opportunity to jump on, unfortunately the best results companies have come up with are approvals for clinical phase I, II, and III trials and a few new drug applications here and there followed by rejections. A little disheartening, perhaps, but there is one company, Osiris (NASDAQ:OSIR), whose product Prochymal has slowly but surely begun to make waves among the investment community as it races to become the first approved and marketed stem cell product. By far, the best way to describe this undervalued, hidden company is — finding opportunity amongst uncertainty.

Osiris

Ever since the New York Stock Exchange building opened on April 22, 1903, it has flawlessly followed a particular pattern that, even to this day, still stands: hope, greed, skepticism, followed by, fear, panic and despondency, whereby the pattern is once again repeated, going back to hope. It is a cycle that can either make or break traders, whether expert or beginners, as the ability to distinguish between the greed and skepticism aspects is usually overshadowed by money. As the infamous 1987 Wall Sreet movie character, Gordon Gekko once said, “It’s a zero sum game, somebody wins, somebody loses. Money itself isn’t lost or made, it’s simply transferred from one perception to another.” Taking this into account, its now important to identify how the markets have begun to step into the skepticism state of mind, with fear beginning to quietly tip toe through the herd of retail investors.

One of

In a day and age where uncertainty seems to rule the culture of the stock market world, call and put options have become increasingly popular in order to hedge a portfolio from a potential unforeseen event. Unfortunately, this is how most investors view options; however, many forget that it could also be used as a tool to guide investor sentiment within the near future. In simple layman’s terms — more often than not, a company bound to have positive developments will see a high increase in call options traded, and vice versa with put options should negative outcomes be expected.

At the forefront of the biotech market lie two companies - Clinical Data (NASDAQ:CLDA) and BioSante (NASDAQ:BPAX) - that could potentially see themselves as having a new breath of life. Both companies are due to have very important FDA catalysts that could revolutionize their respective markets, and it seems like

Within the $14 trillion US market, the biotechnology sector has become a hot investment option for those looking to hedge against a possible upcoming market correction. During the past six months, shares within the NASDAQ Bio Index (NASDAQ:IBB) are up 20.12%, while the S&P Bio Index (NYSE:XBI) matched those gains with 21.02%. This is not especially surprising when considering that the companies in this industry are guided primarily by the science behind the products rather than the economic environments surrounding them.

Many small pharmaceutical companies experience large percentage gains leading up to their new drug application (NDA) or potentially positive results from ongoing clinical trial results that may attract partnerships, buyouts and other attractive events for shareholders. No better company exemplifies these opportunities than Neoprobe Corporation (NEOP.OB), whose 2011 upcoming events may propel it to new 52-week highs in the blink of an eye. Here is a 20-year old biotech

Following the Christmas break, shares of BioSante (NASDAQ:BPAX) soared more than 27% during Monday’s session on volume of 10.57M shares versus an average of 251,478, leaving investors hungry for the company’s potential that should be enhanced thanks to upcoming FDA catalysts in early 2011, as highlighted by our previous article. All seemed well going into the next trading session, until the after-hours session when news of a registered direct offering sparked newly found worries striking fear in the hearts of current and potential shareholders.

To those who follow the biotech industry religiously, this occurrence shouldn’t catch anyone off guard, and in most cases does not pose a major roadblock for an undervalued company whose investment purposes should be for the long-haul rather than flipping a few pennies on the dollar. As an immediate example, during the month of December, no less than three highly profiled biotech companies with

The biotech universe has been a hot investment option towards the end of the year for those looking for high risk high reward equities. This industry offers investors a chance to find companies where price per share is valuated based on science rather than heavy influence from major indices and economic news around the world. Though often times it is hard to distinguish the golden eggs among the rotten ones, it is becoming increasingly popular to see investors and firms begin buying up companies prior to their upcoming FDA catalysts in anticipation of the news, often a few weeks or months in advance.

One of the companies looking to take advantage of the recent inflow of attention to the small cap biotechs is BioSante Pharmaceuticals (NASDAQ:BPAX), who has 2 upcoming catalysts for the first half of 2011 which could easily propel the company to new 52-week highs. It

Being a contrarian and playing a heavily shorted stock can, in some situations, lead to a ” short squeeze” and thus be one of the most profitable ways to make money in the markets. A “short squeeze” occurs when short-sellers rush to cover their positions due to a rapid increase in the price of a stock or futures contract. Such an event generally occurs in stocks that have small floats and a large number of short positions (relative to the float).

A “short squeeze” can be caused by any number of different reasons – generally speaking, the most common cause is an unexpected piece of good news for a company. This leads to people taking new positions in the company’s stock, the price rising and short-sellers deciding that they want to get out of the stock. The short-covering only adds fuel to the fire, sending the shares even higher.

Both

Clinical Data (NASDAQ:CLDA), a once small and unnoticed biotechnology company, has now turned into the talk of the town, having everyone awaiting anxiously for its blockbuster drug, Vilazodone, to receive word from the FDA on approval during the set January, 22, 2011 action date.

With game-changing potential to completely revolutionize the annual $12 billion dollar antidepressant market, it seems investors are finally starting to take notice of Clinical Data. In preparation for their marketing approval, the company went ahead and sold a pharmacogenomics biomarker development business for $15.4 million on November, 20, 2010, thus allowing for a healthy balance sheet and negating any fears of potential dilution prior to approval.

Well known Wall Street columnist, Gene Marical, recently shed light on the chatter going around, stating,

Some analysts say Vilazodone has made Clinical Data an attractive takeover target for any of the major players in the field, including