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Amplia Therapeutics Limited (ASX:ATX)

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Announcement
Release
19 May 2026 8:18AM
Price at Release
$0.140
Full Release
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Summary
Amplia Therapeutics Limited has announced the initiation of a Phase 2b clinical trial for narmafotinib, a Focal Adhesion Kinase (FAK) inhibitor, in patients with advanced pancreatic cancer. This trial is a registration-enabling study, designed to investigate a new daily dosing regimen of narmafotinib combined with the standard chemotherapies gemcitabine and Abraxane. The study, planned in alignment with FDA feedback, aims to gather data that will support a future Phase 3 trial. Amplia has received orphan drug designation and fast-track status from the U.S. FDA for narmafotinib. The trial will enroll patients at multiple sites in Australia, with patient enrolment expected to begin by Q4 2026.
Key Points
  • Amplia Therapeutics initiates Phase 2b trial for narmafotinib.
  • Focus on daily dosing regimen in combination with gemcitabine and Abraxane.
  • Study designed with input from the FDA to support a Phase 3 trial.
  • Narmafotinib has received FDA orphan drug and fast track designations.
  • Patient enrolment to begin by Q4 2026 across multiple Australian sites.
  • Trial aims to strengthen future FDA submissions.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.