Cornerstone Therapeutics reported Thursday that the Food and Drug Administration wants more data before considering approval of the company's experimental treatment for hyponatremia, a condition associated with heart failure.
The FDA's request for additional clinical and non-clinical information came as no surprise given that an agency advisory committee recommended against approving the drug, lixivaptan, in September.
CEO Craig Collard said in a statement that the company is reviewing the FDA's response before determining its next step.
"We believe we have strong clinical data supporting lixivaptan for the treatment of hyponatremia and that a significant unmet need remains," he said.
Cornerstone shares rose 12 cents on Thursday, closing at $5.01. Its shares have fallen 11 percent this year.