DoW Amyotrophic Lateral Sclerosis Research Program, Therapeutic Development Award | HT942526ALSRPTDA

FY26 ALSRP Therapeutic Development Award (TDA) FAQs

What is the FY26 ALSRP Therapeutic Development Award (TDA)?

The FY26 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (TDA) is a discretionary U.S. Department of the Army (USAMRAA) grant opportunity intended to move promising ALS therapies closer to the clinic by funding late-stage preclinical development work.

What is the goal of this award?

The goal is to generate practical, decision-making data that advances a specific therapeutic candidate toward human testing. The program is product-driven and focused on enabling the next major milestone: preparation for an FDA Investigational New Drug (IND) submission.

What stage of research does this funding support?

This award supports work spanning late-stage preclinical development, beginning with validation of therapeutic leads and extending through FDA IND-enabling studies.

Is this funding intended for early discovery or exploratory ALS research?

No. The opportunity is not meant for early discovery, target identification, or exploratory/descriptive science. It is intended for teams that already have a specific therapeutic candidate and are ready for rigorous development work that justifies an IND filing.

Do applicants need to already have a therapeutic lead or compound?

Yes. A key expectation is that applicants must already have lead compounds in hand.

Is proof-of-concept efficacy required before applying?

Yes. Applicants are expected to demonstrate proof-of-concept efficacy in at least one appropriate preclinical ALS model system.

What types of preclinical ALS model systems are considered appropriate?

The notice indicates that appropriate models can include whole-animal and cellular systems. The application should show that the candidate has already cleared an initial efficacy bar in at least one appropriate model.

What makes a project "product-driven" under this opportunity?

Projects are expected to center on advancing a specific therapeutic candidate and generating data that informs go/no-go development decisions on the path toward an IND, rather than building general knowledge or broad resources.

Are biomarkers required as part of the development plan?

Yes. The award emphasizes biomarkers that are directly tied to the proposed therapeutic mechanism and development path, alongside the main therapeutic development work.

What kinds of biomarkers does the program expect applicants to include?

The opportunity highlights mechanism-specific biomarkers that support clinical translation, including biomarkers for target engagement, pharmacodynamic response, and predictive or cohort-selective biomarkers that could improve patient stratification and trial design.

How should biomarkers be connected to the therapy being advanced?

Biomarker efforts should be explicitly integrated into the therapeutic development process for the proposed candidate and should be positioned to materially de-risk and accelerate development (for example, improving clinical study efficiency, patient selection, or interpretation of outcomes for that therapeutic approach).

If relevant biomarkers already exist, what is the expectation?

If biomarkers already exist or are already being developed, the application needs to clearly explain how they will be used to improve clinical study efficiency, patient selection, or outcome interpretation for the specific therapeutic candidate.

What biomarker work is not responsive to this opportunity?

Biomarker development aimed mainly at diagnosis, prognosis, or general disease progression measurement is not responsive if it is not explicitly integrated into the therapeutic development process for the proposed therapeutic candidate. The program is not intended to build generic ALS biomarker resources.

Is ALS-specific expertise expected on the project team?

Yes. The announcement emphasizes that ALS-specific expertise matters. Applicants without deep ALS experience are strongly encouraged to include collaborators with substantial familiarity with ALS models, endpoints, and disease pathophysiology.

Why does the opportunity encourage involving ALS-experienced collaborators?

The stated purpose is to reduce the risk of using poorly predictive models or endpoints and to help ensure studies are designed in ways the ALS field recognizes as meaningful and translatable.

Are therapeutic candidates that already have an FDA IND eligible?

No. Therapeutic candidates that have already been granted an IND are explicitly not appropriate for this award mechanism.

What is the intended IND status of candidates supported by this award?

The award is aimed at candidates that have not yet reached the IND stage and is meant to fund the work that bridges the gap to IND submission.

Who is the sponsoring agency for this grant opportunity?

The grant opportunity is offered through the U.S. Department of the Army (USAMRAA).

What is the Funding Opportunity Number (FON) for this award?

The Funding Opportunity Number is HT942526ALSRPTDA.

What category does this opportunity fall under?

It is listed in the science and technology/research and development category.

What is the CFDA number associated with this opportunity?

The CFDA number provided is 12.420.

Is eligibility restricted to certain organization types?

Eligibility is listed as unrestricted in the provided notice.

What is the application closing date?

The closing date is September 30, 2026.

How many awards does the agency expect to make?

The agency anticipates making about six awards.

Is there a specified maximum award amount (award ceiling)?

No. The award ceiling is not specified in the provided notice.