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Taysha Gene Therapies, Inc. (TSHA) filed an 8-K current report with the SEC on June 22, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.2). Exhibit 99.1 furnished under Regulation FD, with disclosure not deemed filed under Exchange Act Section 18.
Taysha Gene Therapies, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Exhibit 99.1 furnished under Regulation FD, with disclosure not deemed filed under Exchange Act Section 18
- Liability protections limit use in other SEC filings unless expressly incorporated by reference
Item 8.01 · Other Events
- Presentation covers clinical and regulatory updates for TSHA-102
- Exhibit 99.2 contains the materials, providing investors detail beyond the brief 8-K disclosure
- Regulatory and clinical updates may affect TSHA-102 development timing and perceived program risk
Item EX-99.1 · Exhibit EX-99.2
- REVEAL pivotal trial dosing completed in 17 patients, advancing TSHA-102 toward a 6-month interim efficacy analysis
- FDA-aligned efficacy threshold is 33% responders versus a 6.7% natural-history null hypothesis
- Part A showed 100% milestone response among 12 patients, with 310 total functional gains at ≥12 months
- No treatment-related SAEs or DLTs reported across 29 treated patients as of June 2026
- Topline pivotal data and FDA feedback on the BLA pathway expected in 1H 2027
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
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