Taysha Gene Therapies, Inc. Stock Price, News & Analysis

Taysha Gene Therapies (NASDAQ:TSHA) has received FDA Breakthrough Therapy designation for TSHA-102, its gene therapy treatment for Rett syndrome. The designation was granted based on clinical evidence from 12 patients in Part A of the REVEAL Phase 1/2 trials, showing a 100% response rate in developmental milestone achievement.

The company has also finalized FDA alignment on the REVEAL pivotal trial protocol and statistical analysis plan. Key elements include a 6-month interim analysis that could expedite BLA submission. The pivotal trial will evaluate 15 female patients aged 6-22 years, with a minimum success threshold of 33% response rate. Patient enrollment is scheduled to begin in Q4 2025.

Taysha Gene Therapies (Nasdaq: TSHA), a clinical-stage biotech company developing AAV-based gene therapies for CNS diseases, has granted stock options to five new employees. The Compensation Committee approved options to purchase 225,000 shares at an exercise price of $2.84 per share under the company's 2023 Inducement Plan.

The options have a 10-year term with a four-year vesting schedule: 25% vests after one year, followed by monthly vesting over 36 months. These grants were made in accordance with Nasdaq Listing Rule 5635(c)(4) as employment inducements.

Taysha Gene Therapies (NASDAQ: TSHA) reported significant progress in Q2 2025, highlighted by the commencement of site activation for their REVEAL pivotal trial for TSHA-102 in Rett syndrome treatment. The trial follows successful Phase 1/2 results showing a 100% response rate for the primary endpoint of developmental milestone gains.

The company significantly strengthened its financial position through a $230 million public offering, extending their cash runway into 2028. As of June 30, 2025, Taysha held $312.8 million in cash. Q2 2025 saw a net loss of $26.9 million ($0.09 per share), compared to $20.9 million in Q2 2024.

The REVEAL pivotal trial will enroll 15 females aged 6-22 years with Rett syndrome, with patient enrollment expected to begin in Q4 2025. Importantly, both high and low doses of TSHA-102 have shown favorable safety profiles with no treatment-related SAEs in 12 patients treated.

Taysha Gene Therapies (NASDAQ:TSHA), a clinical-stage biotech company specializing in AAV-based gene therapies for CNS diseases, will host its Q2 2025 financial results conference call on August 12, 2025, at 8:30 AM ET. The company will present its financial performance for the quarter ended June 30, 2025, along with a corporate update.

Investors can access the call via toll-free number (877-407-0792) or international line (201-689-8263) using conference ID 13754869. A webcast will also be available on the company's investor relations website.

Taysha Gene Therapies (Nasdaq: TSHA), a clinical-stage biotech company developing AAV-based gene therapies for CNS diseases, has granted a stock option to a new employee. The inducement grant includes options to purchase 90,000 shares at an exercise price of $2.63 per share under the company's 2023 Inducement Plan.

The stock option has a 10-year term with a four-year vesting schedule: 25% vesting after one year and the remaining 75% vesting monthly over the following 36 months, subject to continued employment.

Taysha Gene Therapies (Nasdaq: TSHA), a clinical-stage biotech company developing AAV-based gene therapies for CNS diseases, has granted stock options to two new employees. The Compensation Committee approved options to purchase 30,000 shares of common stock at an exercise price of $2.34 per share under the company's 2023 Inducement Plan.

The options have a 10-year term with a four-year vesting schedule: 25% vesting after one year and the remaining 75% vesting monthly over the following 36 months. The grants were made in accordance with Nasdaq Listing Rule 5635(c)(4) as employment inducements.

Taysha Gene Therapies (NASDAQ: TSHA), a clinical-stage biotech company specializing in AAV-based gene therapies for CNS diseases, has granted stock options to two new employees. The Compensation Committee approved options to purchase 401,000 shares of common stock under the company's 2023 Inducement Plan on June 2, 2025. The options have an exercise price of $2.785, matching the closing price on the grant date, with a 10-year term. The vesting schedule spans four years, with 25% vesting after the first year and the remaining 75% vesting monthly over the following 36 months, contingent on continued employment.

Taysha Gene Therapies (NASDAQ: TSHA) announced three oral presentations and a symposium at the 2025 IRSF Rett Syndrome Scientific Meeting in Boston from June 9-11, 2025. The presentations will cover clinical data from TSHA-102 trials, including high and low dose cohorts from REVEAL adolescent/adult and pediatric Phase 1/2 trials, caregiver research on developmental milestones, and preclinical data on AAV9 vector biodistribution. The company will also host a symposium on Rett syndrome natural history data findings. Dr. Sukumar Nagendran, President and Head of R&D, emphasized TSHA-102's potential to improve function and quality of life for Rett syndrome patients. The presentations align with FDA discussions on potential registration pathways and demonstrate the company's progress in developing gene therapy treatments for this severe CNS disorder.

Taysha Gene Therapies (NASDAQ: TSHA) has announced the pricing of a public offering, consisting of 46,868,687 shares of common stock at $2.75 per share and pre-funded warrants to purchase 25,858,586 shares at $2.749 per warrant. The company expects to raise approximately $200.0 million in gross proceeds before deducting expenses.

The underwriters have a 30-day option to purchase up to an additional 10,909,090 shares. The offering, led by joint book-running managers Jefferies, BofA Securities, Piper Sandler, and Barclays, is expected to close around May 30, 2025. Taysha is a clinical-stage biotechnology company developing AAV-based gene therapies for severe CNS monogenic diseases.