The initiative is part of the FDA's broader effort to expedite the evaluation process for therapies that utilize established technological frameworks.

On June 4, 2025, the U.S. Food and Drug Administration (FDA) granted Sarepta Therapeutics a 'platform technology designation'.

This designation positions Sarepta as one of the first companies to receive this recognition, which aims to streamline regulatory reviews for future gene therapy applications.

This decision highlights the FDA's commitment to support innovation in addressing complex medical conditions that currently have limited treatment options.

By receiving this designation, Sarepta could potentially accelerate the assessment of treatments targeting rare diseases, thereby enhancing access to innovative therapies.