Latest Island Pharmaceuticals (ASX:ILA) News

Island Pharmaceuticals has engaged a top Washington DC government affairs firm to accelerate its US biodefence strategy, focusing on its antiviral drug Galidesivir amid promising FDA regulatory signals.

Island Pharmaceuticals has secured FDA confirmation that its antiviral Galidesivir can proceed under the Animal Rule pathway for Marburg virus, qualifying for a lucrative Priority Review Voucher. This regulatory milestone accelerates the drug’s path to approval and potential government stockpile inclusion.

Island Pharmaceuticals will host a webinar to discuss the FDA's feedback on the clinical development and regulatory approval of its antiviral drug Galidesivir, including key considerations under the FDA's Animal Rule and Priority Review Voucher eligibility.

Island Pharmaceuticals has completed its acquisition of the broad-spectrum antiviral Galidesivir and is progressing regulatory discussions with the FDA to fast-track approval using the Animal Rule, backed by compelling preclinical data.

Island Pharmaceuticals secures FDA confirmation that regulatory feedback on Galidesivir’s approval pathway will arrive on schedule, underscoring the drug’s strategic importance amid US government disruptions.

Island Pharmaceuticals has submitted a detailed briefing to the FDA aiming to accelerate approval of its antiviral Galidesivir for Marburg virus under the Animal Rule, with feedback expected by November.

Island Pharmaceuticals has won a crucial FDA Type C meeting to discuss fast-tracking its antiviral Galidesivir for Marburg virus treatment, with written feedback expected by November.

Island Pharmaceuticals has formally requested a Type C meeting with the US FDA to discuss accelerating approval of its antiviral Galidesivir for Marburg virus using the Animal Rule pathway.

Island Pharmaceuticals reported a $3.92 million loss for FY2025 despite an 86% increase in income, with no dividends declared.

Island Pharmaceuticals has raised $350,000 through an options exercise by substantial shareholder MWP Partners, reinforcing confidence in its antiviral drug development pipeline.

Island Pharmaceuticals has completed its acquisition of the broad-spectrum antiviral Galidesivir ahead of schedule, setting sights on expedited FDA approval leveraging the Animal Rule.

Island Pharmaceuticals reported promising Phase 2a/b trial results for its dengue drug ISLA-101 and secured a strategic acquisition of the broad-spectrum antiviral Galidesivir, bolstering its pipeline and balance sheet.