Taysha Gene Therapies: sinimulan ang BLA-enabling PPQ campaign para sa TSHA-102

Sinimulan ni Taysha ang BLA-enabling Process Performance Qualification (PPQ) campaign para sa TSHA-102 noong Abril 2026 gamit ang commercial manufacturing process, at inaasahang matatapos ito sa Q4 2026. Inendorso ng FDA ang PPQ campaign strategy kasunod ng Type C meeting noong Enero 2026. Ang CMC milestone na ito ay umaayon sa manufacturing activities sa nakaplanong BLA submission timeline para sa TSHA-102 sa Rett syndrome.

Mahahalagang fact

Na-file: May 6, 2026, 12:11 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Positibo
Kumpanya: TSHATaysha Gene
Asset: TSHA-102
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

EX-99.1 2 d99032dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Taysha Gene Therapies Reports First Quarter 2026 Financial Results and Provides Corporate Update Reaffirmed FDA alignment on TSHA-102 BLA pathway, including pivotal trial design, endpoints and potential to submit for approval based on REVEAL pivotal trial 6-month interim analysis, following recent breakthrough therapy Type B meeting Further advanced dosing in the REVEAL pivotal trial, with enrollment in the ASPIRE trial ongoing across multiple sites; on track to complete dosing in REVEAL and ASPIRE in Q2 2026 Maintained favorable tolerability profile with no treatment-related SAEs or DLTs in REVEAL Phase 1/2 and REVEAL pivotal trials as of May 2026 data cutoff; plan to present longer-term safety and efficacy data from Part A of R

SEC 8-K