Recently disclosed clinical cohort data from high (1x1015 total vg) and low dose (5.7x1014 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 cord regions following lumbar intrathecal delivery of AAV9 gene therapy vectors in non-h ...

Group 1 - The article discusses Taysha Gene Therapies, Inc. (NASDAQ: TSHA) and its recent developments, particularly focusing on initial data related to Rett Syndrome and upcoming catalysts in 2024 [2]. - The author operates the Biotech Analysis Central service, which provides in-depth analysis of various pharmaceutical companies and includes a library of over 600 biotech investing articles [2]. - The service offers a model portfolio of more than 10 small and mid-cap stocks, along with live chat and analysis to assist healthcare investors in making informed decisions [2].

Taysha Gene Therapies Inc. TSHA on Wednesday announced details of its planned pivotal Part B trial design for TSHA-102 following written alignment from the U.S. Food and Drug Administration (FDA).Single-arm, open-label trial with patients serving as their control (intend N=15).Enrollment of females in the developmental plateau population of Rett syndrome (≥ 6 years).The primary endpoint will assess developmental milestone gain or regain.The safety of TSHA-102 will be evaluated in females in the pre-developm ...

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 patient serving as their own control 100% of patients in REVEAL Part A (N=10, 6-21 ...

Taysha Gene Therapies, Inc. (TSHA) came out with a quarterly loss of $0.08 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.10 per share a year ago. These figures are adjusted for non-recurring items.A quarter ago, it was expected that this company would post a loss of $0.08 per share when it actually produced a loss of $0.07, delivering a surprise of 12.50%.Over the last four quarters, the company has surpassed consensus EPS estimates two times.Taysha Gene Therapies, which b ...

Taysha Gene Therapies Inc (TSHA) Q1 2025 Earnings Call May 15, 2025 08:30 AM ET Company Participants Hayleigh Collins - Senior Director - Corporate Communications & Investor RelationsSean Nolan - CEO & ChairmanSukumar Nagendran - President & Head - Research & DevelopmentKamran Alam - Chief Financial OfficerWhitney Ijem - Managing DirectorMalcolm Hoffman - Senior BioPharma Equity Research Associate Conference Call Participants Kristen Kluska - AnalystLydia Erdman - Biotech Equity Research AnalystGil Blum - S ...

Taysha Gene Therapies Inc (TSHA) Q1 2025 Earnings Call May 15, 2025 08:30 AM ET Speaker0 Greetings, and welcome to the Tatia Gene Therapies First Quarter twenty twenty five Earnings Call. At this time, all participants are in listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Hayley Collins, Director, Head of Corporate Communications. Please go ahead. Speaker1 Thank ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-39536 Taysha Gene Therapies, Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware | 84- ...

Exhibit 99.1 Taysha Gene Therapies Reports First Quarter 2025 Financial Results and Provides Corporate Update 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 ...

High dose and low dose of TSHA-102 continue to be generally well tolerated with no treatment-related SAEs or DLTs in the pediatric, adolescent and adult patients treated (high dose, n=6; low dose, n=4) across both REVEAL trials as of April 10, 2025, data cutoff Program update on pivotal trial design, Rett syndrome natural history data analysis and clinical data from cohort two (high dose) and cohort one (low dose) of both REVEAL trials expected in Q2 2025 in conjunction with IRSF Rett Syndrome Scientific Me ...