Posts Tagged ‘pharmaceuticals’

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.

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.

BNVI perks, SIRI, FSGI falter

Wednesday, November 10th, 2010

Bionovo Inc. (NasdaqCM: BNVI) climbed 31.68 percent in price to $1.33 near lunch time Wednesday, on volume of 1,604,200 shares, nearly nine times its daily average. The Emeryville, California-based company said Wednesday said the U.S. Food and Drug Administration approved the clinical development plan for its lead drug candidate, Menerba, for treating hot flashes related to menopause.

Sirius XM Radio Inc. (NasdaqGS: SIRI) enjoyed healthy volume of 32,853,681 shares mid-Wednesday, ahead of the pace of its usual daily average volume of 74,982,700 shares. The satellite radio concern saw its stock price falter 2.01 percent to $1.46. Last week, SIRI reported third-quarter revenue of $722.5 million, up 15% from the prior-year quarter, and net income of $67.6 million, compared to a loss of $151.5 million.

First Security Group Inc. (NasdaqGS: FSGI) listed lower by noon ET Wednesday by 22.08 percent in price to $1.20. Volume in FSGI hit 71,627, more than four times its daily average. As of September 30, FSGI reported a third-quarter net loss of $30.2 million resulting in basic and diluted net loss of $1.92 per share for the quarter.

Raptor Pharmaceutical Corp (RPTP) — Buzz Stock of the Day

Monday, May 3rd, 2010

Shares of drug developer, Raptor Pharmaceutical Corp. (Nasdaq: RPTP) were up as much as 58 percent from Friday’s close, in morning trading today after the company announced that a mid-stage study of its liver disease drug met its main goal.

The mid-stage study had 11 adolescent patients with non-alcoholic steatohepatitis, who were given oral doses of up to 1,000 mg of Raptor’s drug twice daily for six months, followed by a six-month post-treatment monitoring period.

The patients had at least twice normal levels of two liver enzymes that are often associated with a presence of liver problems. The patients showed a decline in the level of one enzyme — alanine transaminase (ALT) — during the treatment period, with seven of 11 patients achieving a greater than 50 percent reduction, and in six of 11, the enzyme reduced to within normal range.

Levels of the second enzyme, aspartate aminotransferase (AST), also saw significant improvements with patients seeing 41 percent reduction by the end of the treatment phase.

Raptor is also developing its drug, DR Cysteamine, for genetic disorders like cystinosis and Huntington’s disease.

C.K. Cooper and Co’s Jeffrey Cohen, who is the sole analyst covering Raptor, said Monday’s news does not change his “hold” rating on the stock.

“The net-present value of the pipeline is about $2.88,” Cohen said.

ARCA Biopharma, Inc. (Nasdaq: ABIO) Buzz Stock of the Day

Monday, November 23rd, 2009

Shares of ARCA Biopharma Inc. (Nasdaq: ABIO) surged more than 87 percent in trading Monday after the company announced that the United States Food and Drug Administration (FDA) had given the company fast-track designation for its experimental drug Gencaro, a treatment for chronic heart failure.
The news Monday skyrocketed the shares to a high of $4.50 and ARCA Biopharma topped the Biggest Percentage Price Gainers among common stocks on Nasdaq.

Gencaro, the ARCA’s investigational, pharmacologically-unique beta-blocker and mild vasodilator, is designed to reduce cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population.

Michael R. Bristow, President and Chief Executive Officer of ARCA stated, “Fast Track designation for the Gencaro development program is an important acknowledgement of the need for advancements in the treatment of patients with chronic heart failure, a disease afflicting approximately 6 million people in the United States with approximately 550,000 new cases diagnosed each year.”

The FDA employs fast-track status is to expedite the review of drugs to treat serious diseases and fill unmet medical needs. ARCA plans to submit a study protocol to the USFDA under the administration’s Special Protocol Assessment (SPA) during the fourth quarter of 2009. ARCA expects to commence clinical trials in late 2010 or the first half of 2011 to assess the safety and efficacy of Gencaro in approximately 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro.

Bristow continued, “If the SPA is approved by the FDA and the Company is able to obtain financing, this proposed clinical trial would be the first full sized cardiovascular trial performed in a genetically defined subpopulation to predict efficacy enhancement by the tested drug. As such, the proposed trial would be a landmark undertaking in pharmacogenetic drug development.”

ARCA biopharma began operations in 2005 and is headquartered in Broomfield, Colorado. ARCA is a biopharmaceutical company dedicated to developing genetically targeted therapies for heart failure and other cardiovascular diseases.