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Taysha Gene Therapies, Inc. (Nasdaq: TSHA) is a pioneering clinical-stage biotechnology company headquartered in Dallas, Texas. Founded in 2019, Taysha is dedicated to developing and commercializing transformative gene therapies using adeno-associated viruses (AAV) to treat severe monogenic diseases of the central nervous system (CNS).
Taysha focuses on eradicating monogenic CNS diseases, addressing severe unmet medical needs, and dramatically improving the lives of patients and their caregivers. With a robust pipeline, including leading clinical program TSHA-102, the company aims to develop curative medicines. TSHA-102, currently in clinical evaluation for Rett syndrome, employs miRNA-Responsive Auto-Regulatory Element (miRARE) technology to deliver a functional MECP2 gene, aiming to mediate MECP2 levels in the CNS without the risk of overexpression.
Rett syndrome is a rare neurodevelopmental disorder caused by mutations in the MECP2 gene, leading to severe intellectual disabilities and various neurological impairments. TSHA-102 has received multiple designations, including Fast Track, Orphan Drug, and Rare Pediatric Disease from the FDA, and Orphan Drug designation from the European Commission, underscoring its potential to address significant medical needs.
Taysha has also made strategic advances with its partnerships, particularly with the University of Texas Southwestern Medical Center. This collaboration focuses on developing and commercializing AAV-based gene therapies, leveraging Taysha's integrated platform and the university's Gene Therapy Program.
Recently, Taysha achieved numerous milestones, including significant updates to the TSHA-102 program. The Independent Data Monitoring Committee (IDMC) approved dose escalation in the REVEAL Phase 1/2 trials, indicating promising initial safety and efficacy data. Taysha also expanded these trials into the United States, enhancing their ability to evaluate TSHA-102 across broader patient demographics.
Furthermore, Taysha terminated an existing loan agreement and entered a new one to facilitate the transfer of intellectual property (IP) for several programs to third parties. This strategic move extended their cash runway into 2026, demonstrating financial prudence and long-term planning.
The company is actively progressing clinical trials for TSHA-102, including both adolescent/adult and pediatric cohorts, which are crucial for regulatory and clinical development. Taysha's focus on innovative gene therapy solutions, combined with a patient-centric approach, positions it as a significant player in the biotech landscape.
For continuous updates and detailed information, visit the company’s website at www.tayshagtx.com.
Taysha Gene Therapies (Nasdaq: TSHA) announced participation in two fireside chats at the Oppenheimer 32nd Annual Virtual Healthcare Conference. The first chat, focusing on AAV-based Gene Therapy, will take place on
Taysha Gene Therapies (TSHA) announced promising clinical safety data for its gene therapy targeted at CLN7 Batten disease, presented at the 18th Annual WORLD Symposium. The trial achieved the highest intrathecal dose ever delivered in humans, demonstrating a favorable safety profile with no adverse immune responses or dorsal root ganglia inflammation. The trial, ongoing at UT Southwestern, aims to establish safety and tolerability, with potential implications for a serious, currently untreated disease affecting approximately 4,000 patients globally.
Taysha Gene Therapies, Inc. (Nasdaq: TSHA) has reported promising clinical findings for its gene therapy TSHA-120, aimed at treating giant axonal neuropathy (GAN). The data revealed a clinically significant improvement in MFM32 scores across all therapeutic cohorts after one and three years. Specifically, the high dose cohort showed a 5-point improvement compared to an 8-point decline in natural history by Year 1. Additionally, nerve regeneration was confirmed in biopsies. TSHA-120 demonstrated a favorable safety profile over 53 patient-years.
Taysha Gene Therapies (TSHA) reported positive initial data for TSHA-101, a gene therapy for GM2 gangliosidosis. Patient 1 with Sandhoff disease achieved Hex A enzyme activity at 190% of normal by Month 1 and 288% by Month 3, translating to 58-fold above the asymptomatic level. Patient 2 with Tay-Sachs saw a 5-fold increase at Month 1. This is the first support for a bicistronic vector in humans, aiming to normalize enzyme activity. The therapy was well-tolerated, with further clinical updates expected by year-end.
Taysha Gene Therapies (Nasdaq: TSHA) has announced that RA Session II, its President and CEO, will present a corporate overview at the 40th Annual J.P. Morgan Healthcare Conference on January 13, 2022, at 9:00 AM ET. The presentation will focus on Taysha's mission to develop AAV-based gene therapies aimed at treating monogenic diseases of the central nervous system. A webcast of the presentation will be accessible in the 'Events & Media' section of Taysha's website, with archived access available for 60 days.
Taysha Gene Therapies, Inc. (Nasdaq: TSHA) announces participation of RA Session II, President and CEO, in two panels at the LifeSci Partners 11th Annual Corporate Access Event on January 6, 2022. The first panel, titled Gene Therapy: Reaching its Full Potential, occurs at 11:00 AM ET, while the second, Patient Advocacy: Honing the Skill for Crossover Communications, takes place at 2:00 PM ET. Viewers can access the webcasts through the company's website, which also offers archived versions for 60 days.
Taysha Gene Therapies (NASDAQ: TSHA) announced plans for clinical data updates in January 2022, focusing on TSHA-101 for GM2 gangliosidosis and TSHA-120 for giant axonal neuropathy (GAN). The virtual investor calls will cover preliminary clinical safety data and enzyme activity for TSHA-101, as well as safety and efficacy results for the highest dose of TSHA-120. Taysha aims to discuss the program's status, potential regulatory strategies, and commercialization efforts to improve the lives of patients with monogenic CNS diseases.
Taysha Gene Therapies (NASDAQ: TSHA) has been added to the ICE Biotechnology Index (NYSE: ICEBIO), effective December 20, 2021. This inclusion recognizes its value and platform in the biotechnology sector, focusing on gene therapies for central nervous system disorders. CEO RA Session II emphasized the importance of this validation as the company works towards clinical and regulatory milestones to enhance visibility within the investment community. The ICE Biotechnology Index tracks U.S.-listed biotech companies engaged in therapeutic research and development.
Taysha Gene Therapies (TSHA) reported preliminary clinical safety data for its first-generation CLN7 construct, demonstrating a favorable safety profile with no major adverse events observed. The Data Safety Monitoring Board supported dose escalation to the highest dose of 1.0x1015 viral genomes in humans. Upcoming results will be presented at the 18th Annual WORLDSymposium in February 2022. Additionally, Taysha has designed a next-generation construct aimed at enhancing potency and manufacturability while reducing immunogenicity risks.
Taysha Gene Therapies (NASDAQ: TSHA) has initiated the clinical development of TSHA-118 for treating CLN1 disease, following a recently approved Clinical Trial Application. The first clinical site is Queen’s University in Ontario, Canada, under Dr. Jagdeep Wahlia. Preclinical studies show that TSHA-118 can significantly improve survival and behavior in models of CLN1 disease, with preliminary clinical safety and enzyme activity data expected in H1 2022. This gene therapy holds promise as a disease-modifying treatment for CLN1 disease, which affects approximately 1 in 138,000 live births globally.
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