ATX.ASX: Positive Response from US FDA to Amplia's Type D Meeting

Positive Response from US FDA to Amplia's Type D Meeting

Stock	Amplia Therapeutics Ltd (ATX.ASX)
Release Time	20 Nov 2025, 9:59 a.m.
Price Sensitive	Yes

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Amplia Receives Positive FDA Feedback on Planned Phase 2b/3 Trial

Key Points

Favourable response from US FDA on Amplia's planned Phase 2b/3 trial for pancreatic cancer
FDA supports the two-dose comparison strategy in the Phase 2b study, leading into the pivotal Phase 3
Full trial protocol to be prepared for FDA review in H1 2026, supporting goal to commence registration-enabling study in late 2026

Full Summary

Amplia Therapeutics has received favourable responses from the US FDA during a Type D meeting regarding its planned Phase 2b/3 trial combining narmafotinib with gemcitabine and Abraxane for pancreatic cancer. The FDA supports the two-dose comparison envisaged in the Phase 2b study, leading into the pivotal Phase 3 stage of the trial, and the minor changes proposed will have minimal effect on planned timelines. The full trial protocol will now be prepared for FDA review in H1 2026, supporting the goal to commence the registration-enabling study in late 2026. Dr Chris Burns, CEO and Managing Director of Amplia, commented that the FDA's response gives confidence in meeting current projected timelines for the Phase 2b/3 study. 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.