TSHA-102 granted Breakthrough Therapy designation by FDA Finalized FDA alignment on REVEAL pivotal trial protocol and SAP, including 6-month interim analysis that may expedite BLA submission, which was enabled by the rigorous developmental milestone evaluation in Part A REVEAL Phase 1/2 trials showing an unprecedented response rate Dosing of first patient in REVEAL pivotal trial scheduled for Q4 2025, with enrollment of... Read More

DALLAS, Oct. 28, 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 third quarter ended September 30, 2025, and host a corporate update... Read More

The 2022 Option Agreement between Astellas and Taysha has expired Regaining full rights to TSHA-102 Rett syndrome program enables Taysha to focus on driving its long-term value with full strategic flexibility and optionality TSHA-102 has demonstrated compelling Part A REVEAL Phase 1/2 safety and efficacy data, received FDA Breakthrough Therapy designation and is advancing with a clear path to potential registration Dosing of... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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 High dose and low dose TSHA-102 continue to be generally well tolerated with no treatment-related SAEs or DLTs in the 12 patients treated in Part A of REVEAL Phase 1/2... Read More

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... Read More

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... Read More

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,... Read More

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,... Read More

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 Caregiver research regarding gain/regain of developmental milestones supporting alignment with FDA on primary endpoint in the pivotal Part B trial of TSHA-102 Previously disclosed preclinical data supporting broad biodistribution across brain and spinal... Read More

DALLAS, May 28, 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 pricing of an underwritten public offering of 46,868,687 shares of its common stock at a price to the public of $2.75 per... Read More

DALLAS, May 28, 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 has commenced an underwritten public offering of shares of its common stock and, in lieu of common stock to certain... Read More

Natural history data analysis established patients ≥ six years of age are in developmental plateau, with a ~0% likelihood of gaining/regaining developmental milestones across the core functional domains of Rett syndrome Written alignment from FDA supports single-arm, open label pivotal trial with primary endpoint of developmental milestone gain/regain in the developmental plateau population (≥ 6 years, intend N=15) with each... Read More

Obtained written alignment from the FDA on key elements of TSHA-102 pivotal Part B trial design and next steps on enabling study initiation The FDA advised the Company to submit pivotal Part B trial protocol and associated statistical analysis plan as an amendment to the IND application, eliminating the need for formal end-of-phase meeting and potentially expediting study initiation and registration; IND amendment submission... Read More

DALLAS, May 08, 2025 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), 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 first quarter ended March 31, 2025, and host a corporate update conference call and webcast on... Read More

DALLAS, May 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 that, on May 1, 2025, the Compensation Committee of Taysha's Board of Directors granted one new employee an option to... Read More

DALLAS, April 04, 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 April 1, 2025, the Compensation Committee of Taysha's Board of Directors granted five new employees, in the... Read More

DALLAS, March 07, 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 March 3, 2025, the Compensation Committee of Taysha's Board of Directors granted three new employees, in the... Read More

High dose and low dose of TSHA-102 continue to be generally well tolerated with no treatment-related SAEs or DLTs in all pediatric, adolescent and adult patients treated (high dose, n=6; low dose, n=4) across both REVEAL trials as of February 2025 data cutoff Completed dosing of the 10 patients in Part A of both REVEAL trials; maturing dataset continues to support advancement toward pivotal Part B trial Productive ongoing... Read More

DALLAS, Feb. 19, 2025 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), 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 full-year ended December 31, 2024, and host a corporate update conference call and webcast on... Read More

DALLAS, Feb. 07, 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 February 3, 2025, the Compensation Committee of Taysha's Board of Directors granted three new employees, in the... Read More

DALLAS, Jan. 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 January 2, 2025, the Compensation Committee of Taysha's Board of Directors granted one new employee an option to... Read More

DALLAS, Dec. 06, 2024 (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 December 2, 2024, the Compensation Committee of Taysha's Board of Directors granted one new employee an option to... Read More

High dose TSHA-102 was generally well tolerated with no SAEs or DLTs in two adolescent/adult patients and one pediatric patient as of data cutoff; IDMC approved continued enrollment in cohort two (high dose) across both REVEAL trials; eight patients dosed to date (low dose=4, high dose=4) Advanced discussions with the FDA on trial design, endpoints and potential use of established natural history dataset for Part B of REVEAL... Read More

DALLAS, Nov. 06, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), 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 third quarter ended September 30, 2024, and host a corporate update conference call and webcast on... Read More

DALLAS, Nov. 01, 2024 (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 November 1, 2024, the Compensation Committee of Taysha's Board of Directors granted three new employees, in the... Read More

Data from an analysis of five NHP studies showed lumbar IT administration led to widespread and consistent biodistribution of AAV9 gene therapy vectors across brain and spinal cord regions IT and ICM administration achieved comparable biodistribution across brain and spinal cord regions in NHPs Findings from the analysis reaffirm the clinical potential of IT administration as an effective, safe and minimally invasive... Read More

DALLAS, Oct. 04, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), 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, 2024, the Compensation Committee of Taysha's Board of Directors granted one new employee an option to purchase 501,600 shares of... Read More

DALLAS, Sept. 26, 2024 (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 present previously disclosed clinical data on its TSHA-102 program in evaluation for Rett syndrome during an... Read More

DALLAS, Sept. 06, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), 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 3, 2024, the Compensation Committee of Taysha's Board of Directors granted one new employee an option to purchase 311,000 shares... Read More

Presented cohort one (low dose) data from both trials of TSHA-102 at 2024 IRSF Rett Syndrome Scientific Meeting that demonstrated durable improvements across consistent clinical domains and an encouraging safety profile in adult (up to 52 weeks) and pediatric (up to 22 weeks) patients TSHA-102 was generally well tolerated with no SAEs or DLTs as of initial six-week assessment in first patient in cohort two (high dose) of... Read More

DALLAS, Aug. 05, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), 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, 2024, and host a corporate update conference call and webcast on... Read More

DALLAS, Aug. 02, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), 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, 2024, the Compensation Committee of Taysha's Board of Directors granted two new employees, in the aggregate, options to purchase... Read More

DALLAS, July 05, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), 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 3, 2024, the Compensation Committee of Taysha's Board of Directors granted four new employees, in the aggregate, options to purchase... Read More

DALLAS, June 26, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), 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 pricing of an underwritten public offering of 14,361,113 shares of its common stock at a price to the public of $2.25 per share and, in lieu of... Read More

DALLAS, June 25, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), 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 has commenced an underwritten public offering of up to $75 million of shares of its common stock and, in lieu of common stock to certain... Read More

Durable improvements across consistent clinical domains in both adult and pediatric patients, including motor skills, communication/socialization, autonomic function, seizures, and an encouraging safety profile seen across adult (up to 52 weeks) and pediatric (up to 22 weeks) patients with different genetic mutation severity Longer-term data from both adult patients showed sustained and new improvements across multiple... Read More

Company to host webcast on Tuesday, June 18, 2024, at 8:00 AM Eastern Time Oral presentation by Elsa Rossignol, M.D., FRCP, FAAP, Principal Investigator of the REVEAL adolescent and adult trial at CHU Sainte-Justine and Colleen Buhrfiend, M.D., of RUSH University Medical Center at the 2024 IRSF Rett Syndrome Scientific Meeting on Wednesday, June 19, 2024, at 11:00 AM Mountain Time DALLAS, June 12, 2024 (GLOBE NEWSWIRE) --... Read More

DALLAS, June 07, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), 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 3, 2024, the Compensation Committee of Taysha's Board of Directors granted three new employees, in the aggregate, options to purchase... Read More

Completed dosing in cohort one (low dose, 5.7x10 14 total vg) of REVEAL Phase 1/2 adolescent and adult trial with longer-term data supporting the safety profile and durable response of TSHA-102; enrolled first patient in cohort two (high dose, 1x10 15 total vg) with dosing scheduled for Q2 2024 Dosed second pediatric patient in cohort one (low dose, 5.7x10 14 total vg) of REVEAL Phase 1/2 pediatric trial in Q1 2024 FDA... Read More

DALLAS, May 07, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of severe monogenic diseases of the central nervous system (CNS), today announced that it will report its financial results for the first quarter ended March 31, 2024, and host a corporate update conference call and... Read More

DALLAS, May 03, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of severe monogenic diseases of the central nervous system (CNS), today announced that, on May 1, 2024, the Compensation Committee of Taysha's Board of Directors granted four new employees, in the aggregate, options to... Read More

RMAT designation follows FDA’s review of available safety and efficacy data from the first three patients dosed with the low dose of TSHA-102 across both REVEAL Phase 1/2 trials (adolescent/adult and pediatric) RMAT designation enables increased dialogue with the FDA to support the potential expedited development and review of TSHA-102 in clinical evaluation for Rett syndrome DALLAS, May 02, 2024 (GLOBE NEWSWIRE) -- Taysha... Read More

DALLAS, April 05, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of severe monogenic diseases of the central nervous system (CNS), today announced that, on April 1, 2024, the Compensation Committee of Taysha's Board of Directors granted three new employees, in the aggregate, options... Read More

Data from first adult patient in REVEAL Phase 1/2 trial showed TSHA-102 (low dose, 5.7x10 14 total vg) was well-tolerated with no treatment-emergent SAEs as of 35-week assessment, with sustained improvement across key efficacy measures at decreased steroid levels and new improvement in RSBQ at month six Data from second adult... Read More

DALLAS, March 14, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha or the Company), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of severe monogenic diseases of the central nervous system (CNS), today announced that it will report its financial results for the full-year ended December 31, 2023, provide corporate and... Read More

DALLAS, March 01, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of severe monogenic diseases of the central nervous system (CNS), today announced that, on March 1, 2024, the Compensation Committee of Taysha's Board of Directors granted four new employees, in the aggregate, options... Read More

REVEAL adolescent and adult trial will proceed to high dose cohort following Independent Data Monitoring Committee approval of Company’s request to initiate dose escalation; dosing of first patient in cohort two (high dose, n=3) expected in Q2 2024 REVEAL adolescent and adult trial will now expand into the U.S. following submission to FDA (age 12+ protocol) Dosing of second patient in cohort one (low dose) of REVEAL... Read More

DALLAS, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (“Taysha” or “the Company”), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS), today provided an update on its deprioritized pipeline programs as part of an ongoing effort to help support their further potential... Read More

DALLAS, Feb. 02, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS), today announced that, on February 1, 2024, the Compensation Committee of Taysha's Board of Directors granted two new employees, in the aggregate, options to... Read More

DALLAS, Jan. 22, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS), today announced that it will present clinical data on its TSHA-102 program in evaluation for Rett syndrome during an oral poster presentation at the upcoming... Read More

Initiation of REVEAL pediatric trial in the U.S. broadens the clinical evaluation of TSHA-102 to female patients 5-8 years old with stage three Rett syndrome MHRA authorized the CTA for TSHA-102 in pediatric patients with Rett syndrome, enabling expansion of ongoing U.S. REVEAL pediatric trial into the U.K. TSHA-102 clinical program now includes broad evaluation across pediatric, adolescent and adult patients in three... Read More

DALLAS, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS), today announced that, on January 2, 2024, Taysha's Board of Directors granted Meredith Schultz, M.D., M.S., an option to purchase 257,700 shares of the... Read More

PHOENIX , Dec. 19, 2023 /PRNewswire/ -- Trinity Capital Inc. (NASDAQ: TRIN) ("Trinity"), a leading provider of diversified financial solutions to growth-stage companies, today announced the commitment of $40 million in term loans to Taysha Gene Therapies, Inc. (NASDAQ: TSHA) ("Taysha"), a clinical-stage gene therapy company, pursuant to a Loan and Security Agreement dated November 13, 2023 , by and among Taysha, the lenders... Read More

Health Canada authorized the Company’s protocol amendment that expands eligibility to include patients aged 12 and older with stage four Rett syndrome in the REVEAL Phase 1/2 adult trial in Canada Protocol amendment broadens TSHA-102 treatment potential to both adolescent and adult patients with Rett syndrome Dosing of the third patient in the REVEAL Phase 1/2 adult trial (age 12+ protocol) and completion of cohort one (low... Read More

Data from first adult patient in REVEAL Phase 1/2 trial showed TSHA-102 was well-tolerated with no treatment-emergent SAEs as of 20-week assessment with sustained improvement across key efficacy measures and new improvement in R-MBA, PGI-I and hand function, a hallmark characteristic of Rett syndrome at week 12 Data from second adult patient showed TSHA-102 was well-tolerated with no treatment-emergent SAEs as of six-week... Read More

DALLAS, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS), today announced that it will report its financial results for the third quarter ended September 30, 2023, and host a corporate update conference call and... Read More

In vitro data demonstrated the miRARE control element downregulates MECP2 transgene and protein expression in response to cellular levels of MeCP2 in cell culture models Data recapitulate in vivo findings in neonatal mice demonstrating TSHA-102 regulated MeCP2 expression in deficient CNS cells and avoided toxic overexpression in cells already expressing MeCP2 Available clinical data from the two adult patients dosed with... Read More

DALLAS, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS), today announced that it will present data on its TSHA-102 program in evaluation for Rett syndrome during two poster presentations at the European Society of... Read More

Available clinical data from the two adult patients dosed with TSHA-102 in the first cohort (low dose) to be discussed during upcoming quarterly earnings call following Independent Data Monitoring Committee (IDMC) review Dosing of third adult patient and completion of enrollment in the low-dose cohort expected in the fourth quarter of 2023 Dosing of first pediatric Rett syndrome patient expected in the first quarter of 2024... Read More

Following Type C meeting feedback from the U.S. FDA, Taysha is discontinuing development of TSHA-120 in GAN due to challenges with study design feasibility for potential Biologics License Application (BLA) submission Taysha will pursue external strategic options for the TSHA-120 program to potentially enable further program development Strategic program prioritization will reduce operating expenses and is anticipated to... Read More

Fast Track Designation (FTD) is designed to accelerate the development and expedite the review of therapies with potential to address unmet medical needs for a serious or life-threatening condition TSHA-102 has also received Orphan Drug and Rare Pediatric Disease designations from the United States (U.S.) Food and Drug Administration (FDA) and has been granted Orphan Drug designation from the European Commission DALLAS, Aug.... Read More

Data from first adult patient dosed in REVEAL Phase 1/2 trial showed TSHA-102 was well-tolerated with no treatment-emergent serious adverse events (SAEs) as of six-week assessment and improvement in key efficacy measures, including Clinical Global Impression – Improvement (CGI-I), Clinical Global Impression – Severity (CGI-S) and Rett Syndrome Behavior Questionnaire (RSBQ), four weeks post-treatment Principal Investigator... Read More

Financing led by RA Capital Management with participation from new and existing investors Expected net proceeds, along with existing cash and cash equivalents, are expected to extend cash runway into the third quarter of 2025 DALLAS, Aug. 14, 2023 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the... Read More

Independent Data Monitoring Committee recommended REVEAL Phase 1/2 trial continuation and proceeding with dosing of second patient based on encouraging initial clinical data from the first adult with Rett syndrome dosed with investigational gene therapy TSHA-102 Initial clinical update from the first patient dosed with TSHA-102 planned for forthcoming quarterly earnings call Dosing of second patient expected in the third... Read More

Company views that results of comprehensive data analysis of TSHA-120 and development of disease progression model (DPM) address U.S. Food and Drug Administration (FDA) feedback regarding the effort-dependent nature of MFM32 as primary endpoint in an unblinded study and heterogeneity of GAN; Taysha plans to review potential regulatory pathway for TSHA-120 at a formal meeting with the FDA expected in Q3 2023 New GAN analysis... Read More

Virtual R&D Day featuring collaborator Salman Bhai, MD, and Taysha’s leadership team at 10:00 AM ET on June 28, 2023 Company to provide update on new data analyses for TSHA-120 in GAN, and initial safety observations for TSHA-102 in Rett syndrome DALLAS, June 15, 2023 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene... Read More

The Phase 1/2 REVEAL trial is a first-in-human, randomized, dose-escalation and dose-expansion study evaluating the safety and preliminary efficacy of TSHA-102 in adults with Rett syndrome TSHA-102 utilizes novel miRARE technology, designed to regulate cellular MECP2 levels Initial available clinical safety data from Phase 1/2 REVEAL trial will be reported at Taysha’s upcoming R&D Day on June 28, 2023, at 10:00 AM Eastern... Read More

New preclinical data after neonatal administration in wild-type mice showed no detectable impact on survival, neurobehavioral functions and overall health, suggesting TSHA-102, engineered with novel miRARE technology, avoided toxic overexpression of MeCP2 within cells already expressing MeCP2 Data reinforce previous findings in Mecp2 –/Y knockout mice demonstrating TSHA-102 regulated cellular MeCP2 levels and significantly... Read More

Screening completed and dosing scheduled for first potential subject in the Phase 1/2 REVEAL trial in Rett syndrome; dosing of first adult patient with TSHA-102 expected in Q2 2023; initial available Phase 1/2 clinical data, primarily on safety, expected in Q2 2023 Clinical Trial Application (CTA) submission to United Kingdom (UK) MHRA for TSHA-102 in pediatric patients with Rett syndrome expected in mid-2023;... Read More

DALLAS, May 04, 2023 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS), today announced that it will report its financial results for the first quarter ended March 31, 2023, and host a corporate update conference call and webcast on... Read More

DALLAS, April 27, 2023 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system (CNS), today announced that an abstract related to its TSHA-102 program in Rett syndrome was accepted for presentation at the upcoming American Society of Gene and... Read More

Initiated screening of first potential subject in Phase 1/2 REVEAL trial in Rett syndrome; dosing of first adult patient with TSHA-102 expected in H1 2023; submitted protocol amendment to allow for younger patients; initial available Phase 1/2 clinical data, primarily on safety, expected in H1 2023 Clinical Trial Application (CTA) submission to United Kingdom (UK) MHRA for TSHA-102 in pediatric patients with Rett syndrome... Read More

DALLAS, March 15, 2023 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric, clinical-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic rare diseases of the central nervous system (CNS), today announced that it will report its financial results for the fourth quarter and full-year ended December 31, 2022, and host a... Read More

Type B end-of-Phase 2 meeting with U.S. Food and Drug Administration (FDA) provided additional clarity for TSHA-120 for the treatment of giant axonal neuropathy (GAN) ultra-rare disease program - FDA acknowledged MFM32 as an acceptable endpoint with a recommendation to dose additional patients in a double-blind, placebo-controlled design to support Biologics License Application (BLA) submission Organizational and business... Read More

Chair of the Board of Directors, Sean P. Nolan, appointed Chief Executive Officer Board Director, Sukumar Nagendran, M.D., appointed President and Head of R&D DALLAS, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Taysha Gene Therapies, Inc. (Nasdaq: TSHA), a patient-centric, pivotal-stage gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous... Read More