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Island Pharmaceuticals Ltd ( (AU:ILA) ) has issued an announcement.
Island Pharmaceuticals Ltd announced that the US FDA has confirmed the timeline for providing feedback on the clinical development and approval pathway for Galidesivir, an antiviral drug. Despite recent US Government shutdowns, the FDA aims to deliver responses by 12 November 2025, which will include alignment on the use of the Animal Rule to expedite Galidesivir’s approval in Marburg, study design clarification, and potential for a Priority Review Voucher. This development underscores the importance of Galidesivir in public health and the company’s strong communication with the FDA, as it continues negotiations for an animal study in Marburg.
More about Island Pharmaceuticals Ltd
Island Pharmaceuticals Ltd is an Australian antiviral drug development company focusing on addressing urgent viral diseases, public health, or biosecurity threats. The company is developing two main assets: ISLA-101, for the prevention and treatment of dengue fever and other mosquito-borne diseases, and Galidesivir, a clinical-stage antiviral molecule targeting over 20 RNA viruses, including high-priority threats like Ebola, Marburg, MERS, Zika, and Yellow fever.
Average Trading Volume: 661,645
Technical Sentiment Signal: Buy
Current Market Cap: A$90.15M
Learn more about ILA stock on TipRanks’ Stock Analysis page.