Island Pharmaceuticals Says US FDA Confirms Animal Model as Development Pathway for Antiviral Drug Candidate; Shares Rise 10%
MT Newswires Live
Feb 04
Island Pharmaceuticals (ASX:ILA) said the US Food and Drug Administration confirmed its proposed animal model as the development pathway for its antiviral drug candidate, Galidesivir, according to a Wednesday filing with the Australian bourse.
The US FDA confirmed the core elements of the proposed animal model, including the use of the Angola strain of Marburg, and outlined the final steps required to develop Galidesivir toward approval under the Animal Rule, the filing said.
Under the two-stage clinical development pathway, the company will start targeted dose optimization and pharmacokinetic studies using the first manufactured batch of Galidesivir, the filing added.
Shares of the company rose past 10% in recent Wednesday trade.
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