Novel approaches to support therapeutic development in ultra-rare cancers

Expected deadline

Not stated

Who can apply

Small businesses

Award range

Not stated

Expected awards

2

Total program funding

Not stated

Your own money required

No cost sharing or matching required

Opportunity number

FOR-FD-26-004

Posted

Aug 4, 2025

Assistance listing

93.103

What it funds

The purpose of this program is to support new approaches that can be applied to facilitate therapeutic development in ultra-rare pediatric and adult cancers, including molecularly-defined subsets of more common cancers. Specific areas of interest include, but are not limited to, the following examples:• Development of infrastructure for a coordination network and data repository for patient-level data across institutions and internationally to support drug development and regulatory decision-making for one or more ultra-rare cancers.• Investigations to explore opportunities to develop and validate early clinical endpoints and other novel efficacy endpoints for evaluation of treatments for ultra-rare cancers.• Development and implementation of a collaborative multi-stakeholder effort to support generation and use of real-world data leveraging a registry framework for use in development of new therapies for pediatric patients with diffuse midline glioma (DMG) (including diffuse intrinsic pontine glioma, DIPG). • Innovative approaches to identify new biologically-driven opportunities for clinical development of previously approved drugs or biologics (hereafter referred to as drugs), including drugs for which development has been discontinued, in ultra-rare cancers.• Research to develop novel approaches to preserve the availability of drugs for which commercial developers have discontinued adult development that have strong potential in ultra-rare cancers but lack financial incentives for commercial development• Development of methods to incorporate use of telemedicine and/or pragmatic trial design elements (e.g., collecting laboratory and/or imaging data from local facilities) for patient assessments to facilitate enrollment of patients with ultra-rare cancers• Development…

What to do next

1. This is a forecast: the agency expects to post the full notice later. Open it on Grants.gov and subscribe there to be told when it posts.
2. Get your SAM.gov registration ("all awards") and Grants.gov account active now; both take time.
3. Use the forecast's award range and eligibility to decide whether to prepare.
4. Watch for the notice; the dates here are estimates and can change.

New to this? Applying for a federal grant, step by step · Register to apply · How to read the notice · Write the narrative · Build the budget · Agency contact: patrick.johnson@fda.hhs.gov

From Grants.gov's official daily extract of Oct 25, 2026. The notice on Grants.gov and its attachments are what count. UX Contract is independent and not a government website.