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Taysha Gene Therapies(TSHA) - 2025 Q2 - Quarterly Report
2025-08-12 14:48
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 June 30, 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 | 84-3 ...
Taysha Gene Therapies(TSHA) - 2025 Q2 - Earnings Call Transcript
2025-08-12 13:30
Taysha Gene Therapies (TSHA) Q2 2025 Earnings Call August 12, 2025 08:30 AM ET Speaker0Ladies and gentlemen, good morning, and welcome to Tasia Gene Therapy's Second Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Haley Collins, Director, Head of Corporate Communications.Please go ...
Taysha Gene Therapies(TSHA) - 2025 Q2 - Quarterly Results
2025-08-12 12:10
Exhibit 99.1 Taysha Gene Therapies Reports Second Quarter 2025 Financial Results and Provides Corporate Update 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 P ...
Taysha Gene Therapies to Release Second Quarter 2025 Financial Results and Host Conference Call and Webcast on August 12
Globenewswire· 2025-08-05 20:05
Company Overview - Taysha Gene Therapies, Inc. is 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) [2] - The company's lead clinical program, TSHA-102, is in development for Rett syndrome, a rare neurodevelopmental disorder with no approved disease-modifying therapies [2] - Taysha aims to address severe unmet medical needs and improve the lives of patients and their caregivers through transformative medicines [2] Financial Results Announcement - Taysha Gene Therapies will report its financial results for the second quarter ended June 30, 2025, on August 12, 2025, at 8:30 AM Eastern Time [1] - A corporate update conference call and webcast will be hosted on the same date and time [1] Conference Call Details - The conference call will be held on Tuesday, August 12, at 8:30 AM Eastern Time / 7:30 AM Central Time [2] - Toll-free and international call-in numbers are provided for participants [2] - A webcast link is available for those who wish to join online [2]
Taysha Gene Therapies (TSHA) Moves to Buy: Rationale Behind the Upgrade
ZACKS· 2025-07-16 17:01
Investors might want to bet on Taysha Gene Therapies, Inc. (TSHA) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Since ...
Taysha Gene Therapies Announces Details for Oral Presentations at the 2025 IRSF Rett Syndrome Scientific Meeting Reviewing Recent Updates from the TSHA-102 Clinical Program
Globenewswire· 2025-06-03 21:17
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 ...
Taysha: TSHA-102 Presses On With IND Part B Protocol And SAP Amendments
Seeking Alpha· 2025-05-29 20:39
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].
Why Is Taysha Gene Therapies Stock Trading Higher On Thursday?
Benzinga· 2025-05-29 17:06
Core Insights - Taysha Gene Therapies Inc. announced details of its pivotal Part B trial design for TSHA-102 after receiving alignment from the FDA [1] - The company revealed clinical data from Part A of the REVEAL Phase 1/2 trials for TSHA-102 in treating Rett syndrome, a rare genetic disorder [2] Trial Design and Data - The pivotal Part B trial will include a single-arm, open-label design with an intended enrollment of 15 female patients aged 6 years and older [6] - The primary endpoint will assess the gain or regain of developmental milestones, while safety will be evaluated in a younger cohort aged 2-6 years [6] - The FDA advised the company to submit the trial protocol as an amendment to its IND application, streamlining the process [6] Clinical Efficacy - Efficacy data showed that 100% of patients gained at least one developmental milestone across key functional domains post-treatment with TSHA-102 [7] - A total of 22 developmental milestones were achieved among 10 patients, with significant early gains observed [7] - The high-dose cohort demonstrated a 100% responder rate 25% faster than the low-dose cohort, indicating accelerated functional benefits [7] Safety Profile - Both high and low doses of TSHA-102 were generally well tolerated, with no serious adverse events or dose-limiting toxicities reported [7] - All treatment-emergent adverse events related to TSHA-102 were mild to moderate in severity [7] Financial Activity - Taysha Gene Therapies priced an underwritten public offering of 46.9 million shares at $2.75 per share, raising $200 million in gross proceeds [4] - The company's stock saw a 9% increase, reaching $2.66 [5]
Taysha Gene Therapies Announces Pivotal Part B Trial Design Details for TSHA-102 in Rett Syndrome Enabled by IRSF Natural History Data and Positive Clinical Data from Part A of the REVEAL Adult/Adolescent and Pediatric Trials Evaluating TSHA-102
GlobeNewswire News Room· 2025-05-28 20:01
Core Insights - Taysha Gene Therapies announced positive clinical data for TSHA-102, a gene therapy for Rett syndrome, showing a 100% responder rate in patients aged 6-21 years, with all patients gaining or regaining at least one developmental milestone post-treatment [1][2][5] - The FDA has provided written alignment on the pivotal Part B trial design for TSHA-102, which is expected to begin in Q3 2025 [1][4][12] - The analysis of natural history data indicates that patients aged six years and older are in a developmental plateau, with a likelihood of gaining new milestones being exceedingly low without treatment [1][6] Company Overview - Taysha Gene Therapies is a clinical-stage biotechnology company focused on AAV-based gene therapies for severe monogenic diseases of the CNS, with TSHA-102 as its lead program targeting Rett syndrome [8][10] - TSHA-102 is designed as a one-time treatment that delivers a functional form of the MECP2 gene to address the genetic root cause of Rett syndrome [8][9] Clinical Trial Details - The pivotal Part B trial will be a single-arm, open-label study with an intended enrollment of 15 patients, assessing developmental milestone gain/regain [1][6] - The primary endpoint of the trial is the gain or regain of at least one defined developmental milestone, with independent central raters evaluating outcomes based on video evidence [6] - Safety data from the ongoing REVEAL Phase 1/2 trials indicated no treatment-related serious adverse events or dose-limiting toxicities [1][5][6] Efficacy and Safety Findings - In the REVEAL Part A trial, 100% of patients treated with TSHA-102 achieved developmental milestones, with high-dose cohorts showing faster and more pronounced improvements compared to low-dose cohorts [1][5][6] - Improvements were observed across multiple clinician-assessed outcome measures, including the Revised Motor Behavior Assessment and Clinician Global Impression – Improvement [6] Future Plans - The company plans to submit the pivotal trial protocol and statistical analysis plan as an amendment to the IND application within the current quarter [2][12] - Taysha anticipates initiating pivotal trial activities in Q3 2025, following FDA guidance [1][12]
Taysha Gene Therapies, Inc. (TSHA) Reports Q1 Loss, Tops Revenue Estimates
ZACKS· 2025-05-15 14:10
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 ...