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Island Pharmaceuticals Awaits Extended FDA Review as Galidesivir Preparations Advance

Story Highlights
  • Island Pharmaceuticals says the FDA needs more time reviewing Galidesivir but maintains a positive regulatory stance.
  • The company continues Marburg study preparations and US stakeholder talks to accelerate Galidesivir’s next development phase.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Island Pharmaceuticals Awaits Extended FDA Review as Galidesivir Preparations Advance

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Island Pharmaceuticals Ltd ( (AU:ILA) ) just unveiled an update.

Island Pharmaceuticals has reported that the US Food & Drug Administration has requested additional time to finalise its response on the regulatory development pathway for Galidesivir under the Animal Rule, but has not issued any adverse feedback, sought extra data or changed its previously positive stance, including eligibility for Priority Review Voucher status. While awaiting more detailed guidance that will shape planned non-human primate studies in Marburg virus and broader clinical trial plans, the company is continuing study preparations, engagement with US government stakeholders and negotiations with potential study partners, positioning itself to move quickly into the next phase of Galidesivir’s development once the FDA’s program approval and clarifications are received.

The most recent analyst rating on (AU:ILA) stock is a Hold with a A$0.42 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 listed on the ASX that focuses on treatments for urgent viral diseases, public health emergencies and biosecurity threats. The company is pursuing a dual development strategy for its assets ISLA-101, a repurposed drug targeting dengue fever and other mosquito-borne diseases, and Galidesivir, a clinical-stage broad-spectrum antiviral active against more than 20 RNA viruses including high-priority threats such as Ebola, Marburg, MERS, Zika and Yellow fever.

Average Trading Volume: 536,745

Technical Sentiment Signal: Buy

Current Market Cap: A$117M

See more data about ILA stock on TipRanks’ Stock Analysis page.

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