The goal of this funding opportunity announcement (FOA), from the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), is to support preclinical development and testing of new therapies for neuromuscular diseases. The program will facilitate solicitation, development, and review of therapy-directed projects to accelerate the translation of basic research discoveries into therapeutic candidates for clinical testing. This program is specifically directed at projects that include therapeutic leads with demonstrated activity against the intended disease target. The program supports preclinical optimization and testing of these leads and projects must be sufficiently advanced that an IND or IDE application to the FDA can be submitted by the end of the project period. The program does not support early-stage therapeutic discovery activities such as high throughput screening. The program also excludes clinical research, basic research, and studies of disease mechanism. This is a milestone-driven cooperative agreement program involving participation of NIH staff in the development of the project plan and monitoring of research progress.