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Island Pharmaceuticals Ltd ( (AU:ILA) ) has shared an update.
Island Pharmaceuticals Ltd has announced that the US Food & Drug Administration (FDA) has granted a Type C meeting request under Galidesivir’s open Investigational New Drug (IND) application. This meeting will allow the company to align with the FDA on utilizing the Animal Rule to fast-track Galidesivir’s approval for use against the Marburg virus. The FDA will provide written feedback by November 12, 2025, and Island will submit a comprehensive briefing package with historical data. This development is a significant milestone for Island Pharmaceuticals as it seeks to become a trusted provider for government stockpiles by supplying solutions for high-priority public health threats.
More about Island Pharmaceuticals Ltd
Island Pharmaceuticals Ltd is an Australian antiviral drug development company focused on addressing urgent viral diseases, public health, and biosecurity threats. The company is executing a dual development strategy for its assets, ISLA-101 and Galidesivir. ISLA-101 is being repurposed for the prevention and treatment of dengue fever and other vector-borne diseases, while Galidesivir is a clinical-stage antiviral molecule with broad-spectrum activity against over 20 RNA viruses, including high-priority threats like Ebola, Marburg, MERS, Zika, and Yellow fever.
Average Trading Volume: 632,564
Technical Sentiment Signal: Buy
Current Market Cap: A$90.09M
For an in-depth examination of ILA stock, go to TipRanks’ Overview page.