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Orexigen Therapeutics (Nasdaq: OREX) $4.87. Announced Tuesday after market close along with Takeda Pharmaceutical Company Limited that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 7 that the available data adequately demonstrate that the potential benefits of Contrave (naltrexone sustained release (SR)/bupropion SR) outweigh the potential risks when used long-term in a population of overweight and obese individuals and support approval. The Committee also voted 11 to 8 that a dedicated study to examine the drug's effect on risk for major adverse cardiac events should be conducted as a post-approval requirement versus pre-approval.
"We are encouraged by the panel's view of the risk-benefit profile of Contrave," said Michael Narachi, president and CEO of Orexigen. "We look forward to continued discussions with the FDA regarding the design of a post-marketing study to evaluate cardiovascular risk and to address the questions raised at the meeting today in preparation for our PDUFA action date in January."
The advisory committee's decision is a non-binding recommendation to be considered by the FDA in finalizing the review of the Contrave New Drug Application (NDA). A PDUFA action date of January 31, 2011 has been assigned for the review of the NDA.
What They Do: Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity.
Dynamex Inc. (Nasdaq: DDMX) $24.25. Announced Tuesday after market close that on December 6, 2010, the party that was previously designated as an “excluded party” (“Takeover Party”), as such term is defined in the Agreement and Plan of Merger, dated as of October 1, 2010, by and among the Company, DashNow Holding Corp., a Delaware corporation and an affiliate of Greenbriar Equity Group LLC (“Parent”), and DashNow Acquisition Corp., a Delaware corporation (“Merger Sub”), as amended by Amendment No. 1 to the Agreement and Plan of Merger, dated November 30, 2010, by and among the Company, Parent and Merger Sub (as amended, the “Current Merger Agreement”), submitted a formal binding offer for the acquisition of the Company in which the Company’s stockholders would receive $25.00 per share in cash (the “Takeover Proposal”). The Takeover Proposal included an Agreement and Plan of Merger, which was executed by the Takeover Party and one of its affiliates (the “Proposed Merger Agreement”). The Takeover Proposal expires upon certain events, including the Company’s failure to accept, execute and deliver the Proposed Merger Agreement to the Takeover Party by 11:59 a.m.., New York City time, on December 14, 2010.
On December 7, 2010, the Company’s board of directors determined, in accordance with the terms of the Current Merger Agreement, that the Takeover Proposal constitutes a “superior proposal” as such term is defined in the Current Merger Agreement and that a failure to enter into the Proposed Merger Agreement would violate the directors’ fiduciary duties to the Company’s stockholders under applicable law (the “Determination”). In making this Determination, the Company’s board of directors consulted with its financial advisor and outside legal counsel.
What They Do: Dynamex is the leading provider of same-day delivery and logistics services in the United States and Canada.
TASER International (Nasdaq: TASR) $4.09. Today announced it has received five significant follow-on orders of TASER X26 electronic control devices (ECDs) and related accessories. The first order received was from a U.S. federal agency to provide 692 TASER X26 ECDs with 1384 TASER cartridges.
The other orders were from four separate international customers. These orders include a total of 3110 ADVANCED TASER M26 ECDs; 712 TASER X26 ECDs; 712 TASER CAM units; and 65,000 TASER cartridges. It is anticipated that these orders will ship in the 4th Quarter of 2010.
What They Do: TASER International, Inc. is the global leader in the development of technologies that Protect Life and Protect Truth. More than 15,800 public safety agencies in 40 countries rely on TASER electronic control devices (ECDs) also known in Canada as Conducted Energy Weapons (CEWs) to help protect and serve.
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