Amplia Therapeutics’ Drug Fast-Tracked by FDA

Amplia Therapeutics Ltd. (AU:ATX) has released an update.

Amplia Therapeutics Ltd has received Fast Track Designation from the FDA for narmafotinib, their leading drug for treating advanced pancreatic cancer, which may expedite the drug’s review and approval process. This significant milestone allows for more frequent interactions with the FDA, potentially leading to Accelerated Approval and Priority Review. Amplia is already conducting the ACCENT clinical trial in Australia and South Korea, with plans for a US trial underway.

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