Island Pharmaceuticals Says US FDA Needs More Time to Review Galidesivir Submission

MT Newswires Live
Jan 05

Island Pharmaceuticals (ASX:ILA) said the US Food and Drug Administration (FDA) needs additional time to respond to its recent submission on the clinical development of galidesivir under the animal rule, according to a Monday Australian bourse filing.

Galidesivir is a clinical-stage molecule being developed for use against various viruses, including Ebola and yellow fever.

The US FDA has not raised any concerns or requested additional information, and the company continues to engage in constructive dialogue, per the filing.

The company is advancing preparatory work, including organizing a non-human primate study and coordinating with US government stakeholders, and is prepared to implement FDA guidance and move forward with study initiation once approval is granted, the filing added.

The company's shares rose 2% in recent Monday trade.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10