• Alexza Pharmaceuticals Inc., of Mountain View, Calif., resubmitted its new drug application for Adasuve to the FDA, sending its shares (NASDAQ:ALXA) up 45 percent Friday. With the $1.23 jump, Alexza closed the week at $3.97. The resubmission was in response to a May complete response letter that cited deficiencies at Alexza's manufacturing facility and draft labeling. As part of the resubmission, Alexza proposed updated labeling for Adasuve (Staccato loxapine) as an acute treatment for agitation associated with schizophrenia or bipolar I disorder in adults. Alexza said it believes it has a substantial agreement with the FDA on the risk evaluation and mitigation strategy required for the drug. Adasuve is partnered with Grupo Ferrer Internacional SA, of Barcelona, Spain, in Europe, Latin America, Russia and the Commonwealth of Independent States countries. (See BioWorld Today, Dec. 9, 2011, and May 7, 2012.)

• Depomed Inc., of Menlo Park, Calif., said it acquired all rights to Zipsor (diclofenac potassium), a nonsteroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain, from Xanodyne Pharmaceuticals Inc., of Newport, Ky. Zipsor posted sales of about $19 million for the 12 months ended May 31 . Under the terms, Depomed acquired the product in exchange for $25.9 million in cash and potential milestones based on sales of Zipsor and assumption of certain liabilities. Shares of Depomed (NASDAQ:DEPO) gained 57 cents, or 11 percent, to close Friday at $5.71 .

• OxiGene Inc., of South San Francisco, said it signed an exclusive, worldwide licensing deal with Angiogene Pharmaceuticals Ltd., of Oxford, UK, for data, development plans, know-how, patents and other intellectual property rights relative to its vascular-disrupting agent program for neuroendocrine cancers, focused specifically on carcinoid syndrome. OxiGene plans to leverage those assets for the development and potential commercialization of Zybrestat in carcinoid syndrome associated with metastatic carcinoid and neuroendocrine tumors. Terms of the deal were not disclosed.

• Repligen Corp., of Waltham, Mass., received a complete response letter from the FDA on its new drug application for pancreatic imaging agent RG1068 (synthetic human secretin). The letter was not unexpected, as the agency canceled an advisory committee meeting for the drug a few months ago. While the FDA cited no specific safety concerns, it asked for additional clinical efficacy and safety trial data. Shares of Repligen (NASDAQ:RGEN) closed at $3.95 Friday, down 43 cents, or 9.8 percent. (See BioWorld Today, April 27, 2012.)

• Spectrum Pharmaceuticals Inc., of Henderson, Nev., extended its tender offer, for the third time, to purchase outstanding shares of Allos Therapeutics Inc., of Westminster, Colo. The offer – $1.82 per share in cash, plus one contingent value right, which entitles Allos stockholders to an additional payment of 11 cents per share if certain European regulatory approval and commercialization milestones for Folotyn are achieved – was originally set to expire last week. It has been extended through July 9 due to the FTC's request for additional information. As of Thursday, more than 61 .6 million Allos shares, or about 57.6 percent of its outstanding shares, had been tendered. (See BioWorld Today, April 6, 2012.)

• Theratechnologies Inc., of Montreal, said partner Grupo Ferrer Internacional SA, of Barcelona, Spain, is withdrawing the marketing authorization application in Europe for tesamorelin for treating excess abdominal fat in HIV-infected patients with lipodystrophy. Ferrer said the decision followed an oral explanation with the European Committee for Medicinal Products for Human Use citing the lack of data on cardiovascular risk markers. In other news, Theratechnologies said it received a notice of noncompliance regarding its drug submission for tesamorelin in Canada. The letter raised questions regarding the long-term safety of the drug, the appropriate patient population and the proposed indication. The firm and its partner in that territory, Actelion Pharmaceuticals Canada Inc., of Laval, Quebec, have 90 days to answer the questions, and Theratechnologies now expects to receive Health Canada's final decision in the first half of 2013. The company also noted regulatory trouble in Brazil, where partner Paris-based Sanofi SA said regulators had identified technical deficiencies with the Montreal-based third-party manufacturing site for tesamorelin, which might delay Brazil's regulatory decision. Shares of Theratechnologies (TSX:TH) plunged C$1.17 (US$1.22), or 61.6 percent, to close Friday at C73 cents.