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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 the initiation of clinical development for TSHA-102 targeting Rett Syndrome and received orphan drug designation for TSHA-120 for Giant Axonal Neuropathy (GAN). The company expects preliminary Phase 1/2 data for TSHA-102 by year-end 2022 and recently completed a GMP batch for TSHA-120. Financially, Taysha reported a net loss of $50.1 million for Q1 2022, up from $32.0 million year-over-year. Existing cash should fund operations into Q4 2023.
Taysha Gene Therapies, Inc. (Nasdaq: TSHA) will release its financial results for Q1 2022 on May 16, 2022, at 8 AM Eastern Time. The pivotal-stage gene therapy company focuses on AAV-based treatments for monogenic CNS diseases. Following the earnings call, investors will receive updates on the company's progress and pipeline. Interested participants can join the call by dialing 877-407-0792 (toll-free) or 201-689-8263 (international), with the conference ID 13729044. Further information is accessible through their webcast.
Taysha Gene Therapies (Nasdaq: TSHA) announced participation in the 25th Annual Meeting of the American Society of Gene & Cell Therapy in Washington, D.C., from May 16-19, 2022. The company will present oral and poster presentations featuring key gene therapy advancements aimed at treating monogenic diseases of the central nervous system. Notable presentations include the treatment approaches for Giant Axonal Neuropathy and Tauopathies. Additionally, Taysha will host a symposium discussing innovative strategies in gene therapy development.
Taysha Gene Therapies (Nasdaq: TSHA) announced the granting of orphan drug designation by the European Commission for TSHA-120, a gene therapy for giant axonal neuropathy (GAN). Clinical data shows a 10-point improvement in motor function by Year 3 compared to a natural decline of 24 points. Biopsy results indicate active nerve regeneration in patients. With 53 patient-years of safety data, TSHA-120 addresses a global patient population of 5,000 and offers a multi-billion dollar opportunity, as there are currently no approved treatments for GAN.
Taysha Gene Therapies (Nasdaq: TSHA) announced its participation in two upcoming events: the International Rett Syndrome Foundation (IRSF) Rett Syndrome Scientific Symposium and the ASCEND Rett Syndrome National Summit, both in Nashville, Tennessee, from April 26 to 30, 2022. Key presentations will include safety assessments of a miniMECP2 AAV9 vector for gene therapy and insights on caregiver perspectives. Taysha emphasizes its commitment to developing AAV-based gene therapies for monogenic CNS diseases, aiming to innovate treatments for both rare and common conditions.
Taysha Gene Therapies (Nasdaq: TSHA) announced its participation in the Chardan Genetic Medicines and Cell Therapy Manufacturing Summit on April 25, 2022. Key executives, including the CEO, CTO, and CMO, will join a panel discussion at 12:00 pm ET focusing on AAV gene therapy manufacturing standards from registration-targeted trials. Following this, a fireside chat will take place at 1:00 pm ET. Taysha is committed to developing AAV-based gene therapies for central nervous system diseases, aiming to translate research into effective treatments.
Taysha Gene Therapies (TSHA) reported significant changes in its strategic focus, prioritizing programs for giant axonal neuropathy (GAN) and Rett syndrome, affecting 5,000 and 350,000 patients respectively. A workforce reduction of 35% aims to enhance operational efficiency as clinical activities for other programs will be paused. Financial results show a net loss of $174.5 million for 2021 and R&D expenses increased by $100 million. Despite challenges, existing cash and financing are expected to extend the cash runway into Q4 2023.
Taysha Gene Therapies has announced the initiation of clinical development for TSHA-102, a gene therapy for Rett syndrome, following approval of the Clinical Trial Application by Health Canada. TSHA-102, utilizing the novel miRARE platform, aims to regulate transgene expression safely. Promising preclinical results were reported, showing improved survival and function in mouse models and a favorable safety profile in non-human primates. Preliminary clinical data are expected by the end of 2022, marking a significant milestone in treating this severe neurodevelopmental disorder affecting over 350,000 patients globally.
Taysha Gene Therapies (Nasdaq: TSHA) has announced plans to report its financial results for the fourth quarter and full year ending December 31, 2021. A corporate update conference call is scheduled for Thursday, March 31, 2022, at 8:00 AM Eastern Time. The company is focused on developing AAV-based gene therapies for treating monogenic diseases in the central nervous system. Taysha combines expertise in drug development with the UT Southwestern Gene Therapy Program to create a robust pipeline aimed at curing these diseases.
Taysha Gene Therapies (Nasdaq: TSHA) will participate in the Guggenheim Genomic Medicines and Rare Disease Day Conference on April 1, 2022, at 4:00 PM ET, and the 21st Annual Needham Virtual Healthcare Conference on April 11, 2022, at 11:45 AM ET. The events will feature discussions led by key executives including RA Session II, Suyash Prasad, and Kamran Alam. Taysha focuses on developing AAV-based gene therapies aimed at curing monogenic diseases of the CNS.
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