Taysha Gene Therapies, Inc.

Taysha Gene Therapies, Inc. announced that its Compensation Committee granted equity awards to one new employee on August 3, 2026. The awards include restricted stock units representing 144,000 shares and an option to purchase 92,400 shares of common stock. These grants were made under the 2023 Inducement Plan to incentivize the new hire, with both RSUs and stock options vesting over four years, subject to continued employment.

Taysha Gene Therapies, Inc. and Catalent, Inc. have announced a commercial supply agreement for TSHA-102, Taysha's investigational gene therapy for Rett syndrome. Under the agreement, Catalent will be the primary commercial manufacturer for TSHA-102 following potential FDA approval. This partnership secures long-term manufacturing capacity and a scalable supply framework, strengthening Taysha's commercial infrastructure and launch readiness for TSHA-102.

Taysha Gene Therapies, Inc. announced the pricing of an underwritten public offering to issue 32,500,001 shares of common stock and 833,333 pre-funded warrants. The offering price to the public is $6.00 per share and $5.999 per pre-funded warrant. The company expects to receive net proceeds of approximately $187.4 million, or $215.6 million if the underwriters fully exercise their option to purchase additional shares. These funds, combined with existing cash, are anticipated to extend the company's cash runway into the second half of 2028.

Taysha Gene Therapies announced multiple presentations highlighting its TSHA-102 program for Rett syndrome at the 2026 International Rett Syndrome Foundation (IRSF) Rett Syndrome Scientific Meeting. The presentations include longer-term REVEAL Part A data demonstrating broad, multi-domain functional impact that deepened over time. New data also supports the developmental milestone assessment (DMA) as a valid, FDA-supported primary endpoint for interventional studies, and preclinical data showed superior MeCP2 expression.

Taysha Gene Therapies, a clinical-stage biotechnology company, announced the commencement of an underwritten public offering to raise $200.0 million. The offering includes common stock and pre-funded warrants, with an option for underwriters to purchase an additional 15% of shares. The offering is subject to market conditions and will be made via a prospectus supplement and accompanying prospectus.

Taysha Gene Therapies announced the completion of dosing in its REVEAL pivotal trial for TSHA-102, an investigational gene therapy for Rett syndrome. The company also reported positive longer-term clinical data from Part A of the REVEAL Phase 1/2 trials, showing that 100% of patients achieved at least one developmental milestone by 12 months post-treatment, with an average of 26 functional gains per patient. TSHA-102 demonstrated a durable and deepening treatment effect and was generally well-tolerated. These robust results support a potential Biologics License Application (BLA) submission, with topline data and FDA feedback anticipated in the first half of 2027.

Taysha Gene Therapies announced that its Compensation Committee granted restricted stock units (RSUs) representing 714,700 shares and options to purchase 468,600 shares of common stock to four new employees. These inducement grants were made under the 2023 Inducement Plan, with RSUs vesting over four years and stock options vesting over four years at an exercise price of $5.97.

Taysha Gene Therapies reported a net loss of $(42.4) million for Q1 2026, a significant increase from $(21.5) million in Q1 2025, with revenue dropping to $0 from $2.3 million. Research and development expenses more than doubled to $33.8 million. The company ended the quarter with $276.6 million in cash and cash equivalents, which it expects to fund operations for at least 12 months. Additionally, the Astellas GAN and Rett options expired in October 2025, returning full rights to the TSHA-102 program to Taysha.

Taysha Gene Therapies reported its first quarter 2026 financial results and provided a corporate update, highlighting significant progress in its TSHA-102 program for Rett syndrome. The company reaffirmed FDA alignment on the BLA pathway for TSHA-102, including the potential for approval based on a six-month interim analysis of the REVEAL pivotal trial. While clinical development is advancing positively with dosing on track and a favorable tolerability profile, the company experienced increased research and development expenses and a higher net loss for the quarter.

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.