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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 its participation in two upcoming conferences: the BTIG Biotechnology Conference on August 8, 2022, and the Wedbush PacGrow Healthcare Virtual Conference on August 10, 2022. At the BTIG conference, Suyash Prasad will discuss AAV Gene Therapies for CNS disorders. The Wedbush event will feature a panel on UltraOrphan diseases. Webcasts will be available on Taysha's website for 90 days post-event, highlighting the company's commitment to developing gene therapies for monogenic CNS diseases.
Taysha Gene Therapies (Nasdaq: TSHA) announced its participation in the William Blair Biotech Focus Conference 2022 on July 13, 2022. The company's President and CEO will join a panel discussion titled “AAV Gene Therapy: Delivery and Beyond” at 10:00 am ET. This event focuses on the company's mission to develop and commercialize innovative AAV-based gene therapies for treating monogenic central nervous system diseases. A webcast of the discussion will be available on Taysha's corporate website and archived for 60 days.
Taysha Gene Therapies (Nasdaq: TSHA) announces that its annual stockholder meeting will take place on June 17, 2022, at 10 am ET via webcast. The event aims to provide stockholders with updates on the company's progress in developing AAV-based gene therapies for monogenic diseases affecting the central nervous system. Interested parties can access the webcast through the Taysha corporate website. A copy of the 2021 annual report is also available online.
Taysha Gene Therapies (Nasdaq: TSHA) will participate in several upcoming healthcare conferences, including the Jefferies Healthcare Conference on June 8, Goldman Sachs 43rd Annual Global Healthcare Conference on June 14, BIO International Convention on June 15, and JMP Securities Life Sciences Conference on June 16. CEO RA Session II will join a panel discussion at the BIO International Convention, focusing on 'A New Era in Gene Therapy.' Webcasts will be available on the company's website for 90 days.
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.
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