New Drug Approvals - A Date With Destiny...

5/11/2009 3:14 AM ET

(RTTNews) - The biotechnology sector is a risky investment arena and investing in such companies requires a great deal of patience. Drug companies take years -- even decades and burn a tremendous amount of cash to bring a drug to the market.

Some drugs pass the FDA muster easily, while some struggle through the arcane process of regulatory approval. For a one-trick pony company, which does not have a safety net for failure of the lead compound, the FDA decision can seal the fate of the company.

However, despite the regulatory setbacks, some companies exude a steely determination to bring their drugs to market and their patience has been amply rewarded. Some of the recent classic examples are Dendreon Corp. (DNDN) and Vanda Pharmaceuticals Inc. (VNDA).

Two years after Dendreon's prostate cancer vaccine Provenge was rejected by the FDA, the drug has got a second chance now. Dendreon plans to refile for FDA approval in the fourth-quarter of this year. The stock, which hit a 52-week low of $2.55 on March 9, 2009, now trades around $19.

Vanda is yet other example of patience and an iron resolve. After initially being rebuffed by the FDA last year, Vanda's schizophrenia drug Fanapt (Iloperidone) made it across the finish line by winning the regulatory approval on May 6, 2009. The stock, which hit an all-time low of $0.45 on December 23, 2008, now trades around $9.

The following are the companies, which are expected to hear the FDA's decision on their drugs during this month.

Hemispherx Biopharma Inc. (HEB: News ), which is awaiting FDA approval of its experimental drug Ampligen for chronic fatigue syndrome, set a new 52-week high of $1.50 on Friday. The FDA decision is due on May 25.

Over the past one-week alone, Hemispherx gained a whopping 160%. The current run up in stock price of Hemispherx can be attributed to the prospects of flu profits. The risk of a swine flu pandemic has boosted the share prices of anti-viral drug companies and Hemispherx is one among them.

Ampligen, which has earned the sobriquet, "a drug in search of a disease", is also in preclinical testing for avian flu in the U.S., Japan and Canada. On April 27, it was announced that the Japanese government is accelerating the Ampligen research program in human volunteers. The recent emergence of a new swine flu strain with high associated mortality in Mexico provides additional significance to the Japanese studies.

Hemispherx's collaborative partner in Japan, Biken Corporation has also successfully completed a series of animal/preclinical tests on Ampligen as an enhancer for seasonal influenza vaccine.