Posts Tagged ‘pharma stocks’

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DepoMed, Inc. (DEPO) -Buzz Stock of the Day

Monday, January 31st, 2011

Shares of drug maker DepoMed, Inc. (Nasdaq: DEPO) surged as much as 37 percent from Friday’s closing price in morning trading on Monday after the company announced that its one-a-day pain drug for shingles, Gralise was approved by the U.S. Food and Drug Administration. The announcement was made last Friday at 7:30 p.m. EST.

“Importantly, the label stated that Gralise is not interchangeable with other gabapentin products. We view this as a major victory that is preventing substitution at the pharmacist level,” Roth Capital Partners analyst Scott Henry told Reuters.

Shares of DepoMed climbed as high as $8.60 per share, up from Friday’s closing price of $6.24. Shares opened markedly higher, at $8.50 on Monday.

The drug is licensed to Abbot Products, Inc. (NYSE: ABT) in the U.S., Canada and Mexico, and the FDA approval triggers a milestone payment of $48 million from Abbott to Depomed.  The licensing deal also includes sales milestone payments of up to $300 million, and calls for Depomed to receive royalties of 14 percent-20 percent on sales of Gralise.

“We are delighted with the approval of Gralise, which marks the third FDA approval of a product developed by DepoMed. Further, FDA has granted GRALISE Orphan Drug status, recognizing GRALISE as an important treatment option for patients who suffer from the pain of PHN,” said Dr. Michael Sweeney, DepoMed’s Vice President of Research and Development, in a statement. ” We are also very pleased with the product label FDA has approved.”

DepoMed’s other FDA approved drugs include Glumetza for the treatment of type 2 diabetes in the United States and Canada; and Proquin XR for the treatment of uncomplicated urinary tract infection in the United States.

The Menlo Park-based company also has collaboration and license agreements with Solvay Pharmaceuticals, Inc.; PharmaNova, Inc.; Santarus, Inc.; Merck & Co., Inc.; Covidien, Ltd.; TEVA Pharmaceuticals USA, Inc.; King Pharmaceuticals, Inc.; Esprit Pharma, Inc.; LG Life Sciences, Ltd.; Rottapharm/Madaus S.r.l.; PharmaNova, Inc.; and Supernus Pharmaceuticals, Inc.

Shares of Depomed, Inc. are up about 65 percent over the past three months.

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Avanir Pharmaceuticals, Inc. (AVNR) – After-hours Buzz Stock of the Day

Friday, October 29th, 2010

Shares of Avanir Pharmaceuticals, Inc. (Nasdaq: AVNR) were up more than 15 percent in after-hours trading on Friday after it was reported on TheStreet.com that the U.S. Food and Drug Administration approved Avanir’s Nuedexta for the treatment of pseudobulbar affect.

Pseudobulbar affect (PBA), sometimes called emotional incontinence refers to a neurologic disorder characterized by involuntary crying or uncontrollable episodes of crying and/or laughing, or other emotional displays. Prevalence estimates place the number of people with PBA between 1.5 million and 2 million in the United States alone. However, given the fact that PBA is a relatively common disorder among patients with various neurologic conditions, its actual prevalence may be higher.
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Carol Werther of SummerStreet Research Partners, an independent healthcare research firm, predicted the approval in an Oct. 15 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.”

Nuedexta, formerly known as AVP-923 and the trade name Zenvia™, is a combination of two well-characterized compounds, 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.

“The FDA approval of NUEDEXTA marks an important milestone for people living with PBA, an under-recognized and debilitating neurologic condition,” said Keith Katkin, president and chief executive officer of Avanir in a statement. “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.”

Shares of Avanir Pharmaceuticals are down about 13 percent in the past three months.

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MIPS, APPY, RFMD, SHMN – Buzz Stocks With Big Gains This Week

Friday, October 29th, 2010

Several of this week’s Buzz Stocks have had a string of days with solid gains:

MIPS Technologies, Inc. (Nasdaq: MIPS) – Shares of MIPS Technologies 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. Shares closed on Tuesday at $14.12, after rallying as high as $14.18. The next day, shares spiked to $14.65, before closing at $14.34. Shares of MIPS Technologies have are up about 40 percent since Monday.

AspenBio Pharma, Inc. (Nasdaq: APPY) – 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. Shares traded as high as 98 cents, before closing at 71 cents on Tuesday. Shares traded between 80 cents 61 cents on Wednesday and Thursday, and were trading at 69 cents in mid-day trading on Friday. Shares of AspenBio Pharma, Inc. are up about 86 percent since Monday.

RF Micro Devices, Inc. (Nasdaq: RFMD) – Shares of RFMD were up 13 percent in morning trading on Wednesday after the company posted revenue of $285.8 million, and EPS of 19 cents for its fiscal second quarter ended October 2. Analysts on average expected EPS of 16 cents, on revenue of $275.9 million. Since then, shares have continually moved higher, trading as high as $7.45 on Thursday. At mid-day Friday, shares of RFMD were trading at $7.39, up about 11 percent since Monday.

SOHM, Inc. (Pink Sheets: SHMN) – The generic drug maker had several news releases this week announcing its intent to capitalize on the market opportunity in India for the company’s products. On Thursday,SOHM announced the addition of six new generic pharmaceutical products targeting asthma and respiratory disease. Shares of SOHM rallied as high as 9 cents on Thursday, before closing at 6 cents per share. Trading volume on Thursday was 10.5 million shares, a significant increase over SOHM’s average three-month trading volume of 165,398 shares. Shares of SHMN are up approximately 60 percent since Monday.

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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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