On November 20, 2025 Amplia Therapeutics Limited (ASX: ATX; OTCQB: INNMF), referred to as "Amplia" or "the Company," reported it has received positive feedback from the US Food and Drug Administration (FDA) in response to questions posed by the Company as part of a recent Type D meeting.

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The Company received a positive response to the Type D questions around the dose optimisation strategy for narmafotinib in the proposed registration-enabling Phase 2b/3 trial which will investigate the combination of the Company’s lead compound, narmafotinib, in combination with gemcitabine and Abraxane in pancreatic cancer. The FDA’s response gives confidence in meeting current projected timelines for the Phase 2b/3 study planned to commence in late 2026. The full protocol will now be prepared for submission for FDA comment in H1 2026.

Dr Chris Burns, CEO and Managing Director of Amplia, commented, "FDA’s response supports the dose comparison design of the Phase 2b portion of this trial prior to the pivotal Phase 3 stage. We see this as a positive outcome as the changes proposed will have minimal impact to the trial timeline. This feedback also allows us to better plan the trial, and a full protocol will now be drafted for FDA comment in H1 2026."

A Type D meeting is a formal interaction with the FDA that allows companies to obtain focused feedback on specific regulatory questions outside of a standard review cycle.

(Press release, Amplia Therapeutics, NOV 20, 2025, View Source [SID1234660097])