Here's the announcement on the FDA engagements regarding HIE and PTHS clinical development for NNZ-2591.

ASX Announcement

Basically, Neuren has received written FDA feedback (not a meeting as requested) confirming a clear regulatory path for NNZ-2591 in both HIE and Pitt Hopkins syndrome.

Additional juvenile animal data is required before initiating the HIE IND, i.e., in human Phase 1 clincal trial. So, a minor delay.

And there is alignment that a PTHS-specific CGI plus a functional observer-reported endpoint could support a controlled efficacy trial. Here, I think $NEU are being customarily cautious not to refer to the terms Phase 2 or Phase 3, because we haven't yet heard the readout from the Phase 2 submission currently under consideration. Obviously, $NEU would hope to move into a pivotal Phase 3 trial, but by not using that term now, they avoid a potential future disappointment. Well, that's my reading of it.

Neuren plans to advance both programs in 2026, while continuing its Phase 3 PMS trial, with no material funding impact from the FDA feedback.

I don't consider that this announcement moves the needle one way or the other.

What will in my view move the needle, is any positive update on the ongoing PMS Phase 3 trial. However, as it is a randomised, double-blind, control trial, I think any update will relate to information about progress in enrolment, absence of serious adverse events (maybe), and any update on the foward timeline.

In summary, I don't see a lot here today. Do others have a different view?

Disc: Not held