Key Developments For Cadence Pharmaceuticals, Inc.
Cadence Pharmaceuticals, Inc. (CADX.O) (Consolidated Issue listed on NASDAQ Global Market)
Cadence Pharmaceuticals, Inc. Announces FDA Extends New Drug Application Review For Intravenous Acetaminophen By Three Months
Cadence Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the New Drug Application (NDA) for intravenous (IV) acetaminophen by three months. The extended PDUFA goal date is February 12, 2010. The FDA designated one of Cadence's submissions to the NDA, which contained additional clinical pharmacology data requested by the agency during the review process, as a major amendment. The FDA has the option to extend the PDUFA goal date when a sponsor submits a major amendment to an NDA within three months of the PDUFA goal date to provide time to complete the review. The FDA is not requesting any other information at this time.
Cadence Pharmaceuticals, Inc. Announces Priority Review And Acceptance of NDA Submission For Acetavance
Cadence Pharmaceuticals, Inc. announced that its New Drug Application (NDA) for Acetavance (intravenous acetaminophen), its investigational product candidate for the treatment of acute pain and fever in adults and children, has been accepted for filing by the U.S. Food and Drug Administration (FDA) and designated for Priority Review. Priority Review is granted to those products that address significant unmet medical needs or have the potential to provide a improvement compared to marketed products and provides for a review period of six months from the date of NDA submission. The FDA has issued an action date for the NDA of November 13, 2009 under the Prescription Drug User Fee Act (PDUFA).
Cadence Pharmaceuticals, Inc. Submits Acetavance New Drug Application For Treatment Of Acute Pain And Fever
Cadence Pharmaceuticals, Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational product candidate, Acetavance (intravenous acetaminophen), for the treatment of acute pain and fever in adults and children.
Cadence Pharmaceuticals, Inc. To Stop Development Of Catheter Infection Drug-Reuters
Reuters reported that Cadence Pharmaceuticals, Inc. said it would stop the development of its drug for the prevention of catheter-related infections, after it failed to meet the primary goal of a late-stage trial. Cadence said the main goal of the study was to demonstrate the superiority of its topical gel, Omigard, compared to povidone-iodine for the prevention of local catheter-site infections.
Cadence Pharmaceuticals, Inc. Completes $86.6 Million Private Placement of Common Stock
Cadence Pharmaceuticals, Inc. announced that it completed its previously announced private placement of approximately 12 million shares of the Company's common stock at a price of $7.13 per share and five-year warrants to purchase up to approximately 6 million additional shares of the Company's common stock, exercisable in cash or by net exercise at a price of $7.84 per share, for aggregate gross proceeds of approximately $86.6 million. The price paid for the common stock is equal to the consolidated closing bid price on the Nasdaq Global Market on the day of pricing, February 13, 2009.
