Neuren Pharmaceuticals slumps despite receiving FDA meeting feedback
Make us a preferred source
Make us a preferred source on Google
More news: Shares in Neuren Pharmaceuticals fell sharply in morning trade despite the company receiving meeting feedback from the FDA regarding the development of its NNZ-2591 drug to treat hypoxic-ischaemic encephalopathy and Pitt Hopkins syndrome .
Shares were 7.04% lower to $13.60 at 12:19pm AEDT.
Neuren Pharmaceuticals receives meeting feedback from the FDA
The news: Neuren Pharmaceuticals received meeting feedback from the US Food and Drug Administration (FDA) regarding the development of its NNZ-2591 drug to treat hypoxic ischaemic encephalopathy (HIE) and Pitt Hopkins syndrome (PTHS).
The context: The feedback follows Neuren's request for a Type B pre-Investigational New Drug (IND) for HIE and Type C meetings for PTHS. The FDA determined that both meetings would be conducted via written responses only.
The regulator requested additional juvenile animal study data to support the proposed dosing in neonatal participants ahead of the clinical study.
HIE is a rare brain injury that occurs when a newborn’s brain is deprived of oxygen or blood flow shortly after birth. PTHS is a rare neurodevelopmental disorder caused by the loss or mutation of one copy of the TCF4 gene on chromosome 18.
What they said: "We remain comitted to advancing NNZ-2591 as a potential treatment option for both the HIE and PTHS communities. In the meantime, we anticipate being able to provide an update shortly on progress in the ongoing Koala Phase 3 trial in Phelan-McDermid syndrome", Neuren CEO Jon Pilcher said.
The source: ASX
