• CommonMind Consortium (CMC), launched in April 2012, said its membership has expanded to include five academic groups: Icahn School of Medicine at Mount Sinai; University of Pennsylvania; National Institute of Mental Health; University of Pittsburgh; and University of Texas Southwestern – UTSW, along with two pharmaceutical firms, Takeda Pharmaceuticals Co. Ltd., of Osaka, Japan, and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, plus one nonprofit group, Sage Bionetworks. CMC is a public-private, pre-competitive consortium that brings together disease area expertise, large-scale and well-curated brain sample collections, and data management and analysis expertise with a goal to generate and analyze large-scale genomic data from human subjects with neuropsychiatric disease and to make the data and the associated analytical results broadly available to the public

• DARA BioSciences Inc., of Raleigh, N.C., was notified by Nasdaq that the company regained compliance with Rule 5550(a)(2), which requires a minimum bid price of $1 for continued listing.

• GTx Inc., of Memphis, Tenn., said new data from two Phase II studies on the effects of Capesaris (GTx-758), a selective estrogen receptor alpha agonist for the treatment of advanced prostate cancer, will be detailed in presentations Feb. 14-15, at the ASCO Genitourinary Cancer Symposium in Orlando, Fla. The studies showed improvements in bone turnover and lowering testosterone.

• Helmedix Pty Ltd., was launched with start-up financing from Australia's Medical Research Commercialization Fund (MCRF). Based on intellectual property from the University of Technology Sydney, Helmedix will develop therapeutic peptide drugs for the prevention and treatment of autoimmune disease. The MRCF has committed A$1 .25 million (US$1.29 million) to progress lead optimization and preclinical development of the immune modulating peptides over the next two years.

• Oramed Pharmaceuticals Inc., of Jerusalem, said the FDA responded to its investigational new drug (IND) application for oral insulin, requesting a sub study in a controlled inpatient setting. The company said it will submit a new IND containing a clinical protocol for the sub study.

• OSE Pharma SA, of Paris, said the FDA granted orphan drug status to its lead candidate, OSE 2101, to treat non-small-cell lung cancer (NSCLC) in patients expressing HLA-A2. The targeted cancer immunotherapy, in Phase III studies, is composed of 10 synthetic peptides that target five tumor-associated antigens. HLA A2-positive patients represent 45 percent of the NSCLC population, OSE said.

• Santarus Inc., of San Diego, launched Uceris (budesonide) extended-release tablets in the U.S. for the treatment of active, mild-to-moderate ulcerative colitis. The drug contains budesonide, a locally acting glucocorticosteroid, in an oral tablet formulation that uses MMX colonic delivery technology. Santarus said it added 85 sales representatives for the commercial launch, increasing its sales force to 235. Developed in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals SpA, of Lainate, Italy, Uceris was approved by the FDA in January. Upon the commencement of commercial sales, $7 million is payable to Cosmo in cash or Santarus common stock, at Cosmo's option. (See BioWorld Today, Jan. 16, 2013.)

• United Therapeutics Corp., of Silver Spring, Md., said the FDA acknowledged the resubmission of its new drug application (NDA) for treprostinil diolamine (oral treprostinil) in pulmonary arterial hypertension. The FDA classified the resubmission as a complete, Class 1 response to its October 2012 complete response letter and set a PDUFA date of March 31. ISI Group analyst Mark Schoenebaum noted that "the company likely submitted new analyses of existing data," since United "disagreed with several of the FDA's original arguments/criticisms, and we suspect a good part of the re-submission outlines UTHR's contra-arguments in detail." He pegged the odds of FDA approval at less than 50 percent, but added "there is now the opportunity for a major upside surprise that did not exist previously." Deutsche Bank analyst Robyn Karnauskas wrote in a company alert that "We do not believe investors will assign much value to oral remodulin just yet given the weak data from Phase III studies." Only one of two Phase III studies met the primary endpoint, which could limit the drug's commercial potential, she added. On Thursday, United's shares (NASDAQ:UTHR) gained $2.29, to close at $56.10.

• Verastem Inc., of Cambridge, Mass., filed for orphan drug designation for VS-6063 in the U.S. and European Union in mesothelioma. The oral small-molecule inhibitor of focal adhesion kinase, a critical pathway for cancer stem cells, is expected to enter a potentially pivotal study in mesothelioma in mid-2013.