USFDAMay 6, 2026, 08:03 AM
Taysha Gene Therapies reaffirms FDA alignment for TSHA-102 BLA pathway
AI Summary
Taysha Gene Therapies reaffirmed FDA alignment on the Biologics License Application (BLA) pathway for TSHA-102, including pivotal trial design and the potential to submit for approval based on a six-month interim analysis from the REVEAL pivotal trial. The company also advanced dosing in the REVEAL and ASPIRE trials, expecting completion in Q2 2026, and initiated a BLA-enabling PPQ campaign. For Q1 2026, Taysha reported a net loss of $42.4 million, or $0.12 per share, with $276.6 million in cash and cash equivalents, sufficient to fund operations into 2028.
Key Highlights
- FDA alignment reaffirmed for TSHA-102 BLA pathway, including pivotal trial design.
- Potential to submit BLA based on REVEAL pivotal trial 6-month interim analysis.
- Dosing in REVEAL and ASPIRE trials on track for completion in Q2 2026.
- TSHA-102 maintained favorable tolerability with no treatment-related SAEs or DLTs.
- BLA-enabling PPQ campaign for TSHA-102 initiated in April 2026, completion Q4 2026.
- Q1 2026 Net Loss was $42.4 million, or $0.12 per share.
- Q1 2026 R&D expenses increased by $18.2 million to $33.8 million.
- Cash and cash equivalents of $276.6 million as of March 31, 2026, funding into 2028.