tiprankstipranks
Trending News
More News >
Advertisement
Advertisement

Island Pharmaceuticals Advances Galidesivir Approval with FDA Submission

Story Highlights
  • Island Pharmaceuticals submitted a briefing document to the FDA for Galidesivir’s approval.
  • The FDA’s response will guide the company’s next steps, including a Marburg study.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Island Pharmaceuticals Advances Galidesivir Approval with FDA Submission

Elevate Your Investing Strategy:

  • Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.

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

Island Pharmaceuticals Ltd has submitted a comprehensive briefing document to the US Food & Drug Administration (FDA) for a Type C meeting to advance the approval pathway of its antiviral drug, Galidesivir. The submission aims to align with the FDA on using the Animal Rule for Galidesivir’s clinical development and approval, with written responses expected by November 12, 2025. This step is crucial for the company’s regulatory strategy and involves finalizing negotiations with a strategic counterparty for a planned animal study in Marburg, which is expected to be completed by the fourth quarter of 2025.

More about Island Pharmaceuticals Ltd

Island Pharmaceuticals Ltd is an Australian antiviral drug development company focused on addressing urgent viral diseases, public health, or biosecurity threats. The company is executing a dual development strategy for its assets, ISLA-101 and Galidesivir. ISLA-101 is repurposed for the prevention and treatment of dengue fever and other mosquito-borne diseases, while Galidesivir is a clinical-stage antiviral molecule with broad-spectrum activity against over 20 RNA viruses, including high-priority threats such as Ebola, Marburg, MERS, Zika, and Yellow fever.

Average Trading Volume: 754,577

Technical Sentiment Signal: Buy

Current Market Cap: A$104M

For a thorough assessment of ILA stock, go to TipRanks’ Stock Analysis page.

Disclaimer & DisclosureReport an Issue

Looking for investment ideas? Subscribe to our Smart Investor newsletter for weekly expert stock picks!
Get real-time notifications on news & analysis, curated for your stock watchlist. Download the TipRanks app today! Get the App
1