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ANX - Sector: Healthcare---Industry: Biotechnology & Drugs

Started by saffeysite1, May 09, 2005, 06:45:47 PM

Previous topic - Next topic

saffeysite1

$3.50 at close.  Sleep tight everyone and see ya on Monday.

setravis


3SOF......SOLD This moments ago!!!!!
I'm selling also.I will follow 3SOF on this sell.
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

Ramsburg

Quote from: setravis on September 07, 2005, 01:46:24 PM

3SOF......SOLD This moments ago!!!!!
I'm selling also.I will follow 3SOF on this sell.

Hi Setravis,

I really enjoy ANX... And I believe it will be a mid-term winner, but I had to follow my plan, and sold to the 3 stocks portfolio @ 3.80 ;)

regards,
Frederick Ramsburg
www.3stocksonfire.org

Try our Premium Service or just Register a FREE Account

mexirafa

Hello,

Perhaps a good one to keep it on the radar ;)

rafael
" It is  always profitable to study our own mistakes"

setravis

(ANX)........
ANNOUNCES POSITIVE RESULTS FROM CLINICAL STUDY: ADVENTRX Pharmaceuticals,
Inc. (ANX) announced positive results from its marketing-enabling clinical study of ANX-530
(vinorelbine emulsion). Pharmacokinetic equivalence, the primary endpoint of the study, was
observed between ANX-530 and Navelbine(R), the reference product, in patients with advanced
cancer potentially sensitive to vinorelbine. The Company anticipates safety and full clinical results
will be available during the first quarter of 2008. ANX-530 is a novel emulsion formulation
of vinorelbine. Vinorelbine, marketed under the brand name Navelbine(R), also available as
generic vinorelbine, is an anti-cancer agent approved to treat advanced non-small cell lung cancer
as a single agent or in combination with cisplatin. Worldwide annual sales of Navelbine and
generic vinorelbine in 2006 were approximately $200 million.
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

SAN DIEGO, Feb 10, 2009 /PRNewswire-FirstCall via COMTEX/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Alternext US: ANX) announced today that it has received written indications of interest from numerous companies representing a range of strategic transactions. The Company currently is evaluating all proposals and options. In December 2008, the Company announced that it was exploring a range of strategic options, including the sale or disposition of one or more of its product candidate programs, a strategic business merger and other transactions that maximize the value of the Company's assets.

"We are pleased with the number and breadth of opportunities presented to us and are currently negotiating with interested parties," stated Brian M. Culley, Chief Business Officer of ADVENTRX. "In order to provide sufficient flexibility to consummate a transaction on appropriate terms, we continue to curtail our spending. While this may impact the timelines of our regulatory filings, it is likely that a future partner would make the final decision on the timing of each NDA submission. However, we still remain on track to announce pharmacokinetic data from our bioequivalence study of ANX-514 in the second quarter."

About ANX-514 (docetaxel emulsion)

ANX-514 is a novel nano-emulsion formulation of the chemotherapy drug docetaxel, a formulation of which is marketed under the brand name Taxotere(R). ANX-514 is formulated without polysorbate 80 or other detergents and is intended to reduce the severity and incidence of hypersensitivity reactions. Docetaxel is an anti-cancer agent that acts by disrupting the cellular microtubular network that is essential for cell division. Immunosuppressant premedication is recommended for docetaxel therapy to reduce the incidence and severity of hypersensitivity reactions. Docetaxel is approved to treat breast, non-small cell lung, prostate, gastric and head and neck cancers.

About ANX-530 (vinorelbine emulsion)

ANX-530 is a novel emulsion formulation of the chemotherapy drug vinorelbine. ANX-530 emulsifies vinorelbine into a homogeneous suspension of nanoparticles that is designed to protect the venous endothelium during administration into a peripheral vein. Navelbine(R), a branded formulation of vinorelbine, is approved in the U.S. to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin, and approved in the European Union to treat non-small cell lung cancer and advanced or metastatic breast cancer.

About ADVENTRX Pharmaceuticals

ADVENTRX Pharmaceuticals is a biopharmaceutical company focused on in- licensing, developing and commercializing proprietary product candidates primarily for the treatment of cancer. The Company seeks to improve the performance and commercial potential of existing treatments by addressing problems associated with these treatment regimens. In December 2008, the Company announced that it is exploring a range of strategic options, including the sale or disposition of one or more of its product candidate programs, a strategic business merger and other transactions that maximize the value of the Company's assets. More information can be found on ADVENTRX's web site at http://www.adventrx.com.

Forward Looking Statements

ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that involve risks and assumptions that, if they materialize or do not prove to be accurate, could cause ADVENTRX's results to differ materially from historical results or those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that ADVENTRX will be unable to consummate a strategic or partnering transaction or raise sufficient capital to fund the projects necessary to meet its goals, including funding the continued development and commercialization of ANX-530 or ANX-514; the risk that the Company's recent cost-containment measures, as well as any future workforce reductions and/or reductions/delays in spending, will further impact the Company's development and commercialization plans, including its ability to achieve on time its previously stated goals; the risk that the departure of the Company's former Chief Executive Officer and President and Executive Vice President and Chief Financial Officer and/or ADVENTRX's leadership by a committee of executive officers will negatively impact ADVENTRX's ability to execute its business plan or to maintain effective disclosure controls and procedures or internal control over financial reporting; the risk the FDA will determine that ANX-530 and Navelbine are not bioequivalent, including as a result of performing pharmacokinetic equivalence analysis based a patient population other than the population on which ADVENTRX based its analysis; the risk that the bioequivalence study of ANX-514 does not demonstrate pharmacokinetic equivalence or bioequivalence to Taxotere; the risk of investigator bias in reporting adverse events as a result of the open-label nature of the ANX-530 bioequivalence study, including bias that increased the reporting of adverse events associated with Navelbine and/or that decreased the reporting of adverse events associated with ANX-530; difficulties or delays in manufacturing, obtaining regulatory approval for and marketing ANX-530 and ANX- 514, including validating commercial manufacturers and suppliers and the potential for automatic injunctions regarding FDA approval of ANX-514; the potential for regulatory authorities to require additional preclinical work or other clinical requirements to support regulatory filings, including prior to the submission or the approval of an NDA for ANX-530 and ANX-514; the risk that the performance of third parties on whom ADVENTRX relies to conduct its studies or evaluate the data, including clinical investigators, expert data monitoring committees, contract laboratories and contract research organizations, may be substandard, or they may fail to perform as expected; the risk that ADVENTRX's stockholders will not approve a strategic or capital-raising transaction recommended by ADVENTRX's Board of Directors; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at http://www.sec.gov.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date on which it was made.

SOURCE ADVENTRX Pharmaceuticals, Inc.



http://www.adventrx.com/ 

Copyright (C) 2009 PR Newswire. All rights reserved




"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

market pulse
Jan. 6, 2011, 11:11 a.m. EST

Adventrx climbs on FDA update

BOSTON (MarketWatch) -- Shares of Adventrx Pharmaceuticals /quotes/comstock/14*!anx/quotes/nls/anx (ANX 2.96, +0.03, +1.02%) advanced in early trading Thursday on news that the U.S. Food and Drug Administration has accepted the market application for its drug Exelbine, or vinorelbine injectable emulsion. The product is an new formulation of the chemotherapy agent vinorelbine, also known as Navelbine, which is used for the treatment of lung cancer. Adventrx shares were up 14% at $3.04.

Below the 3 year chart...

Day's Range: 2.92 - 3.45
52wk Range: 1.50 - 13.00
Volume: 6,371,770
Avg Vol (3m): 447,753
Market Cap: 43.07M
P/E (ttm): N/A
EPS (ttm): -1.65
Div & Yield: N/A (N/A)

Technicals
Close Above the 13-day EMA
Most Actives
Gap Up
Percentage Gainer

Last Price Quote is:
9.16%above 13-day EMA
21.21%above 50-day EMA
RS Rating: 89 
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

FDA Accepts Exelbine NDA for Filing

Press Release Source: ADVENTRX Pharmaceuticals, Inc. On Thursday January 6, 2011, 8:00 am EST
SAN DIEGO, Jan. 6, 2011 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for its product candidate ANX-530 (vinorelbine injectable emulsion), or Exelbine. The filing of the Exelbine NDA means the FDA has made a threshold determination that it is sufficiently complete to permit a substantive review. 

"We are pleased to have reached this important milestone, and look forward to working with the FDA on moving Exelbine toward approval in 2011," said Brian M. Culley, Chief Executive Officer of ADVENTRX.

About Exelbine

ADVENTRX is seeking approval of Exelbine for the same indications as Navelbine®, a branded formulation of vinorelbine, including non-small cell lung cancer.  ADVENTRX submitted the NDA as a 505(b)(2) application that relies in part on the FDA's findings of safety and effectiveness of a reference drug.  The Exelbine NDA includes data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of Exelbine and Navelbine, the reference drug.  In this clinical bioequivalence study, Exelbine and the reference drug were determined by ADVENTRX to be bioequivalent. 

ADVENTRX retains exclusive worldwide rights to Exelbine, other than in South Korea, China, Hong Kong, Macau and Taiwan.  In March 2010, the FDA conditionally accepted "Exelbine" as the proposed proprietary name for ANX-530.  The United States Patent and Trademark Office has allowed patent claims related to Exelbine, which claims will issue in January 2011 and expire in November 2027. 

About ADVENTRX Pharmaceuticals

ADVENTRX Pharmaceuticals is a specialty pharmaceutical company whose product candidates are being developed to improve the performance of existing anti-cancer drugs by addressing limitations associated principally with their safety and use.  More information can be found on the Company's web site at www.adventrx.com.

Forward Looking Statements

ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that are based on ADVENTRX's current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements regarding regulatory approval of Exelbine based on the 505(b)(2) NDA accepted for filing, working with the FDA in the regulatory review process and the bioequivalence of Exelbine and Navelbine. Actual events or results may differ materially from those expressed or implied by the forward-looking statements in this press release due to a number of risks and uncertainties, including, without limitation: the risk that ADVENTRX does not receive FDA approval of Exelbine on a timely basis, or at all; the potential for the FDA to determine that the bioequivalence data and other information included in the Exelbine NDA does not adequately support bioequivalence with Navelbine, including as a result of performing pharmacokinetic equivalence analyses based on a patient population other than the population on which ADVENTRX based its analysis; the potential that changes made in transferring the manufacturing process for Exelbine may result in a lack of comparability between the commercial product and the material used in the bioequivalence trial; the risk that results of future stability testing on samples of Exelbine do not support comparability between ADVENTRX's prior and intended commercial manufacturing sites or a commercially-viable expiration dating period; the potential for the FDA to impose other requirements to be completed before or after approval of the Exelbine NDA, including that the FDA may require ADVENTRX to perform additional nonclinical, bioequivalence or clinical studies; ADVENTRX's reliance on third parties to assist with its bioequivalence trials, regulatory submissions, manufacturing and other important aspects of the Exelbine development program, and the risk that FDA approval may be delayed if their performance is found to have been substandard; the risk that any patent issued to ADVENTRX may not provide sufficient protection and market exclusivity for Exelbine and may be challenged, invalidated, infringed or circumvented by third parties, including by ADVENTRX's competitors; ADVENTRX's dependence on the success of Exelbine as its first product candidate to be submitted for regulatory approval; the potential that ADVENTRX may require substantial additional funding in order to obtain FDA approval for and commercialize Exelbine, and the risk that ADVENTRX may not be able to raise sufficient capital when needed, or at all; the potential for ADVENTRX to enter into a commercial partnership or other strategic transaction relating to Exelbine and that such partnership or transaction may not succeed in commercializing Exelbine; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at www.sec.gov. 

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date hereof, except as may be required by law.

"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis