I don’t believe that Neuren has to seek the approval of Acadia /the JSC with respect to any new indications of NNZ-2591.
Certainly, none of the preclinical work it has completed to date, specific to further NNZ-2591 indications, has to be shared with Acadia/the JSC because it’s not yet publicly disclosed (Ref: 5.6 (b) (iv)). Hence, while we don’t know what further indications Neuren is pursuing, nor will Acadia.
Once the NNZ-2591 new indications are disclosed, my interpretation is that Neuren is only obliged to share with Acadia information that is non-indication specific and that relates to safety, tolerability and CMC.
On the other hand, it is quite clear that Acadia does have to share with Neuren/the JSC any proposal to develop trofinetide outside of Rett syndrome or Fragile-X syndrome. ACADIA must inform and seek the approval of the JSC (Ref: 6.2 (a)).
If indeed there is an A list of ~4 indications and a B list of another 10 indications, my thinking would be that the A group is more advanced, possibly ready now to be advanced to Phase 2 studies, whereas the B list waits in line, remaining undisclosed.
NEU Price at posting:
$12.81 Sentiment: Hold Disclosure: Held
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