Island Pharmaceuticals Limited-FDA Alignment Accelerates Galidesivir Pathway
Island Pharmaceuticals Limited (ASX: ILA) has received highly constructive guidance from the US Food and Drug Administration, confirming the development pathway for Galidesivir under the FDA’s Animal Rule and materially reducing regulatory uncertainty. The FDA has validated Island’s proposed animal model, including the use of the Angola strain of Marburg virus, the cynomolgus macaque model and the challenge dose, establishing the core foundations required for approval. Importantly, a clearly defined two-stage development sequence has been outlined, allowing the program to progress through targeted dose optimisation and pharmacokinetic studies before entering a pivotal confirmatory phase.
Island is positioned to commence these studies immediately using its first manufactured batch of Galidesivir, with engagement well advanced with Texas Biomedical Research Institute and additional partners to accelerate timelines. Approval under the Animal Rule may unlock US Government procurement opportunities, including potential inclusion in the Strategic National Stockpile. In addition, successful approval would entitle Island to a Priority Review Voucher, a significant non-dilutive value lever, with the most recent PRV transaction valued at approximately US$200 million.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au
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Island Pharmaceuticals Limited-FDA Alignment Accelerates Galidesivir Pathway
Island Pharmaceuticals Limited (ASX: ILA) has received highly constructive guidance from the US Food and Drug Administration, confirming the development pathway for Galidesivir under the FDA’s Animal Rule and materially reducing regulatory uncertainty. The FDA has validated Island’s proposed animal model, including the use of the Angola strain of Marburg virus, the cynomolgus macaque model and the challenge dose, establishing the core foundations required for approval. Importantly, a clearly defined two-stage development sequence has been outlined, allowing the program to progress through targeted dose optimisation and pharmacokinetic studies before entering a pivotal confirmatory phase.
Island is positioned to commence these studies immediately using its first manufactured batch of Galidesivir, with engagement well advanced with Texas Biomedical Research Institute and additional partners to accelerate timelines. Approval under the Animal Rule may unlock US Government procurement opportunities, including potential inclusion in the Strategic National Stockpile. In addition, successful approval would entitle Island to a Priority Review Voucher, a significant non-dilutive value lever, with the most recent PRV transaction valued at approximately US$200 million.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au