Ultra-Rare Gene-based Therapy (URGenT) Network Resource Access (X01, Clinical Trial Not Allowed)
ID: 357815Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The National Institutes of Health (NIH) is inviting applications for the Ultra-Rare Gene-based Therapy (URGenT) Network Resource Access program under funding opportunity number PAR-25-326. This initiative aims to facilitate access to contract research organizations and subject matter experts to support nonclinical development activities for gene-based therapies targeting ultra-rare neurological and neuromuscular diseases. The program emphasizes the urgency of developing tailored therapies due to the critical nature of these conditions and the lack of existing commercial therapeutic options, encouraging proposals that demonstrate proof of concept data for defined patient populations. Applications are accepted on a rolling basis, with a close date of January 31, 2028, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries. Additional details can be found at the provided link: https://grants.nih.gov/grants/guide/pa-files/PAR-25-326.html.

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    Title
    Posted
    The National Institutes of Health (NIH) is inviting applications for the Ultra-Rare Gene-based Therapy (URGenT) Network Resource Access program under the funding opportunity number PAR-25-326. This initiative aims to facilitate access to contract research organizations and subject matter experts to support nonclinical development activities for gene-based therapies targeting ultra-rare neurological and neuromuscular diseases. The program encourages proposals that demonstrate proof of concept data for a defined patient population, addressing significant unmet medical needs. Key activities include planning and limited nonclinical studies that may lead to an Investigational New Drug (IND) application with the FDA. Applications are accepted on a rolling basis with specific submission deadlines, focused on enhancing access to URGenT resources, developing product plans, and ensuring regulatory compliance. The program does not provide direct funding but offers support through access to specialized resources to aid in the advancement of therapeutics for ultra-rare diseases. This NOFO emphasizes the urgency of developing tailored therapies due to the critical nature of these conditions and the lack of existing commercial therapeutic options.
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