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Daily Dose: TZYM Plunges, GALE Announces Offering, GSK, QDEL Receive Clearance


Shares of Tranzyme Inc. (TZYM) plunged 19 percent to close Monday's trading at $0.59 after the company halted its second phase IIb trial of TZP-102, dubbed DIGEST, for diabetic gastroparesis, due to insufficient efficacy.

Last month, the first phase IIb trial of TZP-102 in diabetic patients with gastroparesis also failed to meet its primary efficacy endpoint, sending the shares down by 75%. Since November of this year, the shares have lost nearly 86% of their value.

Shares of Galena Biopharma Inc. (GALE) were down nearly 23 percent in after-hours trading Monday following the company's announcement of a public offering of its common stock and warrants.

The company's lead product candidate is NeuVax, which is under phase III testing, to prevent recurrence of breast cancer. The company intends to use the net proceeds from the offering to conduct its ongoing phase III clinical trial for NeuVax, its phase 1/2 trial of Folate Binding Peptide vaccine, E39, in ovarian cancer and endometrial adenocarcinomas, the planned phase II clinical trial for NeuVax in combination with Herceptin, as well as for general corporate purposes.

The actual size or terms of the offering were not revealed.

Quidel Corp. (QDEL) announced it has received FDA clearance for its AmpliVue hand-held molecular diagnostic test for Clostridium Difficile. The AmpliVue received CE mark in Europe in March of this year and has been available there since then.

GlaxoSmithKline plc's (GSK) Fluarix Quadrivalent, the first intramuscular vaccine to cover against four influenza strains, has been approved by FDA for the immunisation of children (three years and older) and adults in the U.S.

Fluarix Quadrivalent is expected to be made available in time for the 2013-14 flu season.

Paladin Labs Inc. (PLB.TO) and Somaxon Pharmaceuticals Inc. (SOMX) announced that the drug Silenor has been approved in Canada for the treatment and symptomatic relief of insomnia.

Paladin received rights to commercialize Silenor in Canada, South America and Africa from Somaxon in June 2011. The drug is expected to be launched in the Canadian market in mid-2013.

Upon commercialization of Silenor in the licensed territories, Somaxon will be eligible to receive sales-based milestone payments of up to US$128.5 million as well as a tiered double-digit percentage of net sales.

Somaxon maintains the rights to Silenor in the U.S., Europe and Japan. The drug was approved by the FDA in 2010. Last week, Somaxon announced that it has agreed to be acquired by Pernix Therapeutics Holdings Inc. (PTX) in a stock-for-stock transaction valued at $25 million.

Canadian biotechnology company Algae Biosciences Corp. (ABV.V) witnessed an unusually active trading activity on Monday with its shares falling more than 8 percent on a volume - 64 times its 3-month average volume. AlgaeBio said that there is no new reason for the unusual activity and that all material events concerning the company have been fully disclosed in previous press releases and other required filings.

Antares Pharma Inc. (ATRS) announced that it has submitted the New Drug Application for Otrexup for the treatment of rheumatoid arthritis and psoriasis. Otrexup, a combination product, which uses Medi-Jet technology, is designed for convenient subcutaneous delivery of Methotrexate in patients with rheumatoid arthritis or psoriasis. Methotrexate is the most commonly used disease-modifying anti-rheumatic drug, or DMARD.

Cyclacel Pharmaceuticals Inc. (CYCC) announced that it has entered into a $20 million common stock purchase agreement with Aspire Capital Fund LLC. According to the company, on December 13, Aspire invested $1 million in Cyclacel common stock at a per share price equal to that day's closing price of $6.29. Aspire will be purchasing Cyclacel's common stock from time to time as directed by Cyclacel over the next two years at prices based on the market price at the time of each sale.

Lexicon Pharmaceuticals Inc. (LXRX) rose 6% to close Monday's trading at $1.98 after the company's drug candidate for irritable bowel syndrome - LX1033, was bestowed fast track status by the FDA.

LX1033 is currently under a phase II trial in approximately 360 diarrhea-predominant irritable bowel syndrome (IBS-d) patients, with results expected in the first half of 2013.

by RTTNews Staff Writer

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