ASX:ILA

5 stories mentioning ASX:ILAUpdated 32m ago

Every FINWIRES story that references ASX:ILA, newest first.

Island Pharmaceuticals Secures US FDA Orphan Drug Status for Antiviral Candidate

Island Pharmaceuticals (ASX:ILA) secured an Orphan Drug Designation from the US Food and Drug Administration (FDA) for its antiviral candidate Galidesivir as a post-exposure prophylaxis for Marburg virus disease, according to a Wednesday filing with the Australian bourse.The designation offers regulatory and commercial benefits, including up to seven years of US market exclusivity if approved, along with fee waivers and increased FDA support, per the filing.The company also noted recent progress, including an expanded Cooperative Research and Development Agreement with the US Army Medical Research Institute of Infectious Diseases, securing a non-human primate supply for upcoming dose-optimization studies, and initiating GMP manufacturing.The company said that preparations for pivotal studies are ongoing, with the next development phase expected to start in the next quarter, the filing added.

ASX:ILA

Asia7d ago

Island Pharmaceuticals Secures Agreement Expansion With US Army Medical Research Institute of Infectious Diseases; Shares Up 3%

Island Pharmaceuticals (ASX:ILA) secured an expansion to its cooperative research and development agreement with the US Army Medical Research Institute of Infectious Diseases, a part of the Defense Health Agency and The Geneva Foundation for Medical Research, according to a Wednesday filing with the Australian bourse.The expanded agreement confirms the company's planned dose optimization study evaluating Galidesivir, its treatment candidate for Marburg virus disease, the filing said.The study is expected to start next quarter with topline results in the second half of the year, per the filing.Shares rose 3% in morning trade on Wednesday.

ASX:ILA

Asia13d ago

Island Pharmaceuticals Executes Agreement for GMP Manufacturing Campaign for Drug Candidate

Island Pharmaceuticals (ASX:ILA) executed an agreement with PI Health Sciences for a good manufacturing practices (GMP) campaign to produce its Galidesivir drug candidate to support pivotal studies, according to a Thursday Australian bourse filing.The agreement also includes analytical method validation, reference standard preparation, and stability studies. The campaign is designed to validate and scale production to a level appropriate for late-stage development. Manufacturing activities have begun.The manufacturing will support its planned Marburg virus disease development program under the US Food and Drug Administration's (FDA) Animal Rule pathway.

ASX:ILA

Asia29d ago

Island Pharmaceuticals Appoints Senior Global Health Security Adviser Ahead of Animal Rule Studies for Antiviral Drug Candidate; Shares Drop 6%

Island Pharmaceuticals (ASX:ILA) appointed US biodefense executive Mark Herzog as senior global health security adviser ahead of the start of its Animal Rule studies for galidesivir in Marburg virus disease, according to a Tuesday Australian bourse filing.Marburg virus disease, formerly known as Marburg haemorrhagic fever, is a fatal illness caused by the Marburg virus, according to the World Health Organization website.The company said it is on track to begin planned dose optimization studies in the September quarter, adding that it remains in advanced negotiations with US-based BSL-4 biocontainment facilities regarding the execution of its planned two-stage development pathway.Island Pharmaceuticals' shares dropped 6% in recent trading on Tuesday.

ASX:ILA

Asia50d ago

Island Pharmaceuticals Works Alongside USAMRIID to Advance Clinical Development For Galidesivir

Island Pharmaceuticals' (ASX:ILA) work alongside the US Army Medical Research Institute of Infectious Diseases (USAMRIID) and Texas Biomedical Research Institute is well progressed, with the next phase of clinical development for its Galidesivir drug candidate expected to start shortly, according to a Monday Australian bourse filing.It received around a AU$143,000 refund under the Australian Government's research and development tax incentive for the fiscal year 2025. The refund relates to eligible expenditure associated with the ongoing development of ISLA-101.It worked alongside Todd Strategy Group and MC2 to advance industry engagement initiatives in the US during the March quarter.Galidesivir is a clinical-stage antiviral molecule with broad-spectrum activity against over 20 RNA viruses, including Ebola, Marburg, MERS, Zika, and Yellow fever, the filing added.Its shares were up 1% in recent trading on Monday.

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