Posts Tagged ‘Biotech Stocks’

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AspenBio Pharma, Inc. (APPY) – Buzz Stock of the Day

Tuesday, October 26th, 2010

Shares of diagnostic products maker, AspenBio Pharma, Inc. (Nasdaq: APPY) were up as much as 71 percent from Monday’s closing price, in morning trading on Tuesday after the company announced that it initiated manufacturing on its AppyScore™ cassette-based test system, and added personnel to handle its clinical, regulatory and commercial planning efforts.

“Aspen has made significant progress advancing the AppyScore cassette-based test and we are excited to put the test in the hands of actual hospital users for feedback as we proceed towards our pivotal clinical trial,” said Steve Lundy, President and Chief Executive Officer in a statement.
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AppyScore™ is a rapid, blood-based test designed to assist doctors in assessing the low risk population of emergency room patients suspected of having acute appendicitis when presenting with abdominal pain.

According to AspenBio’s Web site, up to 18% of patients are misdiagnosed and sent home with appendicitis; 8 – 10% of surgeries remove a normal appendix; women are more difficult to diagnose than men and the negative appendectomy rate is significantly higher in women; an estimated 1 million patients present annually with a low risk for acute appendicitis and are exposed to unnecessary CT scan radiation—a potentially significant health risk.

The Colorado-based company also appointed Michael Wandell, PharmD to lead its human diagnostic products’ clinical and regulatory strategy, and Erik Miller to head the company’s commercial planning efforts, including pre-clinical field testing of the AppyScore system.

Shares of AspenBio Pharma, Inc. are up about 44 percent since October 1.

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Notable Nasdaq Gainers – APPY, MIPS, SUPG, MCOX

Tuesday, October 26th, 2010

AspenBio Pharma, Inc. (Nasdaq: APPY) shares are up more than 125 percent since October 18th. Shares opened this morning at $0.60 and surged as high as $0.98. The company issued a news release this morning before the opening bell announcing that it has initiated manufacturing of its AppyScore™ cassette-based test system to be used in further validation and verification testing. AppyScore is a blood-based diagnostic test designed to aid emergency department physicians in the difficult challenge of evaluating patients suspected of having appendicitis. AspenBio Pharma also announced that it has contracted with Michael Wandell, PharmD to lead its human diagnostic products’ clinical and regulatory strategy, and Erik Miller to spearhead the company’s commercial planning efforts.

MIPS Technologies, Inc. (Nasdaq: MIPS) shares increased almost 24 percent from Monday’s closing price in morning trading on Tuesday after the chip maker announced first quarter  profit of  $7.6 million, or 16 cents per share, compared with $595,000, or a penny per share, a year earlier. Excluding one-time items, MIPS earned 17 cents per share. Analysts polled by Thomson Reuters expected earnings of  7 cents per share. MIPS Technologies’ quarterly revenue jumped 50 percent to $22.5 million, largely driven by a big jump in royalties revenue. Analysts expected $19.7 million in revenue. Shares of MIPS are up about 113 percent over the past 12-months.

SuperGen, Inc. (Nasdaq: SUPG) shares were up as much as 27 percent from Monday’s closing price in morning trading on Tuesday, after the oncology-focused biotech company announced better-than-expected third-quarter profit, driven by by royalty revenue from its blood cancer drug, Dacogen. Third-quarter net income increased  to $3.9 million, or 6 cents a share, from $833,000 or 1 cent a share, a year ago. Revenue in the quarter rose 29 percent to $13.4 million. Royalty revenue from Dacogen rose was up $2.8 million to $13.2 million. Analysts on an average were expecting a loss of a penny per share on revenue of $11.18 million. SuperGen also raised its outlook for 2010. The company expects full-year profit of less than $12 million, up from its previous estimate of less than $4.5 million. SuperGen expects royalty revenue from Dacogen to be between $49 million and $52 million, up from its previously estimated range of $44 million to $48 million.

Mecox Lane Limited (Nasdaq: MCOX) shares had a great debut on Tuesday, opening nearly 60 percent above its initial public offering price. Mecox, which sells clothing and accessories to young  women, sold 11.74 million American Depositary Shares for $11 each, raising about $129.17 million. Shares soared as high as $18.50 in morning trading on Tuesday. Credit Suisse Securities (USA) LLC and UBS AG acted as joint bookrunners for the offering. Oppenheimer & Co. Inc. and Roth Capital Partners, LLC acted as co-managers for the offering. Mecox Lane’s website, M18.com, sells proprietary brands including Euromoda and Rampage, and well-known third party brands including Adidas and Daphne. The company had about 2.1 million active online customers as of June 30. For the six months ended June 30, Mecox Lane posted net revenue of $108.03 million, up 41.6 percent from a year earlier. Net income for the same period fell 37.7 percent to $2.53 million, from a year earlier.

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PharmAthene, Inc. (PIP) – Buzz Stock of the Day

Monday, October 18th, 2010

Shares of biodefense company PharmAthene, Inc. (AMEX: PIP) soared almost 32 percent from Friday’s closing price, in morning trading on Monday after WBB Securities upgraded its rating on the stock to a Strong Buy. The tailwind for PharmAthene began last week after it was announced that the  NYSE Amex LLC (NYSE Amex) determined that the Company made a reasonable demonstration of its ability to regain compliance with the  NYSE Amex listing requirements and granted PharmAthene an extension until January 26, 2012 to demonstrate its compliance.

PharmAthene also caught a huge boost from last week’s news that the United States is spending up to $2.8 billion to shore up its defenses against biological warfare, according to SIGA Technologies, Inc. (Nasdaq: SIGA), the drugmaker who expects to get a government contract to supply smallpox antiviral drugs.In December 2006, PharmAthene had filed a case against SIGA pursuant to a merger agreement between the companies that was terminated in October 2006. The trial is expected to start on Jan. 3, 2011. Noble Financial Capital Markets analyst Raghuram Selvaraju expects the court case with PharmAthene to be ruled in its favor, with PharmAthene getting a percentage of SIGA’s contract with the government. Roth Capital Partners analyst Joseph Pantginis said the contract has positive implications to PharmAthene that can now identify the exact measure of potential damages.
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TheStreet.com’s James Altucher recently wrote that on the basis of this contract alone, Pharmathene would potentially make up to a billion dollars in cash earnings. “On this one catalyst I think PIP is potentially a $7 – $12 stock,” he stated in his October 15, 2010 article.

PharmAthene is also positioning its anthrax vaccine, Valortim, as a potential alternative to the existing vaccine that is administered to military personnel and individuals who work in high-risk environments. Anthrax is considered the Department of Defense’s No. 1 biological threat.  The US is required to have a stockpile of 75 million doses of vaccine. Right now, the only approved supplier of doses of vaccine is EBS, which has a long-approved first-generation vaccine that requires 5 doses over 18 months and costs $120 per dose. PIP’s second-generation vaccine requires 3 doses over 60 days and costs about $45 a dose, according to PharmAthene’s Chief Executive Officer, Eric Richman.

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Celldex Therapeutics, Inc. (CLDX) – Buzz Stock of the Day

Tuesday, October 5th, 2010

Shares of cancer drug developer, Celldex Therapeutics, Inc. (Nasdaq: CLDX) were up as much as 22 percent from Monday’s closing price, in morning trading on Tuesday after the company announced positive data for its cancer therapy CDX-1401.

“CDX-1401 represents a new generation of off-the-shelf dendritic cell targeted vaccines built upon excellent preclinical activity data,” said Tom Davis, M.D., Chief Medical Officer of Celldex Therapeutics in a statement. ““The initial data from this ongoing study confirm safety and immunogenicity even in patients with advanced cancer who have received multiple prior therapies. CDX-1401 has passed the initial Phase 1 hurdles and we look forward to forthcoming cohorts that will include additional TLR agonists in combination regimens.”

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CDX-1401 is a cancer vaccine designed to activate a patient’s immune system against cancers including melanoma and other cancers that are known to express the tumor antigen NY-ESO-1. The product consists of a fully human monoclonal antibody with specificity for the dendritic cell receptor, DEC-205, genetically linked to the NY-ESO-1 tumor antigen. Celldex has accessed NY-ESO-1 through a multi-year clinical research collaboration with the international Ludwig Institute for Cancer Research. By selectively delivering the NY-ESO-1 antigen to dendritic cells in the body, this product is intended to induce robust immune responses against the antigen-expressing cancer cells.

Here’s Forbes’ report on the data:

The data presented were from a Phase 1/2 dose-escalating clinical trial evaluating three different doses of the vaccine in combination with resiquimod , which is an activator of toll-like receptors 7 and 8 (TLR7/8) and stimulator of immune cells. The study has enrolled 20 patients with advanced cancer, of which 35% had confirmed NY-ESO-1 expression. Six patients maintained stable disease and were eligible for multiple cycles of the treatment regimen, including 4 patients who have received 3 or more cycles (6 weeks of treatment followed by a 6 week rest), with stable disease of up to 11.5+ months. The treatment was well tolerated and there were no dose-limiting toxicities. Robust anti-NY-ESO-1 immunity was induced with the majority of the patients developing anti-NY-ESO-1 antibody responses and 39% of the patients having increases in NY-ESO-1 specific T cell responses, including both CD4 and CD8 responses. Importantly, the T cell responses were directed against multiple regions of the NY-ESO-1 antigen.

Last month, Celldex’s partner Pfizer Inc (NYSE: PFE) pulled out of a strategic partnership to develop the vaccine, and the company said it now plans to develop it on its own.

The finding is yet another example of the potential of cancer immunotherapies — treatments that recruit the immune system to fight cancer.

Earlier this year, the U.S. Food and Drug Administration approved Dendreon Corp’s (Nasdaq: DNDN) prostate cancer therapy Provenge, the first cancer vaccine. Bristol-Myers Squibb Co’s (NYSE: BMY) immune system treatment ipilimumab also helped to extend the lives of patients with aggressive melanoma, the deadliest form of skin cancer for which there are few treatment options.

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EntreMed, Inc. (ENMD) – Buzz Stock of the Day

Thursday, August 19th, 2010

Shares of oncology-focused drug developer, EntreMed, Inc. (Nasdaq: ENMD) were up as much as 28 percent from Wednesday’s closing price in morning trading on Thursday. The company recently announced a second quarter net loss of $4.9 million, or 62 cents per share, compared with a net loss of $3.1 million, or 46 cents per share for the same period a year ago.

According to EntreMed’s Executive Chairman, Michael Tarnow, the second quarter was “pivotal” for the company. “During the second quarter, we achieved a critical milestone with the initiation of a multi-center Phase 2 study for ENMD-2076 in ovarian cancer patients,” he said in a statement.
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ENMD-2076 is an orally-active, Aurora A/angiogenic kinase inhibitor with a unique kinase selectivity profile and multiple mechanisms of action. Preclinical studies with ENMD-2076 demonstrated significant antitumor activity, including tumor regression, in multiple solid and hematological malignancies. ENMD-2076 has been shown to inhibit a distinct profile of angiogenic tyrosine kinase targets in addition to the Aurora A kinase. Aurora kinases are key regulators of mitosis (cell division), and are often over-expressed in human cancers.

Last month, the company announced the publication of preclinical data for its Phase 2 oncology drug candidate, ENMD-2076 an Aurora A/angiogenic kinase inhibitor, which demonstrated significant activity against multiple myeloma (MM) cell lines and in MM models in vivo. Results of the study, conducted by EntreMed’s collaborator, Sherif Farag, M.D., Ph.D., and colleagues at the Indiana University School of Medicine, were published in the on-line version of the British Journal of Haematology on June 15, 2010 and were scheduled to be published in print in the August 1.

For the first six months of 2010 the reported net loss was ($7.1 million), or ($0.95) per share as compared to ($6.6 million), or ($0.98) per share for 2009.

As of June 30, 2010, EntreMed had cash and short-term investments of approximately $8 million.

EntreMed announced a 1-for-11 reverse stock split on June 30, 2010, to better enable the company to maintain its listing on the Nasdaq Capital Market. As a result of the reverse split, the number of shares of outstanding common stock will be approximately 9.5 million, excluding stock options and unexercised warrants and subject to adjustment for fractional shares.

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