(RTTNews) - The biotechnology sector is a risky investment arena, but investing in such stocks can also be highly rewarding and exciting. A few biotech stocks - DNDN, TRGT,HGSI:
News , VNDA and PLX - covered by our site have returned triple-digit percentage gains to date.
Let's take a look at the upcoming catalysts of the above-mentioned stocks, which have endured wild swings.
Dendreon Corp. (DNDN:
News ) has been a regular topic at RTTNews.com. The stock was trading around $6 when it was featured on our site in
2007 and around $5 in
2008 . The stock now trades around $28.
Dendreon is a classic example of a company with a steely determination to bring its drug to market, despite hurdles and challenges. Following its success in a pivotal late-stage study of Provenge dubbed IMPACT in April of this year, the company filed its amended application with the FDA seeking approval of Provenge on November 2, ahead of its schedule of mid-November.
Provenge, an investigational vaccine for the treatment of prostate cancer, works by stimulating the immune system to recognize a protein known as the prostatic acid phosphatase or PAP, which is found in about 95% of all prostate cancer cells and mounts an attack on the cancer cells.
This is Provenge's second go-around with the FDA. Dendreon filed for approval of Provenge in 2007 and an FDA Advisory Committee voted 17-0 in favor of the prostate cancer vaccine's safety and 13-4 that it demonstrated "substantial efficacy." That the FDA did not approve Provenge despite the advisory panel's favorable votes and requested more data is now part of the Dendreon story.
With the company now having successfully re-filed its application for Provenge, the FDA is expected to announce its decision on May 1, 2010. Assuming Provenge is launched by mid-2010, the company expects the vaccine to be manufactured at its New Jersey facility to garner sales of $60 million to $125 million in the first six months after launch. The New Jersey facility will initially operate at 25% capacity and is anticipated to reach its full capacity in the first half of 2011. When the new manufacturing plants in Atlanta and Los Angeles reach their full production capacity by the end of 2011, the potential annual sales of Provenge are estimated to be $1.2 billion to $2.5 billion.
When biopharmaceutical company
Targacept Inc. (TRGT:
News ) reported positive top-line results from a mid-stage study of its investigational drug TC-5214 as an add-on therapy with citalopram for major depressive disorder on
July 15 , little did anyone realize that the stock would have a rapid rise from $3 to where it is now - over $23.
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