• AEterna Zentaris Inc., of Quebec City, said it was notified by Nasdaq that it has regained compliance with the listing rule relating to the maintenance of a minimum bid price and will continue to be listed on the exchange.

• Antigenics Inc., of New York, said Oncophage (vitespen) received orphan drug designation from the FDA for glioma. The cancer vaccine received European orphan drug designation for glioma last month, and a Phase II glioma trial is ongoing. Oncophage is approved in Russia for adjuvant treatment of kidney cancer and also is under review in Europe for kidney cancer, although its Phase III kidney cancer trial failed.

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said Toctino (alitretinoin), a once-daily, oral treatment for severe chronic hand eczema, was approved by the Dutch Medicines Evaluation Board. The drug has been approved in several European countries and is under review in several others. A Phase III trial is under way in the U.S.

• Ceragenix Pharmaceuticals Inc., of Denver, Colo., has entered an agreement with MAST BioSurgery Inc., of San Diego, to develop one or more new surgical products incorporating Ceragenix's CeraShield antimicrobial technology. Under the terms of the deal, MAST will have exclusive rights to develop specified products and negotiate commercialization terms for those products for six months.

• Clinical Genomics Pty Ltd., of Sydney, Australia, said Madison, N.J.-based Quest Diagnostics Inc. agreed to provide milestone payments over the next two years to further develop Clinical Genomics' portfolio of gene-based biomarkers associated with the early onset of colorectal cancer. Under the terms, Quest has exclusive rights to the biomarkers for use in developing a test as an aid in detecting precancerous and cancerous colorectal tumors in conjunction with other clinical findings. Additional financial terms were not disclosed.

• DeCode Genetics Inc., of Reykjavik, Iceland, said it received a letter from Nasdaq calling for review the April 22 determination of the listing qualifications panel regarding the delisting of the company's common stock. Pending the completion of that review, the Nasdaq Listing and Hearing Review Council has stayed the panel's proposed suspension of trading. The stock will continue trading as usual during the review process.

• Dendreon Corp., of Seattle, saw its shares (NASDAQ:DNDN) pop $11.13, or 94 percent, to close at $22.94 on Wednesday. The company reported late Tuesday that prostate cancer vaccine Provenge (sipuleucel-T) reduced the risk of death by 22.5 percent (p = 0.032; HR = 0.775) and extended median survival by 4.1 months compared to placebo in its confirmatory Phase III IMPACT trial. (See BioWorld Today, April 29, 2009.)

• GeneNews Ltd., of Toronto, said it will receive a grant of MYR5 million (US$1.39 million) from the Malaysian Ministry of Health to develop blood-based diagnostic tests for liver cancer, Hepatitis B and nasopharyngeal cancer. Shares of GeneNews (TSX:GEN) rose C5 cents to close at C37 cents on Wednesday.

• ImQuest BioSciences and Arisyn Therapeutics, both of Frederick, Md., have entered into a drug development partnership to provide support to develop Arisyn's portfolio of inhibitors for the treatment of infectious disease and cancer. Arisyn recently acquired a series of inhibitors that demonstrated preclinical efficacy against HIV, HCV, HTLV-I, influenza virus, herpes viruses and cancer. ImQuest will provide support to begin clinical trials with lead products ATI-0312 for HIV and ATI-0810 for HCV and will initiate mechanistic studies to define the unique virus transcription inhibitory mechanism of action of the class of inhibitors.

• Kinaxo Biotechnologies GmbH, of Martinsried, Germany, has applied its cellular target profiling technology to identify the protein kinase mTOR as a new cellular target of celecoxib (sold as Celebrex by Pfizer Inc.). The discovery that celecoxib targets mTOR (mammalian target of rapamycin) contributes to a better understanding of the drug's mode of action and efficacy in cancer patients, the company said.

• United Therapeutics Corp., of Silver Spring, Md., said the FDA extended the PDUFA date for its pulmonary arterial hypertension drug Tyvaso (inhaled treprostinil) to July 30. The original date was April 30, but the company said last month that a delay was likely due to the agency's concerns about the instructions for the nebulizer that delivers Tyvaso as well as the FDA's request for an additional small human factors testing study. The data from that study were submitted earlier this month.