FDA Backs Island Pharmaceuticals’ Galidesivir Pathway, Opening Route to Accelerated Approval

Island Pharmaceuticals Ltd ( (AU:ILA) ) has issued an announcement.

Island Pharmaceuticals has secured key guidance from the US Food and Drug Administration validating its proposed animal model for Galidesivir and setting out a two-stage development pathway under the FDA’s Animal Rule, a milestone the company says significantly de-risks the program. The FDA’s alignment on the use of the Angola strain of Marburg virus in cynomolgus macaques allows Island to immediately commence dose-optimisation and pharmacokinetic studies using its first manufactured batch of Galidesivir at Texas Biomedical Research Institute and other potential partners, ahead of a pivotal confirmatory study that could lead to approval, unlock US government stockpile procurement opportunities, and qualify the company for a potentially highly lucrative Priority Review Voucher.

The most recent analyst rating on (AU:ILA) stock is a Hold with a A$0.39 price target. To see the full list of analyst forecasts on Island Pharmaceuticals Ltd stock, see the AU:ILA Stock Forecast page.

More about Island Pharmaceuticals Ltd

Island Pharmaceuticals Ltd is an Australian antiviral drug development company focused on developing treatments for high-consequence viral threats. Listed on the ASX, the company’s lead asset is Galidesivir, an antiviral candidate being advanced as a medical countermeasure with a particular focus on US biodefence needs and potential procurement for the Strategic National Stockpile.

Average Trading Volume: 556,089

Technical Sentiment Signal: Buy

Current Market Cap: A$104.9M

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