Shares of Cadence Pharmaceuticals (CADX) surged this morning after the developer said that it plans to resubmit its marketing application for the pain therapy Ofirmev within 30 days. Citing problems with a third-party manufacturer, the FDA denied approval back in February.
The FDA did not ask for any new data or stability studies, and Cadence says that after a meeting with regulators on Friday the biotech plans to continue to work with the manufacturer. Cadence shares jumped 13 percent on the news about Ofirmev, an intravenous formulation of acetaminophen.
"We believe that last week's meeting with FDA was an important step forward to address the observations from the FDA's inspection of our third party manufacturer's facility and move toward potential approval of Ofirmev," said CEO Ted Schroeder. "Based upon our discussions with the agency, we believe that it is appropriate to promptly resubmit the NDA for Ofirmev and intend do so within the next 30 days."
- here's Cadence's release
- and here's the story from Reuters