Every 8-K that Taysha Gene Therapies, Inc. (TSHA) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow TSHA and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full TSHA filings page.
Taysha Gene Therapies, Inc. reported second quarter 2026 results and clinical progress for TSHA-102 in Rett syndrome. Dosing was completed in the REVEAL pivotal trial (N=17) and ASPIRE trial (N=4), with TSHA-102 generally well tolerated across 33 patients with no severe treatment-related SAEs or DLTs. Longer-term REVEAL Part A data showed multi-domain functional gains deepening through at least 12 months post-treatment. The company expanded its commercial-readiness efforts, including a broader manufacturing partnership with Catalent.
Research and development expenses were $38.6 million, up from $20.1 million a year earlier, and general and administrative expenses were $12.1 million versus $8.6 million. Net loss for the quarter was $46.6 million, or $0.13 per share, compared with $26.9 million, or $0.09 per share. Following a $230.0 million follow-on offering, cash and cash equivalents totaled $455.4 million at June 30, 2026, which the company expects will fund operations into the second half of 2028. Topline data from the REVEAL pivotal six-month interim analysis and FDA feedback on the TSHA-102 BLA pathway are anticipated in the first half of 2027.
Taysha Gene Therapies is raising about $200.0 million through an underwritten public offering of common stock and pre-funded warrants. The company is selling 32,500,001 common shares at $6.00 each and pre-funded warrants for 833,333 shares at $5.999 per warrant.
Underwriters can buy up to 5,000,000 additional shares within 30 days. Taysha expects net proceeds of about $187.4 million, or $215.6 million if the option is fully exercised. Management believes this cash, combined with existing funds, will finance operations and capital needs into the second half of 2028.
Taysha Gene Therapies reported major clinical and regulatory progress for TSHA-102 in Rett syndrome. The company completed dosing of 17 patients in its REVEAL pivotal trial and shared longer-term Phase 1/2 Part A data in 12 females aged 6–21 years.
Across REVEAL Phase 1/2 and pivotal studies (N=29), TSHA-102 was generally well-tolerated, with no treatment-related serious adverse events or dose-limiting toxicities as of the June 2026 cutoff. In Part A, 100% of patients gained or regained at least one developmental milestone, with 310 total functional gains at ≥12 months, including 31 milestones and 279 additional skill gains.
Regulators have aligned that a 6‑month interim analysis from the pivotal trial may support a potential biologics license application, supplemented by Part A data and safety data from the ASPIRE trial in younger patients. Taysha expects topline interim results and FDA feedback on the BLA pathway in the first half of 2027.
Taysha Gene Therapies, Inc. reported voting results from its 2026 annual meeting of stockholders. Of 287,341,999 shares outstanding on the record date, 243,857,812 shares, or about 84.86%, were present or represented by proxy, indicating strong participation.
Stockholders elected Sean P. Nolan and Laura Sepp-Lorenzino, Ph.D. as directors to serve until the 2029 annual meeting. They also ratified Deloitte & Touche LLP as independent auditor for the year ending December 31, 2026, with 243,814,085 votes in favor.
On a non-binding basis, stockholders approved the compensation of the named executive officers and expressed a preference to hold future advisory votes on executive pay every year. The company plans to hold these say-on-pay votes annually unless the board later determines a different frequency is in stockholders’ best interests.
Taysha Gene Therapies reported first quarter 2026 results and progress on its Rett syndrome gene therapy TSHA-102. The company reaffirmed FDA alignment on its BLA pathway, including pivotal REVEAL trial design, endpoints and the potential to file based on a six-month interim analysis.
Research and development expenses were $33.8 million, up from $15.6 million a year earlier, reflecting BLA-enabling PPQ manufacturing and higher clinical spending on the REVEAL and ASPIRE trials. General and administrative expenses were $9.7 million, compared with $8.2 million.
Taysha reported a net loss of $42.4 million, or $0.12 per share, versus a $21.5 million loss, or $0.08 per share, in the prior-year quarter. The company ended March 31, 2026 with $276.6 million in cash and cash equivalents and expects this to fund planned operating expenses into 2028.
Taysha Gene Therapies reported full-year 2025 results and a major update on its Rett syndrome program TSHA-102. Revenue was $9.8M versus $8.3M in 2024, while research and development expenses rose to $86.4M and general and administrative expenses to $33.9M.
The company recorded a net loss of $109.0M, or $0.34 per share, compared with a $89.3M loss, or $0.36 per share, a year earlier. Cash and cash equivalents were $319.8M as of December 31, 2025, and management expects current cash resources to fund operations into 2028.
Clinically, multiple Rett syndrome patients have been dosed in the REVEAL pivotal trial of TSHA-102, with dosing in the REVEAL and ASPIRE trials expected to complete in Q2 2026. The therapy has shown a favorable tolerability profile to March 2026, and Taysha reached written FDA alignment on its commercial manufacturing and comparability strategy to support a planned BLA submission.
Taysha Gene Therapies (TSHA) amended its at‑the‑market equity program, increasing the aggregate offering amount under its Sales Agreement to $212 million as of November 4, 2025, and terminating Leerink Partners as a sales agent.
Under the amended arrangement, Goldman Sachs & Co. LLC and Wells Fargo Securities, LLC remain as sales agents. Sales, if any, may be made from time to time as an “at the market offering” on the Nasdaq Global Select Market or other existing trading markets. The company is not obligated to sell shares.
As context, the company had previously sold common stock with an aggregate offering price of approximately $12 million under the program as of September 30, 2025.
Taysha Gene Therapies (TSHA) filed a current report stating it issued a press release titled “Taysha Gene Therapies Regains Full Rights to Lead TSHA-102 Program in Clinical Evaluation for the Treatment of Rett Syndrome.”
The press release, dated October 16, 2025, is furnished as Exhibit 99.1 and incorporated by reference. TSHA-102 is described as the company’s lead program under clinical evaluation for Rett syndrome. No additional terms or financial details are included in this excerpt.
Taysha Gene Therapies, Inc. filed a current report to let investors know it has issued a new press release about its lead Rett syndrome gene therapy candidate, TSHA-102. The press release, dated October 9, 2025, presents a supplemental data analysis from Part A of the REVEAL Phase 1/2 clinical trials in Rett syndrome, and the data were shared at the 54th Child Neurology Society Annual Meeting.
The full text of this press release is included as Exhibit 99.1 to the report and is incorporated by reference, meaning detailed clinical and scientific information is contained in that exhibit rather than in the body of the report itself.
Taysha Gene Therapies, Inc. reported that it issued a press release titled “Taysha Gene Therapies Announces FDA Breakthrough Therapy Designation and Provides Positive Regulatory Update on TSHA-102 in Rett Syndrome.” The company states that the U.S. Food and Drug Administration granted Breakthrough Therapy designation for TSHA-102, its investigational therapy for Rett syndrome, and that it has received a positive regulatory update on this program. The full details are provided in the press release attached as Exhibit 99.1.
Taysha Gene Therapies disclosed that it furnished a press release reporting financial results and business highlights for the quarter ended June 30, 2025. The filing states the press release is included as Exhibit 99.1 and that the cover page interactive XBRL file is provided as Exhibit 104. The company notes the information in Item 2.02 (including Exhibit 99.1) is being furnished and is not deemed "filed" for purposes of Section 18 of the Exchange Act.
This report identifies the exhibits attached but does not present the detailed financial figures within the body of the 8-K itself; investors should consult Exhibit 99.1 for the full results and disclosures.