BridgeBio affiliate has NDA accepted

California, USA’s BridgeBio Pharma (Nasdaq: BBIO) has announced that its affiliate QED Therapeutics has had its New Drug Application (NDA) accepted by the US Food and Drug Administration (FDA) for infigratinib, an oral FGFR1-3 selective inhibitor, for cholangiocarcinoma.

The NDA has been granted Priority Review designation and is being reviewed under the Real-Time Oncology Review pilot program, an initiative of the FDA’s Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients.

BridgeBio will submit for review in Australia and Canada under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies.