Generex Biotechnology Corp. (GNBT) spins out, stock points higher

Posted on: September 15th, 2011
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Generex Biotechnology Corp. (OTCBB: GNBT) saw its shares gain 8.7% to 9.89 cents, as Thursday’s markets closed, on news of the spinout of one of its subsidiaries. Volume for the stock was 1.3 million shares, nosing out its full-day average.

A news release dated Sept. 15 announced that the company, based in Worcester, Mass., provided an update on the status of the previously announced spinout of its wholly-owned subsidiary, Antigen Express, Inc.

The Company is in the midst of a detailed and comprehensive review of several transaction opportunities, including both shell companies and operating biotech companies with synergistic intellectual properties, in each case Securities and Exchange Commission registrants and Depository Trust Company eligible companies, into which Antigen Express will be merged.

Generex CEO Mark Fletcher, “We are undertaking our due diligence examination of available alternatives with a view to identifying an appropriate transaction for the Antigen Express spinout.

“We will proceed with expedition to negotiate an agreement with the target company, complete the merger of Antigen Express into that company, and conduct an initial fund raising. If the merger and the initial fund raising are successful, we will then seek a listing of the merged company’s stock on a national stock exchange.”

Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies.

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RXi Pharmaceuticals Corporation (RXII) clinical trials to continue, shares jump

Posted on: September 12th, 2011
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RXi Pharmaceuticals Corporation (Nasdaq: RXII) shares gained 12% to $1.12 Monday, after favorable news about the company’s breast cancer vaccine trial. Volume for the stock exceeded 3.5 million shares, compared to a daily average of 722,000.

A story published Monday in Boston Business Journal revealed that the U.S. Food and Drug administration has cleared the way for the start of Rxi to launch its Phase 3 trial studying a potential vaccine for a certain type of breast cancer.

If successful, the vaccine would provide an alternative for women who have low to intermediate expression of the HER2 mutation, and are not eligible for the blockbuster drug Herceptin, made by Swiss drug maker Roche AG.

The FDA has now lifted a partial clinical hold the agency put on the chemistry, manufacturing and controls associated with the vaccine trial.

Worcester, Mass.-based RXi acquired the potential vaccine, called NeuVax, when it bought Scottsdale, Ariz.-based Apthera. As part of the deal, Apthera’s shareholders initially received approximately 4.8 million shares of Worcester, Mass.-based RXi’s common stock, worth $7.2 million at the time, on March 30. The deal closed in April. Apthera’s stockholders will also be entitled to contingent payments tied to clinical, regulatory and commercial milestones connected to NeuVax.

The partial clinical hold was placed on the vaccine candidate before it was acquired by RXi, and its lifting will allow the company to start its Phase 3 trial in the first half of 2012. The study is expected to include about 100 trial sties in the U.S., Canada and Europe.

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Cytomedix Inc. (CMXI) bolts higher on latest news

Posted on: September 1st, 2011
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Cytomedix Inc. (OTCBB: CMXI) shares jumped 8.6% to 38 cents Thursday, on exciting news surrounding its Angel® Whole Blood Separation System. Volume for the stock approached its full-day average of around 65,900 shares by noon ET.

The company, located in Gaithersburg, Md., issued a news release Thursday, in which it announced today the recent submission of a 510(k) to the U.S. Food and Drug Administration (“FDA”) for use of the Angel® Whole Blood Separation System for processing a bone marrow aspirate. The expanded indication includes processing a mixture of blood and bone marrow, a rich source of stem cells.

In vitro performance testing supporting the 510(k) compared Cytomedix’s Angel System to the predicate device for preparing platelet rich plasma (“PRP”) from blood and bone marrow.

The test results yielded statistically significant data showing the Angel System: increased the concentrations of hematopoietic progenitor/stem cells; reduced the presence of pro-inflammatory cells that can be detrimental for treating certain medical indications; and provided better separation of PRP and red blood cells compared with the predicate device.

The release quoted Cytomedix CEO Martin Rosendale as saying, “We are pleased to have filed this 510(k) for a bone marrow concentrate indication as it expands the versatility and competitive positioning of the Angel System for both new and existing customers. Importantly, this indication serves a number of large markets that we believe the Angel System is well-poised to penetrate.”

Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis.

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SOYL grows, ILNS deals, WWBP sinks

Posted on: April 11th, 2011
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American Soil Technologies Inc. (OTCBB: SOYL) rocketed 168.3% to 1.1 cents by noon ET Monday. Volume for the stock was 20,000 shares, or three times its daily volume. SOYL is the leading supplier of super-absorbent polymer soil amendments and other applicable products in the multi-billion-dollar turf, retail horticulture, and agriculture markets.

Intellect Neurosciences Inc. (Pink Sheets: ILNS) dealt in 84.1 million shares by midday Monday, or five times its full-day average. Prices vaulted 38.5% to 18-100ths of a cent, only a week after ILNS received a new patent from the Israeli Patent and Trademark Office related to OX1, the Company’s clinical-stage drug candidate.

Worldwide Biotech & Pharmaceutical Company (Pink Sheets: WWBP) saw its share price halved to three-100ths of a cent Monday, on volumes of 50,000 shares, routing a daily average around 1,780.

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Avanir Pharmaceuticals (AVNR) skyrockets on rumors of FDA approval

Posted on: October 29th, 2010
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A late-breaking report posted on had Avanir Pharmaceuticals, Inc. (Nasdaq: AVNR) abuzz in after-hours trading Friday. The financial news website reported that the United States Food and Drug Administration (FDA) approved Avanir’s Nuedexta, a treatment for a relatively common, yet under-recognized neurological disorder known as Pseudobulbar affect (PBA).

Shares of Avanir were up 15 percent on Friday, in what has been a particularly rough quarter for pharmaceutical stocks. Before Friday, shares of Avanir Pharmaceuticals were down about 13 percent in the past three months.

In a statement, Keith Katkin, President and Chief Executive Officer of Avanir said “The FDA approval of Nuedexta marks an important milestone for people living with PBA, an under-recognized and debilitating neurologic condition. The approval of Nuedexta also marks Avanir’s transition toward becoming a commercial enterprise, ready to support the successful launch of the first FDA-approved treatment for PBA. We expect that Nuedexta will be available by prescription during the first quarter of 2011.”

Formerly known as AVP-923, is a combination of two-well researched components, the active ingredient dextromethorphan, and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. Avanir is developing Nuedexta for use in PBA and diabetic peripheral neuropathic pain.

Pseudobulbar affect (PBA) is a neurologic disorder characterized by involuntary crying or uncontrollable episodes of crying and/or laughing, or other emotional displays, the condition is also referred to as emotional incontinence. Research suggests that as many as 1.5 million and 2 million people may be afflicted with PBA in the United States alone, although, it is estimated that the number could be much higher due the prevalence of PBA in numerous neurological conditions.

Independent research firm for the healthcare industry, SummerStreet Research Partners predicted such an approval, on October 15. Analyst Carol Werther stated in a note to clients: “We expect a label to treat the signs and symptoms of PBA with warnings not to use with drugs that increase QTc wave prolongation,” the note stated. “Data from the advanced cardiac safety study (ACSS) indicates that AVP-923, even using a 10mg dose of quinidine, still prolongs the QTc (mean of 8.9 ms), just above the level the FDA considers no risk for Torsades de Pointes. (5 msec). Nevertheless, we do not think this will stop approval as many marketed drugs have similar profiles. AVNR submitted a risk map program to prevent abuse of AVP-923.”

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Sinobiopharma (SNBP) reports strong fiscal year 2010 financials

Posted on: September 21st, 2010
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Share prices for Sinobiopharma, Inc. (OTCBB: SNBP) are up 15.4 percent from last week, to 30 cents a share, after the company announced promising financial results, with solid increases in revenues and profits driven by higher sales of their flagship product, KuTai, a muscle relaxant. The Company is pleased to report 2010 revenue rose 101 percent to $7.7 million, and net income increased approximately $5.1 million year-over-year to $2.9 million, or three cents per diluted share.

Sinobiopharma, a fully integrated and innovative specialty pharmaceutical company engaged the development and distribution of biopharmaceutical products in China, also reported that their gross margin increased 142 percent year-over-year to approximately $6.2 million, or 80 percent of sales from $2.5 million in contrast to $2.5 million, or 66 percent during the same period of 2009. Additionally, net worth increased from $776,831 at May 31, 2009 to $9,752,831 at May 31, 2010. Total assets increased by $5,996,519, from $5,956,443 at May 31, 2009 to $11,952,962 at May 31, 2010.

Dr. Lequn Lee Huang, Sinobiopharma’s Chairman and CEO, commented on the fiscal year 2010 results, “This has been a great year for Sinobiopharma. The market has demonstrated a strong need for our flagship product – KuTai – and the sales increases from this product are expected to continue for the next two years. The cash flow generated organically is expected to fully support ongoing operations.”

Sinobiopharma’s current therapeutic focus is on anesthesia-assisted agents and cardiovascular drugs. The company is known as Dong Ying (Jiangsu) Pharmaceutical Co., Ltd., Sinobiopharma’s wholly-owned subsidiary in China, one of the world’s fastest growing pharmaceutical markets.

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