NasdaqGS:TSHABiotechs
Why Taysha Gene Therapies (TSHA) Is Down 5.1% After FDA Alignment On TSHA-102 Safety Data
Taysha Gene Therapies recently reported that it has dosed the first patient in its REVEAL pivotal trial of TSHA-102 for Rett syndrome and secured written FDA alignment to include safety data from the ASPIRE trial in its planned Biologics License Application.
This combination of clinical progress and regulatory clarity could shape how broadly TSHA-102 is ultimately labeled for patients as young as two.
We’ll now consider how FDA alignment on using ASPIRE safety data in the TSHA-102 filing...