NEU 2.17% $21.22 neuren pharmaceuticals limited

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    From Rettsyndrome.org

    https://www.rettsyndrome.org/blog/1...ments-from-neuren-pharmaceuticals-an-overview


    Three Significant Trofinetide Announcements from Neuren Pharmaceuticals: An Overview
    November 24, 2015

    Neuren Pharmaceuticals has made three significant announcements in the last two months regarding trofinetide, the drug candidate they are developing as a treatment for Rett syndrome.  We at Rettsyndrome.org would like to take an opportunity to summarize these recent activities that give us great hope for a rising treatment. In the spirit of Thanksgiving, we give thanks to those who made these advancements possible:  Neuren Pharmaceuticals and their shareholders, scientists, clinicians, physicians, nurses, study coordinators, government regulatory officials, our donors, the trial participants, and all families affected by Rett syndrome.


    “New US patent covering use of trofinetide for Rett syndrome”
    October 12, 2015
    The US Patent and Trademark Office issued a Notice of Allowance for a new patent concerning the use of trofinetide to treat Rett syndrome.  The patent is expected to expire in January 2032, which offers Neuren Pharmaceutical additional protection to their current patent.

    Trofinetide has orphan drug designation in the US and in Europe, which gives Neuren market exclusivity following market authorization for seven and ten years, respectively.

    Read the full press release.


    “IRSF confirms financial support for Neuren's clinical trials”
    October 13, 2015
    Neuren Pharmaceuticals announced the financial support of Rettsyndrome.org for continued development of trofinetide as a treatment for Rett syndrome.  The Phase 2 trial in adults with Rett syndrome showed success in clinical benefit, as observed in core symptoms of Rett syndrome as well as caregivers and caregiver assessments.

    With the funding from Rettsyndrome.org, Neuren Pharmaceuticals will conduct a pediatric trial in children below the age of 16.  The study will determine the tolerability of higher doses and length of treatment in this age group, which will enable Neuren to determine the optimal dose to be used in the subsequent Phase 3 trial.

    Neuren is working with the Food and Drug Administration (FDA) on the Phase 3 trial design that would support the potential approval of a New Drug Application.

    Read the full press release.


    “Shareholders provide further support for Rett syndrome”
    November 9, 2015

    With the financial commitment of Rettsyndrome.org, the shareholders of Neuren agreed to provide an additional level of funding that will accelerate the development of trofinetide for Rett syndrome.

    Neuren Pharmaceutical will issue approximately 70 million new shares to sophisticated investors, and these shares will represent 4% of Neuren’s existing issued shared capital.  Proceeds will fund development of trofinetide for Rett syndrome into 2017.

    In 2016, key activities will include: the pediatric trial, pre-clinical safety studies to support a New Drug Application, and completion of the optimization and scale-up of the commercial manufacturing process.

    Read the full press release.
 
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