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Island Pharmaceuticals Ltd ( (AU:ILA) ) has shared an announcement.
Island Pharmaceuticals Ltd has submitted a comprehensive briefing document to the US Food & Drug Administration (FDA) for a Type C meeting to advance the approval pathway of its antiviral drug, Galidesivir. The submission aims to align with the FDA on using the Animal Rule for Galidesivir’s clinical development and approval, with written responses expected by November 12, 2025. This step is crucial for the company’s regulatory strategy and involves finalizing negotiations with a strategic counterparty for a planned animal study in Marburg, which is expected to be completed by the fourth quarter of 2025.
More about Island Pharmaceuticals Ltd
Island Pharmaceuticals Ltd is an Australian antiviral drug development company focused on addressing urgent viral diseases, public health, or biosecurity threats. The company is executing a dual development strategy for its assets, ISLA-101 and Galidesivir. ISLA-101 is repurposed for the prevention and treatment of dengue fever and other mosquito-borne diseases, while Galidesivir is a clinical-stage antiviral molecule with broad-spectrum activity against over 20 RNA viruses, including high-priority threats such as Ebola, Marburg, MERS, Zika, and Yellow fever.
Average Trading Volume: 754,577
Technical Sentiment Signal: Buy
Current Market Cap: A$104M
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