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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 a multi-year collaboration with Yale University to develop next-generation mini-gene payloads for AAV gene therapies targeting neurodevelopmental disorders. This partnership follows previous collaborations with Cleveland Clinic and UT Southwestern, focusing on overcoming challenges in gene therapy. Yale's researchers will create payloads aimed at treating disorders like intellectual disability, while UTSW will produce and evaluate the viral vector constructs. This initiative aims to expand the range of genetic diseases treatable by AAV-based therapies.
Taysha Gene Therapies, Inc. (Nasdaq: TSHA) reported its financial results for 2020, highlighting a net loss of $60 million or $3.40 per share, with R&D expenses at $31.9 million. The company successfully expanded its pipeline from 18 to 25 gene therapy candidates and anticipates significant clinical milestones in 2021, including initiating trials for TSHA-101, TSHA-102, and TSHA-104. Taysha raised approximately $307 million since inception, with $165.9 million net from its IPO, and aims to enhance its technologies and workforce throughout the year.
Taysha Gene Therapies, Inc. (Nasdaq: TSHA) announced it will report its financial results for the full year ended December 31, 2020, during a corporate update conference call on March 3, 2021, at 8:00 AM ET. The company focuses on developing AAV-based gene therapies for monogenic diseases of the central nervous system (CNS) and aims to translate treatments quickly from research to clinical applications. Taysha's collaboration with the UT Southwestern Gene Therapy Program enhances its pipeline targeting both rare and large patient populations.
Taysha Gene Therapies (Nasdaq: TSHA) announces its support for Rare Disease Day by launching the #RareAlly initiative, aimed at recognizing those in the rare disease community who provide inspiration and motivation. The initiative includes a photo submission campaign to raise funds for the rare disease community and an employee event with a guest speaker from the UT Southwestern Gene Therapy Program. Taysha emphasizes the collective efforts needed to advance treatment options for rare diseases, affecting approximately 300 million people globally.
Taysha Gene Therapies (Nasdaq: TSHA) has established an independent Scientific Advisory Board (SAB) to enhance its clinical development and commercialization efforts. This board comprises renowned experts in gene therapy and CNS diseases. CMO Suyash Prasad emphasized the board's potential to contribute significantly to the company’s AAV-based gene therapy pipeline. The SAB includes distinguished professionals like Deborah Bilder, Alan Boyd, Wendy K. Chung, David P. Dimmock, Michael W. Lawlor, and Gerald S. Lipshutz, each bringing extensive experience to the table.
Taysha Gene Therapies, Inc. (Nasdaq: TSHA) announces its participation in two upcoming virtual conferences: the Truist Fireside Chat on February 11, 2021, at 1:00 pm ET, and the 10th Annual SVB Leerink Global Healthcare Conference on February 26, 2021, at 8:40 am ET. Key participants include RA Session II, President and CEO, and Dr. Suyash Prasad, Chief Medical Officer. Audio webcasts will be accessible on Taysha's corporate website, with archived versions available for 60 days. Taysha focuses on developing gene therapies for central nervous system diseases, leveraging its integrated platform.
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.
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