NEU 0.70% $20.12 neuren pharmaceuticals limited

the BIG reversal

  1. 5,173 Posts.
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    “Neuren is in a far stronger position following the partnership with ACADIA Pharmaceuticals announced today. It makes a very significant and immediate difference in our ability to complete the development of trofinetide for patients in North America and around the world. Importantly, Neuren now has its lead program fully funded, we have access to ACADIA's broad range of capabilities in the US and we have secured significant participation in the potential value of trofinetide in North America, as well as retaining the future value of both trofinetide outside North America and NNZ-2591.“

    Capabilities and funding secured to get trofinetide to market
     Exclusive license to ACADIA for North America, Neuren retains all rights outside
    North America
     Neuren to receive up to US$465 million plus royalties plus share of value of Rare Pediatric Disease Voucher if awarded
     ACADIA provides the strong capabilities and resources required to execute and fund Rett syndrome Phase 3 trial, commencing in H2 2019 following completion of manufacturing activities
     All data and regulatory documents may be freely used by Neuren outside North America
     Neuren now in a position to advance NNZ-2591
     Demonstrated efficacy in models of Parkinson’s disease, stroke, traumatic brain injury, peripheral neuropathy, Fragile X syndrome, memory impairment and multiple sclerosis
     Neuren now has funds to accelerate development

    Demonstrated efficacy in pre-clinical models of Parkinson’s disease, stroke, traumatic brain injury, peripheral neuropathy, Fragile X syndrome, memory impairment and multiple sclerosis
     Funds now available to accelerate CMC and pre-clinical development required prior to clinical trials
     Issued composition of matter patents in US, Japan and all EPO countries except Turkey
     Expire 2024, potential to extend to 2029
     Method of treatment patents and applications for NNZ-2591
     Issued US patent for autism spectrum disorders and neurodevelopmental disorders and pending applications in Europe and Japan – expire 2034
     3 issued US patents for Parkinson’s, peripheral neuropathy and cognitive impairment – expire 2024

    Actively support ACADIA in development of trofinetide in North America
     US Phase 3 program in Rett syndrome  Fragile X syndrome development plan
     Advance Neuren’s strategy to develop and commercialise trofinetide outside North America
     Engage with regulatory authorities to confirm any additional requirements beyond US data for registration in Rett syndrome
     Accelerate development of NNZ-2591
     Advance CMC and toxicology studies to enable clinical trials  Confirm indication strategy to maximise value worldwide
 
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