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Montserrat

Amplia Therapeutics Limited

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Amplia 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

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 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,

“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.”

Positive Response from US FDA to Amplia Therapeutics’ Type D Meeting