62% Gain for Adventrx in One Day. More to Come? Print E-mail
By M.E.Garza   
Monday, 28 December 2009 21:06

technical analysisSubscribers were alerted to this stock's breakout chart on December 16th when chares were selling for $.13 and it has traded up like clockwork ever since.

On Monday, Adventrx Pharmaceuticals Inc. (AMEX: ANX) gained 62.38% and closed at $.34. The price is still undervalued given the value proposition that Adventrx presents its shareholders and the $1.20 median price target from Thomson Reuters. Note also that SEC filings show that insiders, mutual funds, institutions and billionaire Carl Icahn all own millions of shares of this "penny stock."

Now we're telling our readers the same thing told them the morning following our first alert: "The stock is expected to go higher in the coming days." It may even see $.50 during Tuesday's trading, given the type of activity we observed after hours on Monday the 28th.

ADVENTRX is a biopharmaceutical company whose product candidates are designed to improve the safety of existing cancer treatments. They recently announced that they intend to submit an NDA for ANX-530 (vinorelbine emulsion) by the end of 2009, having successfully completed the final activities required for that NDA submission. Market makers, who had been naked shorting the stock, are now scrambling to cover.

ANX-530 is a novel emulsion formulation of the chemotherapy drug vinorelbine. Navelbine, a branded formulation of vinorelbine, is approved in the U.S. to treat advanced non-small cell lung cancer. The ANX-530 formulation emulsifies vinorelbine into a homogeneous suspension of nanoparticles that may reduce exposure of the venous endothelium during administration of the drug. Worldwide sales of Navelbine and its generic equivalents in 2006 were in excess of $200 million.

ADVENTRX also announced that a recently completed preclinical study has affirmed the bioequivalence and comparable toxicity of ANX-514 and Taxotere® (docetaxel). Shin Poong Pharmaceuticals, ADVENTRX's partner for ANX-514 in South Korea, independently conducted the study and data analysis.

For each ANX-530 and ANX-514, the company views these bioequivalence trials as registrational clinical studies in that they have the potential to support a marketing application. If approved, the drug prescribing information, or "label," for our products may reflect clinical data generated during the bioequivalence trials, including comparative adverse event information.

The Company plans to file an NDA for both of these drugs based on the provisions of section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act.

Section 505(b)(2) allows the FDA to approve a drug on the basis of data in the scientific literature or data previously cited by the FDA as the basis for the approval of related drugs. This procedure makes it easier and potentially faster for drug developers to obtain approval of new formulations of drugs based, in part, on proprietary data of the developer of the original drug. The relatively low number of required patients and the single-dose treatment cycles associated with these bioequivalence trials decreases study timelines and costs relative to typical pivotal studies. Accordingly, with relatively modest financial investment, the company was able to assess the pharmacokinetic equivalence of each of their product candidates to the reference product in as little as 12 to 18 months, which information should provide the clinical data necessary to support the NDA.

By securing in advance FDA agreement regarding their planned regulatory pathway, as they have done for ANX-530 and ANX-514, they mitigate aspects of the clinical and regulatory risk associated with drug development. Furthermore, if and after they obtain marketing approval, they can conduct additional clinical studies while marketing those products for use in new indications or to expand product labels in ways that might increase their commercial value.

Here is a look at the latest daily chart:

Disclosure: Long ANX

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