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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, Inc. (Nasdaq: TSHA) has announced multi-year collaborations with Cleveland Clinic and UT Southwestern to develop next-generation mini-gene payloads for AAV gene therapies targeting genetic epilepsies and other CNS disorders. Taysha has secured exclusive options on new payloads and intellectual property from these partnerships. Researchers will create mini-gene payloads addressing limitations in AAV gene therapy, with the aim of expanding treatable genetic CNS diseases. These collaborations leverage the capabilities of leading institutions to address vector capacity challenges.
Taysha Gene Therapies (Nasdaq: TSHA) has outlined its strategic priorities and business outlook for 2021. The company has transitioned to a clinical-stage entity and expanded its leadership team. Key milestones include reporting clinical data for GM2 gangliosidosis, initiating multiple clinical trials, and submitting several IND/CTA applications within the year. Taysha plans to advance drug candidates TSHA-101, TSHA-118, TSHA-102, and TSHA-104, and develop its internal cGMP facility while increasing its workforce significantly. The company aims to leverage its innovative platform for sustained value creation in gene therapy.
Taysha Gene Therapies (Nasdaq: TSHA) has expanded its leadership team with the appointments of Timothy J. Douros as Chief Legal Officer and Tracy M. Porter as Chief People Officer. Douros, with over 25 years in biotech law, comes from Bluebird Bio, bringing vital legal expertise in gene therapy development. Porter, with nearly 30 years in HR, previously led HR at Audentes Therapeutics and will enhance Taysha's talent acquisition and organizational growth. The company remains focused on developing innovative AAV-based gene therapies for monogenic CNS diseases.
Taysha Gene Therapies (Nasdaq: TSHA) announced that the FDA granted rare pediatric disease and orphan drug designations for TSHA-105, a gene therapy targeting SLC13A5-related epilepsy. This designation aims to expedite the development of therapies for serious conditions affecting children. SLC13A5 deficiency leads to severe epilepsy in infants, and the FDA's recognition highlights TSHA-105's potential as a therapeutic option. These designations bring benefits such as tax credits and market exclusivity, enhancing TSHA's prospects in drug development.
Taysha Gene Therapies (Nasdaq: TSHA) and UT Southwestern Medical Center have launched an innovation fund aimed at developing gene therapies for monogenic diseases affecting the central nervous system. This partnership will enhance UTSW's research capabilities and allow Taysha to have exclusive options on new programs and intellectual property. The collaboration has already produced 18 novel product candidates, including TSHA-101 and TSHA-118, which are now in clinical trials. The focus remains on accelerating the discovery of novel therapies to address unmet medical needs.
Taysha Gene Therapies (NASDAQ: TSHA) has announced a multi-year collaboration with AllStripes to advance TSHA-104, an AAV9-based gene therapy for SURF1-associated Leigh syndrome. The partnership will utilize AllStripes’ clinical database to enhance understanding of the disease's natural history and progression, targeting an Investigational New Drug application for 2021. TSHA-104 aims to address a critical unmet medical need, as there are currently no approved treatments for this severe neurological disorder, which typically presents in infancy and can be fatal within a few years.
Taysha Gene Therapies (Nasdaq: TSHA) has announced key leadership changes with the appointments of Greg Gara as Senior Vice President of Manufacturing and Kimberly Lee, D.O., as Senior Vice President of Corporate Communications and Investor Relations. Gara brings over 25 years of experience in biotechnology manufacturing, previously serving at Sarepta and AveXis. Dr. Lee offers over 20 years in corporate finance and communications, previously at Lexicon Pharmaceuticals. These appointments aim to enhance Taysha's mission to develop transformative gene therapies for central nervous system diseases.
Taysha Gene Therapies (Nasdaq: TSHA) announced that Queen’s University in Ontario has received Clinical Trial Application approval from Health Canada for the Phase 1/2 trial of TSHA-101, an AAV9-based gene therapy for infantile GM2 gangliosidosis. This trial marks TSHA-101 as the first bicistronic vector entering first-in-human studies. GM2 gangliosidosis is a fatal genetic disorder with no approved treatments, making this a pivotal moment for affected children.
Taysha Gene Therapies (Nasdaq: TSHA) has signed a lease for a 187,000-square-foot cGMP manufacturing facility in Durham, North Carolina. The company plans to invest $75 million and create 200 jobs over the next two and a half years. This facility will enhance their capabilities for producing gene therapies to meet clinical and commercial demand and is expected to be fully operational by 2023. Moreover, Taysha will receive up to $9.4 million in state and local incentives. This strategic move supports their growth plans and aims to accelerate the delivery of transformative treatments.
Taysha Gene Therapies (Nasdaq: TSHA) announced its inclusion in the Russell 2000® Index, effective December 21, 2020. This index measures the performance of small-cap U.S. equities and reflects approximately 10% of the total market capitalization of the Russell 3000® Index. With around $9 trillion in assets benchmarked against Russell indexes, this move is significant for Taysha as it enhances visibility among investors. The company focuses on developing AAV-based gene therapies for treating monogenic diseases of the central nervous system, aiming for rapid treatment translation from bench to bedside.
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