Island Pharmaceuticals (ASX:ILA) said the US Food and Drug Administration (FDA) needs additional time to respond to its recent submission on the clinical development of galidesivir under the animal rule, according to a Monday Australian bourse filing.
Galidesivir is a clinical-stage molecule being developed for use against various viruses, including Ebola and yellow fever.
The US FDA has not raised any concerns or requested additional information, and the company continues to engage in constructive dialogue, per the filing.
The company is advancing preparatory work, including organizing a non-human primate study and coordinating with US government stakeholders, and is prepared to implement FDA guidance and move forward with study initiation once approval is granted, the filing added.
The company's shares rose 2% in recent Monday trade.