Ann: Neuren and Acadia expand global partnership for trofinetide, page-102

Terrific discussion on this thread since Friday's announcement.
After a few weeks of downward price action, this announcement has re-ignited the excitement about NEU's future.

I went back through NEU's announcements and it was good to read some of NEU's previous comments.
Particular about NNZ-2591. Some of these potential opportunity areas are not being mentioned in recent announcements or on NEU's website.

NEU ASX Announcement on 28/08/2018

"Neuren is advancing the development of its second drug candidate NNZ-2591, a synthetic analog of theneurotrophic peptide, cyclic glycine proline (cGP), which occurs naturally in the brain. NNZ-2591 hasdemonstrated efficacy in pre-clinical models of Parkinson’s disease, stroke, traumatic brain injury,peripheral neuropathy, Fragile X syndrome, Phelan-McDermid syndrome, Angelman syndrome, PittHopkins syndrome, memory impairment and multiple sclerosis."

>>> Plenty of untapped huge opportunity for NEU to progress following the reporting of the data for the 4 x Ph2 2591 trials currently underway. The potential for these other areas is huge. I also recall a discussion with NEU's Chairmen at the recent AGM about whether 2591 may also be suitable for Diabetes and potentially weight conditions which have IGF-1 associations.


NEU ASX Announcement on 07/08/2018

Announcement about the original NEU-Acadia agreement

"ACADIA and Neuren will form a Joint Steering Committee to direct the development oftrofinetide in all indications, including the next clinical trial for Fragile X syndrome."

>>>> I assume that this joint steering committee will continue under this latest agreement. This is good to know that NEU has a voice at the table and it should prevent each part from crossing each others paths in the development of any new indications for Trof and/or 2591 in North America.


Acadia's Time Line

13/07/2023 Announcment

https://acadia.com/media/news-releases/acadia-pharmaceuticals-acquires-ex-north-american-rights-to-trofinetide-and-global-rights-to-neurens-nnz-2591-in-rett-syndrome-and-fragile-x-syndrome/

"Acadia intends to submit a New Drug Submission (NDS) for trofinetide in Canada in the next 18 months with plans for Europe, Asia and other regions to be announced at a later date."

>>> It looks like Acadia is looking for 12 to 18 months of Daybue sales in US before it starts to expand Daybue outside of the US market. THey are likely to prep for it before then but be ready to execute when the right time comes. This makes sense as they will provide them with 12+ months of data of dealing with health agencies, customer success stories and customer take-up profiles before it approaches other regulators for approval.


Acadia's Time Line

Data for the 4 x Ph2 2591 trials in PhelanMcDermid syndrome, Angelman syndrome, Pitt Hopkins syndrome and Prader-Willi syndrome is expected to start flowing from the end of this year through to mid 2024.

NEU has stated that it is working on multiple fronts to progress 2591 as quickly as possible and believes it can fund some but not all of the four Phase 3 trials for 2591. So Ph 3 trial planning must be in progress now and I am guessing, but it makes sense, that NEU may have had private confidential discussions with Acadia about this recently.

So I don't think there will be any pressure on Acadia to make a take-over of NEU before the second half of 2024 unless another party(s) emerges and heat up the situation to act earlier. Maybe a tack-over of Acadia may be launched before NEU.

GLTA