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An announcement from Island Pharmaceuticals Ltd ( (AU:ILA) ) is now available.
Island Pharmaceuticals Ltd announced that the US FDA has agreed to the Animal Rule pathway for the development of Galidesivir as a countermeasure against the Marburg virus. This pathway, along with the potential eligibility for a Priority Review Voucher, significantly de-risks and accelerates the regulatory process for the drug. The FDA’s guidance on the clinical program design will enable Island Pharmaceuticals to finalize its plans for trial commencement in early 2026. The positive feedback from the FDA underscores the strength of Galidesivir’s historical data, which showed a 94% survival rate in Marburg-infected primates. The company is advancing agreements with potential trial sites and engaging with the US government to further its strategy of including Galidesivir in national stockpiles, which could create substantial strategic and financial value for stakeholders.
More about Island Pharmaceuticals Ltd
Island Pharmaceuticals Ltd is an Australian antiviral drug development company focused on creating countermeasures against high-priority viral threats. The company is primarily involved in the development of drugs like Galidesivir, which is intended for use against viruses such as Marburg. Island Pharmaceuticals aims to position its products for inclusion in government stockpiles, enhancing its market focus on critical viral threats.
Average Trading Volume: 623,268
Technical Sentiment Signal: Buy
Current Market Cap: A$108.2M
See more data about ILA stock on TipRanks’ Stock Analysis page.