Posts Tagged ‘FDA’

Keryx Biopharmaceuticals, Inc. (KERX) – Hot Buzz Stock of the Day

Wednesday, July 14th, 2010

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Shares of Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) climbed as much as 17 percent in morning trading Wednesday after the after the company announced its experimental childhood cancer drug, KRX-0401 (perifosine), had received Orphan Drug designation from U.S. Food and Drug Administration (FDA).

Commenting on receiving Orphan Drug designation, Ron Bentsur, Chief Executive Officer of Keryx stated, “We are currently exploring next steps for the development of perifosine in this indication which we hope, ultimately, could provide a new treatment option for children and infants suffering with neuroblastoma.

The FDA grants Orphan Drug status to new drugs that treat a rare disease afflicting fewer than 200,000 patients in the U.S. The benefits of Orphan Drug designation include seven-year marketing exclusivity if the drug is the first of its kind approved, tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

KRX-0401 is being developed for the treatment of neuroblastoma, a cancer of the nervous system affecting mostly children and infants. Although it is a rare form of cancer, neuroblastoma accounts for approximately 7 percent of all cancer deaths among children.

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Clinical Phase 1 data was presented last month in the pediatric solid tumor poster discussion session held at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). Investigators from the Memorial Sloan-Kettering Cancer Center concluded that perifosine was demonstrated to be safe and well tolerated in children with advanced solid tumors and that perifosine may have antitumor clinical activity as a single agent in neuroblastoma.

Additionally, the Nationaly Cancer Institute recently published a preclinical study that found perifosine showed a statistically significant reduction in neuroblastoma cell survival, slowed or regressed tumor growth, and increased survival in mice bearing neuroblastoma tumors.

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.