Posts Tagged ‘pharmaceutical stocks’

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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.

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Acorda Therapeutics, Inc. (Nasdaq: ACOR) Buzz Stock of the Day

Thursday, October 15th, 2009

Shares of Acorda Therapeutics, Inc. (Nasdaq: ACOR) skyrocketed 50 percent in morning trading Thursday to a high of $26 from Wednesday’s closing price of $16.74 after analysts said a U.S. Food and Drug Administration (FDA) panel review of the company’s multiple sclerosis drug paved the way for approval by next year. Acorda Therapeutics Inc. topped the list of Biggest Percentage Price Gainers among common stocks on the Nasdaq Stock Market.

An Advisory Committee panel announced today that they would stand behind Acorda’s drug candidate Fampridine-SR, a multiple sclerosis drug geared to help mobility in patients. The announcement today came in sharp contrast to a more negative review by FDA staff a few days earlier that sent the company’s shares down sharply, analysts said.

“In my view, the briefing documents were a total red herring to investors, most of whom sold positions heavily,” said Hapoalim Securities analyst Raghuram Selvaraju. “This morning, what you’re seeing is the about-face that I would have expected.”

The FDA will decide on October 22 whether the drug will be approved. An unaffiliated panel of experts voted 12-1 in favor of the drug, and concluded that fampridine was both safe and effective, but recommended it not be used in patients with known seizure problems. Additionally, the experts recommended lower doses be studied in clinical trials, which could be done after FDA approval. Some analysts predicted approval could be delayed until early 2010 to prepare a program to manage fampridine’s risks.

Ron Cohen, M.D., Acorda Therapeutics President and CEO said in a statement Thursday, “We are pleased with the outcome of today’s Advisory Committee meeting. People with MS have an urgent need for therapies to improve their walking, which is essential to conducting their activities of daily life. If approved, Fampridine-SR would be the first medicine to improve walking in people with MS.”

Analyst Raghuram Selvaraju projects annual sales of fampridine reaching $900 million by 2017, putting it near the $1 billion threshold for a drug to be deemed a blockbuster. The 50 percent surge in share prices Thursday launched Acorda Therapeutics to a market value of nearly $1 billion, which combined with the earnings potential of fampridine, makes Acorda a possible acquisition candidate.

Aside from Biogen Idec (BIIB.O), which holds fampridine rights outside the United States, analysts predict other pharmaceutical companies with multiple sclerosis programs might be interested in acquiring Acorda, including: Teva Pharmaceutical Industries (TEVA.TA), Novartis (NOVN.VX), Merck KGaA (MRCG.DE) and Sanofi Aventis (SASY.PA), which is developing a drug that is similar to fampridine, but further behind in development.

Selvaraju continues, “I think they’re an extremely eminent takeover target, I think any company that either has a foothold in the MS space or wants to have one should be very interested in this company.”

Acorda Therapeutics does not comment on speculation regarding possible acquisitions.

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Opexa Therapeutics Inc (OPXA) Buzz Stock of the Day

Tuesday, September 8th, 2009

Shares of Opexa Therapeutics, Inc.(NASDAQ: OPXA) were up more than 150 percent from Friday’s close in morning trading on Tuesday, after the company announced that more than 83 percent of patients taking its experimental multiple sclerosis drug, Tovaxin, remained relapse-free after one-year.


In addition, the annualized relapse rate among patients who took Tovaxin fell to 20 percent, a 42 percent reduction compared with the placebo. Tovaxin also showed stabilization and improvement of MS-related disabilities in 73 percent of patients, 16.5 percent of which showed sustained improvement of a least one full point on a standard disability scale.

The data was based on a 52-week Phase IIb clinical study that targeted 150 patients with relapsing, remitting multiple sclerosis, typically the initial stage of the disease. Patients in this stage of multiple sclerosis often experience unpredictable relapses, often followed by months or years of dormancy.

“Clinical benefits include not only reduction in relapses, but a surprising reversal of disability in over 16 percent of Tovaxin-treated patients,” said Dawn McGuire, MD, a board certified neurologist and a member of Opexa’s Clinical Advisory Board.

Opexa said it plans to recruit similar patients for another Phase IIb study of Tovaxin, which is a vaccine tailored to individual patients. The drug helps limit attacks by immune system cells called T-cells on myelin, the protein sheath that protects nerves.

Opexa’s news today carried the Stem Cell Stock Index 9.3 percent higher today. The Index, which is compilation of companies using stem cells to develop treatments, is currently ahead of the S&P 500 by 2.7% over the last month.

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The Medicines Co. (MDCO)– Buzz Stock of the Day

Wednesday, September 2nd, 2009

Shares of The Medicines Co.(NASDAQ: MDCO) was up as much 35 percent on Wednesday morning after the company announced the issuance of a new patent for a safer version of Angiomax, the Company’s anti-clotting drug for patients undergoing coronary angioplasty.

The newly issued patent, No. 7,582,727 (‘727 patent) updates the current patent covering Angiomax, after the company preformed further clinical studies to improve the drug. The ‘727 refers to an improved and safer version of Angiomax.

The new patent has been presented to the U.S. Food and Drug Administration (FDA) for immediate listing in the FDA’s publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” generally referred to as the Orange Book. The drug’s current U.S. patent No. 5,196,404 (‘404 patent), expires on March 23, 2010 and specifically relates to the composition of the chemical bivalirudin. Furthermore, The Medicines Company has been granted pediatric exclusivity through September 23, 2010.

In clinical trials, Angiomax showed absolute reduction of 1.7 percent in cardiac mortality and improved overall survival in patients who had suffered the most severe heart attack and received angioplasty. The study, which is called the Horizons-AMI, showed that Angiomax reduced cardiac-related death by 43 percent, improved overall survival by 27 percent and reduced major bleeding complications by 39 percent, compared to the standard of care.

“These results underscore our goal: to bring to doctors critical care medicines that change clinical practice for the better,” said the Company’s President and Chief Operating Officer, John Kelley.

The data also supports results from previous studies that showed an association between reduced major bleeding in angioplasty patients and greater long-term survival.

“The bottom line is that in this population of heart attack patients undergoing PCI, Angiomax saves lives, and the degree of that benefit is striking,” said Kelley.

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Trubion Pharmaceuticals, Inc. (TRBN) – Buzz Stock of the Day

Friday, August 28th, 2009

Shares of Trubion Pharmaceuticals, Inc.(NASDAQ: TRBN) were up as much as 76 percent in morning trading on Friday, after the company announced a drug development deal for its leukemia drug with Facet Biotech Corp.(NASDAQ: FACT) .

“In considering alliance opportunities for TRU-016 we sought to retain meaningful economics in this exciting first-in-class product candidate, while enabling aggressive joint development with a partner who shared our vision and brought complementary experience and resources to the alliance,” said Trubion’s Chairman and CEO, Dr. Peter Thompson.

Trubion will receive $20 million upfront from Facet, with the potential for an additional $176.5 million based on certain developmental, regulatory and commercialization milestones. Additionally, Facet will purchase 2.2 million newly-issued shares of Trubion common stock, worth approximately $10 million.

TRU-016 is currently in clinical development for the treatment of B-cell malignancies, otherwise known as chronic lymphocytic leukemia (CLL, and is a CD37-directed Small Modular ImmunoPharmaceutical (SMIP™) protein therapeutic. TRU-016 uses a different active mechanism than CD20-directed treatments, and as a result, may provide cancer patients enhanced therapeutic options and improved effectiveness when used alone or with chemotherapy and/or CD20-based therapeutics. The drug could also have the potential to treat other cancers that affect the immune system’s B-cells, along with autoimmune and inflammatory diseases.

In June 2009, positive results following preliminary analysis from the Phase 1 clinical trial of TRU-016 for the treatment of CLL were announced. The objectives of the Phase 1 TRU-016 CLL study were to define safety and tolerability, identify a maximum tolerated dose, evaluate pharmacology and pharmacodynamics, and assess preliminary clinical activity.

“(The Trubion drug) is a promising therapeutic with impressive preclinical and preliminary clinical data for CLL that will greatly enhance our pipeline and support a key strategic objective, which is to build a robust oncology portfolio,” said Faheem Hasnain, president and CEO of Facet Biotech, in a statement.
Both companies will share costs associated with developing, selling and marketing the drug. The deal also states that Facet and Trubion will share worldwide rights to the drug as well as rights to other, similar CD37-directed protein therapeutic drugs in Trubion’s pipeline.

“We are delighted to have Facet as our partner,” Dr. Thompson said. “Coupled with our own strengths in the discovery and development of novel protein therapeutics, their expertise will afford us the opportunity to pursue the clinical development and commercialization of TRU-016 and other CD37-directed therapeutics in the most aggressive manner possible.”

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