Posts Tagged ‘pharmaceutical stocks’

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Vical, Inc. (VICL) surges on news of encouraging animal data

Thursday, September 22nd, 2011

Shares of biopharmaceutical company, Vical, Inc. (Nasdaq: VICL) were up as much as 21 percent from Wednesday’s closing price in mid-day trading on Thursday after teh company announced “encouraging” animal data demonstrating a synergistic improvement in efficacy using a combination of the company’s Allovectin immunotherapy with an anti-CTLA-4 antibody.

Shares of Vical touched an intraday high of $2.98 on Thursday morning, up from Wednesday’s closing price of $2.43.

According to a September 22 press release, treatment with Allovectin plus anti-CTLA-4 antibody provided a synergistic reduction of tumor growth compared with either treatment alone.

“We expected a synergistic effect with this co-treatment, and were pleased that this study confirmed it,” said Alain P. Rolland, Pharm.D., Ph.D., Vical’s Executive Vice President of Product Development in the September 22 press release.

The study was conducted in a well-accepted melanoma mouse model using a standard mouse equivalent of human anti-CTLA-4 antibodies such as ipilimumab. Cohorts included untreated mice, mice treated with Allovectin(R) alone, mice treated with anti-CTLA-4 antibody alone, and mice treated with Allovectin(R) plus anti-CTLA-4 antibody.

Vical, Inc. was founded in 1987 and is based in San Diego, California. Shares of VICL are down about 30 percent over the past three months.

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Transcept Pharmaceuticals Inc. (TSPT) nearly doubles on drug review

Thursday, September 15th, 2011

Transcept Pharmaceuticals Inc. (Nasdaq: TSPT) shares rose 93.7% to $6.47 a day after the drug developer said U.S. regulators might finish a new review of its sleep drug within two months. Volume for the stock exceeded 3.8 million, towering above a daily average of only 235,000.

A news release out Sept. 14 noted that the company, headquartered in Point Richmond, Calif., plans to resubmit to the U.S. Food and Drug Administration (FDA) its New Drug Application (NDA) seeking approval of Intermezzo® (zolpidem tartrate sublingual tablet) for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

The plan to resubmit the Intermezzo® NDA results from a meeting today with the FDA during which the FDA generally agreed with a Transcept proposal to reduce the recommended Intermezzo® dose for women from 3.5 mg to 1.75 mg, and to keep the recommended Intermezzo® dose for men at 3.5 mg. The Transcept proposal also includes new instructions stating that Intermezzo® should only be taken if patients have at least four hours of bedtime remaining, and that patients should refrain from driving for at least one hour after arising and until five hours after dosing Intermezzo®.

In the same release, Transcept CEO Glenn A. Oclassen was quoted as saying “We are pleased that the FDA has expressed general agreement with our proposal to address the concerns expressed in the July 2011 Intermezzo® Complete Response Letter. We look forward to working with the FDA to complete the review of this important new treatment strategy for insomnia characterized by middle of the night awakening.”

Transcept is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience.

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Delcath Systems Inc. (DCTH) shares climb as cancer drug shows promise

Monday, August 22nd, 2011

Delcath Systems Inc. (Nasdaq: DCTH) shares rose 8.5% to $3.96 after it said its experimental cancer treatment showed promising results in a mid-stage trial. Volume for the stock approached 315,000 as noon ET closed in; its all-day average is around 861,000.

A Reuters article published Monday noted that the study included four patient cohorts — hepatobiliary cancers, and metastatic cancers of neuroendocrine, ocular or cutaneous melanoma, and colorectal origins — but responses to the treatment were most encouraging for hepatocellular carcinoma, the most common primary cancer of the liver.

“We believe these results show a strong signal of efficacy, and support our plan to initiate Phase III and Phase IV trials for HCC in the second half of 2012,” Chief Executive Eamonn Hobbs was quoted in the article as saying.

Delcath is developing a chemosaturation system that is designed to administer high dose chemotherapy drugs to only the diseased organs or regions of the body, thereby restricting the harsh effects of chemo drugs on other body organs.

Delcath, headquartered in midtown Manhattan, is a development-stage, specialty pharmaceutical and medical device company focused on oncology. We’re researching breakthroughs in regional chemotherapies with the goal of improving clinical outcomes and potentially reducing drug-related adverse events.

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Orexigen Therapeutics Inc. (OREX) stock price balloons for diet pill maker

Wednesday, June 1st, 2011

Orexigen Therapeutics Inc. (Nasdaq: OREX) shares jumped 17.7% to $3.33 Wednesday, after the diet-pill developer said it would make a regulatory announcement about its obesity treatment in two days. Volume for the stock was 8.2 million shares, or more than six times its daily average.

The San Diego-based Orexigen has announced a regulatory update on Friday, June 3, before the markets open. The announcement will be followed by a live webcast and conference call at 8:00 a.m. Eastern time. No one from Orexigen management was immediately available for comment.

The company’s lead product, Contrave®, has completed Phase 3 clinical trials and has received a Complete Response Letter from the FDA for its New Drug Application. The Company is in the process of determining the next steps for Contrave.

The Company’s second product, Empatic™, has completed Phase 2 clinical development. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss, through combination therapeutic approaches.

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DUSA Pharmaceuticals (DUSA) stock spikes on earnings report

Thursday, May 5th, 2011

DUSA Pharmaceuticals Inc. (Nasdaq: DUSA) shares rallied 22.5% to $5.55, after the developer of dermatology products reported first-quarter results. Volume for the stock topped 2.2 million shares shortly before Thursday’s close, compared to a daily average of 350,000.

The company, based out of Wilmington, Massachusetts, reported total product revenues were $11.1 million for the quarter, representing a $2.4 million or 27% year-over-year improvement, and experienced a net loss on a GAAP basis of $600,000 or $0.02 per common share for the first quarter of 2011, compared to a net loss of $400,000 or $0.02 per common share in the first quarter of 2010.

According to DUSA Chief Executive Officer Robert Doman, “We are off to a great start in 2011. Continued growth of our core domestic PDT revenues, as well as record gross margins, drove significant year-over-year improvement in our non-GAAP profitability and cash flow.” Doman concluded, “The results of the quarter are even more impressive given the fact that they followed our record performance of the fourth quarter of 2010.”

DUSA Pharmaceuticals, Inc. is an integrated dermatology pharmaceutical company focused primarily on the development and marketing of its Levulan® PDT technology platform, and other dermatology products. Levulan® Kerastick® for topical solution plus DUSA’s BLU-U® Blue Light Photodynamic Therapy Illuminator is currently approved for the treatment of minimally to moderately thick actinic keratoses (AKs) of the face or scalp.

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