Posts Tagged ‘Biotech Stocks’

UPDATE — Molecular Insight Pharmaceuticals, Inc. (MIPI) – Buzz Stock of the Day

Thursday, June 24th, 2010

We first featured Molecular Insight Pharmaceuticals, Inc. (Nasdaq: MIPI) on June 18th, after the company announced nonclinical data demonstrating the utility of the Company’s novel radiopharmaceutical compounds for the molecular imaging of prostate and other tumors at the Society of Nuclear Medicine (SNM) annual meeting in Salt Lake City.

Less than a week later, Molecular Insight Pharmaceuticals announced positive data from a completed Phase 2a clinical study of Azedra™, the Company’s lead oncology therapeutic for a common childhood cancer. Shares were up more than 65 percent from Wednesday’s closing price, in morning trading on Thursday on almost 10-times the company’s average three-month trading volume.

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The company said data from the Azedra study showed that doses of 12 millicurie/kg to 18 millicurie/kg of the drug were tolerated without toxicity and the drug was active in tumors. The main goal of the study was to determine the maximum tolerated dose of Azedra.

“We showed that Ultratrace iobenguane I-131 with AHSC support is feasible at 18 mCi/kg without significant toxicity and with promising partial and complete responses that support proceeding to a pivotal Phase 2 study at18 mCi/kg,” said lead investigator Katherine K. Matthay, M.D., the Mildred V. Strouss Professor of Translational Cancer Research and Chief, Pediatric Hematology-Oncology in Department of Pediatrics at the University of California, San Francisco.

Azedra is currently in advanced clinical trials for the treatment of malignant pheochromocytoma, a rare, hard-to-access neuroendocrine tumor that develops in the core of an adrenal gland.

EnteroMedics, Inc. (ETRM) – Buzz Stock of the Day

Tuesday, June 22nd, 2010

Shares of medical device maker, EnteroMedics, Inc. (Nasdaq: ETRM) soared 75 percent from Monday’s closing price, in morning trading on Tuesday after the company announced positive data from an ongoing feasibility study of the Maestro System in obese patients with Type-2 diabetes mellitus. The study was designed to evaluate the safety and efficacy of the Company’s next-generation Maestro RC System, which treats obesity.

James Toouli, M.D., professor of surgery at Flinders University in Adelaide, Australia, and one of the study’s investigators said the results from the study showed “significant, sustained improvements in glycemic control and blood pressure as well as clinically meaningful weight loss, without a compromise in patient safety.”

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Data from the Empower study, in which over 400 patients have used the Maestro System device, showed significant weight loss and control of obesity related co-morbidities.

EnteroMedics’ device, which is implanted laparoscopically, blocks the vagus nerves periodically using high-frequency, low-energy electrical impulses.

“Across a number of studies, we have observed clinically significant weight loss and control of obesity related co-morbidities as well as a safety profile that distinguishes this system from all other bariatric surgical procedures. We are particularly encouraged by the strong, positive feedback from the metabolic and bariatric surgery community,” said EnteroMedics’ President and CEO Mark B. Knudson, Ph.D in a statement.

Penwest Pharmaceuticals Co. (PPCO) – Buzz Stock of the Day

Tuesday, June 8th, 2010

Shares of drug maker, Penwest Pharmaceuticals Co. (Nasdaq: PPCO) were up as much as 21 percent in morning trading on Tuesday after the company announced that it settled a patent litigation with Impax Laboratories, Inc. (Nasdaq: IPXL) over the production and sale of a generic version of the pain drug Opana, which is jointly developed by Penwest and Endo Pharmaceuticals Holdings, Inc. (Nasdaq: ENDP).

Penwest shares rose as high as $3.38, up from Monday’s closing price of $2.78 per share.

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Penwest and Endo have agreed to grant Impax a license to sell the copycat on Jan. 1, 2013. Impax will have 180 days of marketing exclusivity for 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets of the drug, Reuters reported. Impax could also get up to $40 million in milestones from Endo for an Impax brand drug the two companies will promoted together outside the field of neurology. Further terms of the settlement were not disclosed.

Endo and Penwest also settled a similar patent litigation with Sandoz Inc, a unit of Swiss drugmaker Novartis AG (NOVN.VX), granting Sandoz a license to sell the generic of the drug on Sept. 15, 2012.

Neurocrine Biosciences, Inc. (NBIX) – Buzz Stock of the Day

Tuesday, May 25th, 2010

Shares of drug developer, Neurocrine Biosciences, Inc. (Nasdaq: NBIX) were up 54 percent in morning trading on Tuesday, after the company announced “statistically significant and clinically meaningful” top-line efficacy results from its Daisy PETAL phase II study of elagolix, a treatment for patients with endometriosis.

The San Diego-based company said the drug, elagolix, showed statistically significant reductions in pelvic pain during menstruation, and non-menstrual pelvic pain and dyspareunia, or painful intercourse, when compared to placebo. The US based Daisy PETAL study enrolled 137 endometriosis subjects into one of two treatment groups; elagolix 150 mg or placebo once daily for two months of treatment, in a double-blind design. Subjects are continuing for four months of open-label elagolix treatment and assessments. These top-line efficacy results are based on the ITT population of 132 women.

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Shares began rallying in after-hours trading on Monday, after the company issued its announcement.

“The Daisy PETAL study was successful, all primary and secondary efficacy endpoints were met, and provided exactly the information we need to move this program forward,” said Chris O’Brien, M.D., Chief Medical Officer at Neurocrine in a statement. “We now have confirmation that the daily scales for menstrual and non-menstrual pelvic pain, developed with extensive input from the FDA and patients, function well in a clinical trial setting. These daily endpoints reflect the way women with endometriosis experience their symptoms and also demonstrate improvement with elagolix.”

Shares of NBIX have been up as much as 58 percent in the past three months.

Vasomedical, Inc. (VASO) – Penny Stock of the Day

Monday, May 24th, 2010

Shares of Vasomedical, Inc. (OTCBB: VASO) were up as much as 86 percent on Monday after the company announced that its subsidiary was appointed the exclusive representative for select GE Healthcare Diagnostic Imaging products to specific market segments in the 48 contiguous states of the United States and District of Columbia received signed a sales representative agreement. GE Healthcare is the healthcare business unit of GE (NYSE: GE – News). The Company has already received financial commitments for up to $5 million to fund this project.

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“This representation agreement is an example of Vasomedical’s strategy to expand its operations into new areas of potential growth in healthcare,” stated Abraham E. Cohen, Chairman of the Board of Vasomedical, Inc. in a statement.

The agreement is for an initial term of three years commencing July 1, 2010, subject to extension and also subject to earlier termination under certain circumstances.

Vasomedical, Inc. is primarily engaged in designing, manufacturing, marketing and supporting EECP(R) external counterpulsation systems based on the Company’s proprietary technology. Offered exclusively by Vasomedical, EECP therapy is a safe, non-invasive, outpatient treatment option for patients suffering from ischemic heart diseases such as angina and heart failure

In early April, the company announced that it received clearance from the U.S. Food and Drug Administration to market its Vasomedical-BIOX™ Model 2301 Combined ECG Holter and Ambulatory Blood Pressure Monitoring Recorder and Software Analysis System.

“These are the first in a line of Vasomedical-BIOX™ ECG Holter and Ambulatory Blood Pressure Monitoring Systems that Vasomedical intends to bring to the marketplace,” said Dr. Jun Ma, President and CEO of Vasomedical, Inc.

Shares of Vasomedical are up more than 300 percent over the past 12 months.