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Amplia Therapeutics Limited (ASX:ATX)

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Current share price for ATX : $0.140 0.025 (21.74%)+
Announcement
Release
20 Nov 2025 9:59AM
Price at Release
$0.115
Full Release
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Summary
Amplia Therapeutics Limited, an Australian pharmaceutical company focusing on FAK inhibitors for cancer, has received favourable feedback from the US FDA following a Type D meeting. This relates to their planned Phase 2b/3 clinical trial involving their lead compound narmafotinib, in combination with gemcitabine and Abraxane, for the treatment of pancreatic cancer. The FDA has endorsed their dose optimisation strategy, which is a positive step towards commencing the registration-enabling study by late 2026. Amplia's narmafotinib has shown improved response rates in current trials compared to existing treatments, supporting its potential as a promising therapeutic option.
Key Points
  • Amplia Therapeutics Limited received a positive response from the US FDA during a Type D meeting for their planned Phase 2b/3 trial involving narmafotinib, gemcitabine, and Abraxane for pancreatic cancer.
  • The FDA supports the two-dose comparison in the Phase 2b study leading into the pivotal Phase 3 stage.
  • The proposed changes will minimally impact the planned timelines for the trial.
  • The full trial protocol is set to be prepared for FDA review in the first half of 2026, with the study expected to start in late 2026.
  • A Type D meeting is a formal FDA interaction allowing companies to obtain specific regulatory feedback outside the standard review cycle.
  • Amplia's primary compound, narmafotinib (AMP945), is a FAK inhibitor used in treating pancreatic cancer.
  • The ACCENT trial has shown promising results with narmafotinib, achieving a confirmed response rate of 33%.
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.