The US FDA designated Fast Track development program for the investigation of Endogena Therapeutics' product EA-2353 for the treatment of Retinitis Pigmentosa (RP).
The Fast Track is a process designed to enable patients to benefit earlier from important new drugs that treat serious conditions. This designation enables Endogena Therapeutics to have more frequent communications with the US FDA on the development of EA-2353 and allow more rapid regulatory review of the future new drug application.
In May 2021, the FDA granted EA-2353 orphan drug designation.
EA-2353 a novel small-molecule . . .