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#311
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Junior Trader
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Advanced Life Sciences [[ADLS]] Cethromycin NDA (once-daily antibiotic for the treatment of community acquired pneumonia - CAP) is pending with an expected PDUFA decision date of 7/31/09. On 6/2/09, ADLS announced that the FDA’s Anti-Infective Drugs Advisory Committee voted in the majority that Restanza (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate CAP (11 positive, 3 negative, 1 abstaining). However, the committee voted that Restanza did not demonstrate efficacy in the treatment of CAP (3 positive, 11 negative, 1 abstaining).
This looks to be the reason for the pullback this morning. |
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Check the ADLS thread and do your DD with this stock. When the news below was released, the stock plummeted from 1.4 to .3 on the same day. It has been going up since as folks hope the FDA will still approve the drug. IMO, I am out of this stock. You may make money on it, but the FDA could just as easily turn down the drug and it will drop again. I think there are other biopharms out there with less risk.
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ANX
Please post WHY this is up today and insert symbol like this: Type: ANX Select text, and press ![]() This saves everyone time on what price, etc. stock is currently at. Further, if you explain WHY the stock is up, we can do further research more efficiently. |
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UberTrader
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Not sure if this stock is in this thread. VICL
I've owned it for a while and I am down about 15%. It is not a stock to expect to soar soon, but it is an interesting stock to watch in the next year, and maybe take a small position in. Here's reuters description of the company: Vical Incorporated, incorporated in 1987, researches and develops biopharmaceutical products based on its deoxyribonucleic acid (DNA) delivery technologies for the prevention and treatment of serious or life-threatening diseases. The Company has three active independent development programs in the areas of infectious disease and cancer. These are a Phase III clinical trial using its Allovectin-7 immunotherapeutic in patients with metastatic melanoma; a Phase II clinical trial using its cytomegalovirus (CMV) DNA vaccine in hematopoietic cell transplant patients, and a Phase I clinical trial using its H5N1 pandemic influenza DNA vaccine formulated with its Vaxfectin adjuvant. The Company has licensing and collaboration arrangements, such as its licensing arrangements with Merck & Co., Inc. (Merck), the sanofi-aventis Group (sanofi-aventis), AnGes, Aqua Health Ltd. of Canada (Aqua Health), an affiliate of Novartis Animal Health, and Merial Limited, a joint venture of Merck and sanofi-aventis and AnGes, among other biopharmaceutical companies. Cytomegalovirus Vaccine During the year ended December 31, 2008, the Company’s CMV program included a DNA-based therapeutic vaccine to prevent viral reactivation and disease after transplant, which is in a Phase II clinical trial and a DNA-based preventive vaccine to prevent infection before and during pregnancy to preclude fetal transmission, which is in preclinical development. Results from the Phase I trial indicated that its CMV vaccine was safe and well tolerated by a majority of subjects, with temporary injection site pain. The vaccine induced antibody and T-cell immune responses at both dose levels and both dosing schedules tested. Based on these results, the Company designed a Phase II CMV clinical trial was designed to evaluate the safety, immunogenicity, and clinical benefit of a CMV immunotherapeutic vaccine in patients undergoing bone marrow transplants. In November 2008, the Company announced that it had completed enrollment of 80 subjects in the Phase II trial. Pandemic Influenza Vaccine In 2008, the Company completed its Phase I pandemic influenza study. Pandemic influenza is virulent human influenza that causes a global outbreak, or pandemic, of serious illness. A pandemic could begin if the H5N1 virus or another avian influenza virus strain changes to a form that can spread easily from person to person. Allovectin-7 Allovectin-7 is a plasmid/lipid complex containing the DNA sequences encoding HLA-B7 and ß2 microglobulin, which together form a major histocompatibility complex (MHC), class I. The Phase III trial is being conducted at more than 100 clinical sites worldwide. The Phase III trial calls for enrollment of approximately 375 patients with metastatic melanoma. Patients may have been previously treated with surgery, adjuvant therapy, and/or biotherapy, but cannot have been previously treated with chemotherapy. The Company competes with sanofi-aventis, Novartis, GlaxoSmithKline plc, MedImmune, Inc., Merck, Pfizer Inc., Medarex Inc. and Wyeth. Here's a recent article about VICL: After Years of Red Ink, Vical Says DNA-Based Vaccines ‘Ready for Prime Time.’ | Xconomy here's an excerpt from the link aboveL "Samant took charge of Vical in late 2000 after a stint as head of Merck’s vaunted vaccine group. He immediately faced numerous challenges. One was perception. Regulators considered Vical’s vaccines a form of gene therapy, a technology largely focused on using healthy genes to cure inherited disorders. Gene therapy companies typically use viruses to deliver genes, and face added regulatory scrutiny. “It took us a long time, three or four years, to get out from under that gene therapy label,” Samant said. Another was finding a way to intensify the immune response to Vical’s vaccines, which are designed to stimulate production of T cells in addition to antibodies. The solution was an adjuvant made of lipids, fatty molecules that naturally incite the immune system. What other steps got Vical to this point? Samant shared some insights that offer useful tips to other innovation companies: — Pick a market you can win. At least one Big Pharma player is working on a vaccine to prevent cytomegalovirus infections in healthy women; the virus can cause congenital disabilities when passed from pregnant women to fetuses. Lacking the resources to compete head-to-head, Vical targeted infections in bone marrow transplant patients, a narrow segment worth perhaps $100 million a year - too small to interest traditional vaccine makers. Successful results in transplant patients will position Vical to go after the larger market with a deep-pocketed partner. — Validate your technology on someone else’s dime. Vical obtained government support for high-profile work on vaccines against avian flu and the H1N1 swine flu. The experimental avian flu vaccine promoted a robust immune response in nearly 70 percent of healthy volunteers; Vical is now looking for government money so it can move its swine flu vaccine from animal studies into human trials. Yet Samant was circumspect, even though Vical’s work on sequencing the swine flu virus was attention-grabbing. ”My goal is to demonstrate the value of our technology against a very difficult target,” he said. “If we’re lucky and the government places an order, that’s an upside.”" |
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San Diego Source > News > Adventrx notified of index non-compliance "Adventrx notified of index non-compliance Tuesday, June 2, 2009 Adventrx Pharmaceuticals Inc. (NYSE Amex: ANX) has been notified by staff of the NYSE Amex that it is not in compliance with continued listing standards due to insufficient stockholders' equity and annual net losses" It is a tiny company with only 14 employees and not much going for it as far as I can see. Huge losses and few ideas: from Reuters summary: Summary ADVENTRX Pharmaceuticals, Inc. (ADVENTRX) is a development-stage biopharmaceutical company. The Company’s business is focused on in-licensing, developing and commercializing product candidates for the treatment of cancer. Its lead product candidates, ANX-530 and ANX-514, are emulsion formulations of marketed chemotherapy drugs. ADVENTRX is focused primarily on evaluating strategic options, including the sale or exclusive license of one or more of its product candidate programs, a strategic business merger and other similar transactions. In October 2008, ADVENTRX announced that it had discontinued active work on all product candidates other than ANX-530 and ANX-514. Its wholly owned subsidiaries include SD Pharmaceuticals, Inc. (SDP) and ADVENTRX (Europe) Ltd... I'd say, stay away! There are so many better ideas for speculation. |
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VIP Trader
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Pharmacy Choice - Pharmaceutical News - ADVENTRX Pharmaceuticals Announces Financing - June 11, 2009 Products: ADVENTRX: Products ADVENTRX Pharmaceuticals, Inc. (AMEX:ANX) is the top traded stock and moved up over 12% at $0.23 on 5.8 million shares. In the last five trading session, the stock has gained over 100%. ADVENTRX Pharmaceuticals, Inc. (ADVENTRX) is a development-stage biopharmaceutical company. The Company’s business is focused on in-licensing, developing and commercializing product candidates for the treatment of cancer.
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“The harder the conflict, the more glorious the triumph. What we obtain too cheap, we esteem too lightly; it is dearness only that gives everything its value. I love the man that can smile in trouble, that can gather strength from distress and grow” Epicurus |
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not a problem dtones...
Please don't take it personal. You just happen to be the next person to post and we caught each other again in the same moment. You post a lot of good entries on StockRants! .....No thumbs down from me here. Hope you stop by dtone!! I look forward to reading further posts. |
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VIP Trader
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“The harder the conflict, the more glorious the triumph. What we obtain too cheap, we esteem too lightly; it is dearness only that gives everything its value. I love the man that can smile in trouble, that can gather strength from distress and grow” Epicurus |
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VIP Trader
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They had a good news today, and it looks like they have also a good potential
Winning Brands Chooses Indianapolis for First Launch Into Convenience Stores Winning Brands Chooses Indianapolis for First Launch Into Convenience Stores BARRIE, ONTARIO CANADA Winning Colours Stain Remover Targets Greater Indianapolis for Initial Wave of 100 C-Stores BARRIE, Ontario, June 12 /PRNewswire-FirstCall/ -- Winning Brands Corporation (Pink Sheets: WNBD) (Frankfurt: WMU.F), manufacturer and marketer of advanced eco cleaning solutions, announced today that the race was on to implement its new marketing program called "The Local 100." The aggressive program identifies specific U.S. urban areas in which Winning Brands intends to establish intense local product placement for its breakthrough stain removing solution called Winning Colours Stain Remover. The "Local 100" method focuses on attaining 100 points of sale over any specified 6 week period in an urban market. Indianapolis is the first target market for the program. July 31st is the date set by which to have Winning Colours Stain Remover available in 100 stores in greater Indianapolis. Disclosure: just bought some shares Good Luck ![]() ![]() ![]()
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Senior Trader
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Everything dropping like a rock here except BDSI...
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LinkBack to this Thread: http://www.stockrants.com/forum/us-stock-picks/1085-daily-biopharm-break-out-thread.html
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| Posted By | For | Type | Date | |
| After Years of Red Ink, Vical Says DNA-Based Vaccines ‘Ready for Prime Time.’ | Xconomy | This thread | Refback | 06-11-2009 12:42 PM | |
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