June 2018. US FDA Grants Regenera Pharma Fast Track Designation


United States Food and Drug Administration (FDA) has granted Fast Track designation to Regenera’s leading drug candidate, RPh201, for treatment of non-arteritic anterior ischemic optic neuropathy (NAION).

This designation offers Regenera earlier and more frequent opportunities to collaborate with the FDA to expedite development of RPh201, bringing this treatment more quickly to the patients who need it. This status also provides an opportunity for Priority Review and submission of completed sections of a New Drug Application (NDA) on a rolling basis prior to completion of the full application.

The FDA’s Fast Track designation facilitates the development of new therapies that treat serious conditions and fulfill an unmet medical need in an effort to get treatments to those in need sooner.