Taysha granted rare pediatric disease and orphan designations for TSHA-105

US AAV-based gene therapies developer Taysha Gene Therapies (Nasdaq: TSHA) today announced that it has received both rare pediatric disease and orphan drug designations from the US Food and Drug Administration for TSHA-105, an AAV9-based gene therapy in development for SLC13A5-related epilepsy.

News of the coveted designations saw Taysha shares leap 17.9% to $29.58 in pre-market trading this morning.

“There are no approved therapies for epilepsy caused by SLC13A5 that address the underlying cause of this disease,” said RA Session II, president, founder and chief executive of Taysha. “We are encouraged by the early evidence of TSHA-105’s disease-modifying approach and believe these designations will help us potentially accelerate the development of this exciting program. We look forward to working with the FDA to make TSHA-105 available to patients as expeditiously as possible,” he noted.