Posts Tagged ‘therapeutics’

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.

TorreyPines Therapeutics, Inc. (TPTX) Buzz Stock of the Day

Wednesday, August 26th, 2009

Shares of TorreyPines Therapeutics, Inc.(NASDAQ: TPTX) skyrocketed more than 261 percent in morning trading after proposed merger candidate, Raptor Pharmaceuticals, Inc. (OTCBB: RPTP) announced it raised $5 million through a private placement offering. A portion of the proceeds would be used to close a merger with TorreyPines, which was announced in late July.

Raptor raised $2.6 million in a private placement and another $2.4 million in a warrant exchange. The company sold 7.5 million units (each a share of stock and a warrant to buy another half share). It also raised about $2.4 million by exchanging warrants from a previous private placement in 2008 for new warrants. Proceeds will also be used to fund late-stage drug development and commercialization.

Under terms of the agreement, Raptor will be merged with and into a wholly owned subsidiary of TorreyPines, and TorreyPines will issue its common stock to Raptor stockholders. TorreyPines stockholders will own about 5 percent in the combined company, which will be named Raptor Pharmaceuticals, the companies said. The merger is expected to complete in the fourth quarter of 2009, dependent on the review process by regulatory agencies.

Additionally, TorreyPines will implement a reverse stock split to ensure compliance with Nasdaq listing requirements, and the size of the split will be determined at closing.

Raptor CEO, Christopher Starr will be the CEO of the combined company. TorreyPines CEO Evelyn Graham, CFO Craig Johnson, and Vice President Paul Schneider will remain with the combined company under new employment contracts that expire in 2010. TorreyPines directors have agreed to quit when the deal is closed.

TorreyPines’ products under development include Tezampanel, which completed Phase II clinical trial for the treatment of migraine; and NGX426, which completed Phase I clinical trial for the treatment of migraine and neuropathic pain. It also develops NGX267, a Phase II clinical trial product for the treatment of Xerostomia; and a Gamma-secretase modulator drug discovery program as a treatment for Alzheimer s disease. The company has a strategic alliance and licensing agreements with Eisai Co., Ltd.; Eli Lilly and Company; Life Science Research Israel, Ltd.; and University of Iowa Research Foundation.

Anika Therapeutics Inc. (ANIK) Buzz Stock of the Day

Wednesday, August 19th, 2009

Shares of Anika Therapeutics, Inc. (NASDAQ: ANIK) rose nearly 74 percent on Thursday after the drug maker received approval from Health Canada for its osteoarthritis of the knee treatment, MONOVISC™. The product will be distributed in Canada by Anika’s distribution partner, Helix BioPharma Corp.

“Health Canada approval marks an important next step as we continue to expand the geographic reach of our novel osteoarthritis treatment therapy and establish MONOVISC as the premier single-injection product on the market worldwide,” said Charles H. Sherwood, Ph.D., Anika’s President and Chief Executive Officer in a statement.

The single injection viscosupplement drug has been available in the European Union since early 2008 and is currently being evaluated by the U.S. Food and Drug Administration.

The company has steadily made progress toward U.S. approval of the knee drug, and is expected to submit additional clinical data to the FDA before the end of the year. The company filed a modular premarket approval (PMA) application with the FDA for MONOVISC, which allows for submission of clinical data on an ongoing basis rather than all at once. Anika had previously presented an initial module of trial data for MONOVISC™.

MONOVISC™ is currently undergoing a retreatment study, which focuses on the safety of the drug and the benefits of repeat injections.

Anika also received a boost on Thursday as news broke that a U.S. advisory panel recommended that regulators reject a similar injection treatment for knee pain submitted by rival companies Q-Med AB and Smith & Nephew.

The panel decision could have long-term advantages for Anika if MONOVISC™ gets FDA approval. The drug would be the second single injection product on the market with the other being Genzyme Corporation’s drug, Synvisc-One™.