earnings
confidence high
sentiment positive
materiality 0.75
Taysha Q1 net loss $42.4M; FDA aligns on TSHA-102 BLA submission pathway
Taysha Gene Therapies, Inc.
2026-Q1 EPS reported
-$0.12
- Net loss $42.4M ($0.12/sh) vs $21.5M ($0.08/sh) Q1 2025; R&D expense doubled to $33.8M on PPQ and clinical costs.
- Cash $276.6M; company expects runway into 2028.
- FDA reaffirmed alignment on TSHA-102 BLA pathway including pivotal trial design, endpoints, and potential 6-month interim submission.
- Dosing in REVEAL pivotal and ASPIRE trials on track for Q2 2026 completion; no treatment-related SAEs or DLTs to date.
- BLA-enabling PPQ campaign initiated April 2026; completion expected Q4 2026.