Taysha Gene Therapies, Inc. (TSHA)

Previously disclosed 100% response rate across all 10 patients in Part A for pivotal trial primary endpoint of gain/regain of ≥ one natural history defined developmental milestone assessed via video-evidenced review by independent central raters New supplemental analysis of validated, structured efficacy scales provides supportive evidence of additional functional gains, with 100% of patients demonstrating multiple skill gains/improvements outside the natural history defined developmental milestones Findings reinforce the broad and consistent functional gains seen across the core domains that impact activities of daily living, with 22 developmental milestones and 165 additional skills/improvements achieved across the 10 patients post-TSHA-102 DALLAS, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha or the Company), a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today announced results from a new supplemental data analysis from Part A of the REVEAL Phase 1/2 adult/adolescent and pediatric trials evaluating TSHA-102 in females with Rett syndrome at the 54th Child Neurology Society (CNS) Annual Meeting. The analysis provides supportive evidence of additional functional gains in skills and improvements across core disease characteristics that are outside of the natural history defined developmental milestones, further highlighting the consistent, multi-domain impact of TSHA-102 on activities of daily living.

Taysha Gene Therapies, Inc.'s lead asset is TSHA-102. This is an intrathecal AAV9 gene therapy for Rett with a 100% Phase 1/2 responder rate and favorable safety. The FDA granted it a Breakthrough Therapy Designation. Its pivotal REVEAL trial finalized with a 6-month interim that could accelerate a BLA submission. The new trial uses objective, blinded, video-rated milestone gains. This will make the results easier to interpret and potentially support an accelerated BLA.

DALLAS, Oct. 03, 2025 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha or the Company), a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today announced that, on October 1, 2025, the Compensation Committee of Taysha's Board of Directors granted seven new employees, in the aggregate, options to purchase 1,289,600 shares of the Company's common stock in connection with their employment. The stock options were granted under the Taysha Gene Therapies, Inc. 2023 Inducement Plan as an inducement material to the individuals entering employment with Taysha in accordance with Nasdaq Listing Rule 5635(c)(4).

Breakthrough Therapy designation granted based on FDA's review of available clinical evidence of safety and efficacy from all 12 patients treated in Part A of the REVEAL Phase 1/2 trials Finalized FDA alignment on REVEAL pivotal trial protocol and SAP following resolution of remaining clinical and statistical queries to IND application amendment; on track to begin patient enrollment in Q4 2025 Key pivotal trial design elements remain unchanged, including 6-month interim analysis to potentially expedite BLA submission based on the rigorous developmental milestone evaluation in Part A showing an unprecedented response rate at 6 months post-TSHA-102 that deepened over time DALLAS, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha or the Company), a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to TSHA-102, an intrathecally delivered AAV9 gene therapy with disease modifying potential, for the treatment of Rett syndrome. Additionally, the Company announced that it has finalized alignment with the FDA on the REVEAL pivotal trial protocol and statistical analysis plan (SAP) that are intended to support the planned Biologics License Application (BLA) submission for TSHA-102, following the resolution of remaining clinical and statistical queries.

DALLAS, Sept. 05, 2025 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha or the Company), a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today announced that, on September 2, 2025, the Compensation Committee of Taysha's Board of Directors granted five new employees, in the aggregate, options to purchase 225,000 shares of the Company's common stock in connection with their employment. The stock options were granted under the Taysha Gene Therapies, Inc. 2023 Inducement Plan as an inducement material to the individuals entering employment with Taysha in accordance with Nasdaq Listing Rule 5635(c)(4).

Taysha Gene Therapies, Inc. (TSHA) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.07. This compares to a loss of $0.09 per share a year ago.

Taysha Gene Therapies, Inc. (NASDAQ:TSHA ) Q2 2025 Earnings Conference Call August 12, 2025 8:30 AM ET Company Participants Hayleigh Collins - Director of Corporate Communications & Investor Relations Kamran Alam - CFO & Corporate Secretary Sean P. Nolan - CEO & Chairman Sukumar Nagendran - President, Head of Research & Development and Director Conference Call Participants Biren N.

Commenced site activation for REVEAL pivotal trial in accordance with previously aligned upon key design elements, following receipt of No Objection Letter (NOL) from Health Canada and feedback from the FDA; patient enrollment anticipated to begin in Q4 2025

DALLAS, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha or the Company), a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today announced that it will report its financial results for the second quarter ended June 30, 2025, and host a corporate update conference call and webcast on Tuesday, August 12, 2025, at 8:30 AM Eastern Time.

Taysha Gene Therapies (TSHA) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

DALLAS, Aug. 01, 2025 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha or the Company), a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today announced that, on August 1, 2025, the Compensation Committee of Taysha's Board of Directors granted one new employee an option to purchase 90,000 shares of the Company's common stock in connection with their employment. The stock option was granted under the Taysha Gene Therapies, Inc. 2023 Inducement Plan as an inducement material to the individual entering employment with Taysha in accordance with Nasdaq Listing Rule 5635(c)(4).

Taysha Gene Therapies (TSHA) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

DALLAS, July 03, 2025 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha or the Company), a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today announced that, on July 1, 2025, the Compensation Committee of Taysha's Board of Directors granted two new employees, in the aggregate, options to purchase 30,000 shares of the Company's common stock in connection with their employment. The stock options were granted under the Taysha Gene Therapies, Inc. 2023 Inducement Plan as an inducement material to the individuals entering employment with Taysha in accordance with Nasdaq Listing Rule 5635(c)(4).

DALLAS, June 06, 2025 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha or the Company), a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today announced that, on June 2, 2025, the Compensation Committee of Taysha's Board of Directors granted two new employees, in the aggregate, options to purchase 401,000 shares of the Company's common stock in connection with their employment. The stock options were granted under the Taysha Gene Therapies, Inc. 2023 Inducement Plan as an inducement material to the individuals entering employment with Taysha in accordance with Nasdaq Listing Rule 5635(c)(4).

Recently disclosed clinical cohort data from high (1x10 15  total vg) and low dose (5.7x10 14  total vg) TSHA-102 from REVEAL adolescent/adult and pediatric Phase 1/2 trials

Taysha Gene Therapies, Inc. achieved positive updated data from Part A of the phase 1/2 REVEAL study using TSHA-102 to treat patients with Rett Syndrome. Alignment gained with FDA on IND amendments to be submitted to begin pivotal part B study of TSHA-102 for the treatment of patients with Rett Syndrome. The global market for Rett Syndrome in the 7 major markets is expected to reach $441.5 million by 2035.