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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 been officially included in the Nasdaq Biotechnology Index effective December 20, 2021. This inclusion aims to enhance the company's visibility and attract investors as it continues to advance its AAV-based gene therapy pipeline focused on treating monogenic diseases of the CNS. The Nasdaq Biotechnology Index tracks biotechnology and pharmaceutical securities that meet specific eligibility criteria, reflecting Taysha's commitment to developing curative treatments for patients.
Taysha Gene Therapies (NASDAQ: TSHA) presented promising preclinical data for TSHA-105 at the American Epilepsy Society Annual Meeting on December 6, 2021. The AAV9-based gene therapy showed the ability to normalize electroencephalogram (EEG) and citrate levels, improving survival rates in mouse models with SLC13A5 deficiency. No adverse effects were noted following cerebrospinal fluid delivery. The therapy received orphan drug designation from both the U.S. FDA and European Commission, with an IND/CTA filing expected in 2022.
Taysha Gene Therapies (Nasdaq: TSHA) reported significant advancements in its clinical pipeline during Q3 2021. The company anticipates clinical safety and functional data for TSHA-120 in GAN, TSHA-101 in GM2 gangliosidosis, and preliminary data for the first-ever dosed patient in the CLN7 program, all expected in December 2021. Notably, Taysha completed five GMP campaigns to support its clinical programs and received Orphan Drug Designation for multiple therapies. However, net losses increased to $51.2 million, or $1.35 per share, from $15 million, or $1.28 per share, a year earlier.
Taysha Gene Therapies (Nasdaq: TSHA) has announced its participation in three significant healthcare conferences: the Stifel 2021 Virtual Healthcare Conference on November 15, 2021, the Jefferies London Healthcare Conference on November 17, 2021, and the 4th Annual Evercore ISI HealthCONx Virtual Conference on November 30, 2021. The company focuses on developing AAV-based gene therapies for monogenic CNS diseases. Key participants include CEO RA Session II, Chief Medical Officer Dr. Suyash Prasad, and CFO Kamran Alam.
Taysha Gene Therapies (NASDAQ: TSHA) announced it will report third-quarter financial results on November 10, 2021, at 8:00 AM Eastern Time. The company is focused on developing AAV-based gene therapies for central nervous system diseases, aiming to provide curative treatments for both rare and larger patient populations. The conference will include a corporate update and access to a webcast will be available for 30 days post-event.
Taysha Gene Therapies (NASDAQ: TSHA) has announced promising preclinical data on an AAV-mediated UBE3A gene replacement therapy for Angelman syndrome. This novel approach, developed by Drs. Ben Philpot and Steven Gray, successfully packages both short and long isoforms of the UBE3A gene, showing improved motor learning, behavior, and seizure outcomes in mouse models. The therapy is seen as a potential safe treatment for Angelman syndrome, impacting approximately 55,000 patients in the U.S. and Europe. Further insights and data will be shared during the upcoming investor day on October 26, 2021.
Taysha Gene Therapies, Inc. (NASDAQ: TSHA) will participate in a fireside chat at the Jefferies Gene Therapy & Editing Summit on October 28, 2021, at 11:00 am ET. This pivotal-stage company focuses on developing AAV-based gene therapies for monogenic diseases affecting the central nervous system. Key participants include RA Session II, President and CEO; Dr. Suyash Prasad, Chief Medical Officer; Kamran Alam, CFO; and Dr. Kimberly Lee, SVP of Corporate Communications. Taysha aims to rapidly translate innovative therapies from research to clinical application.
Taysha Gene Therapies has launched a partnership with GeneDx to provide free genetic testing for Giant Axonal Neuropathy (GAN) to individuals at risk. This initiative aims to enhance disease awareness and improve diagnostic accessibility, addressing the estimated 2,400 patients with GAN in the US and Europe. The company's gene therapy, TSHA-120, has shown promising results in halting disease progression in clinical trials. Data from the high-dose cohort is expected in late 2021.
Taysha Gene Therapies will host a virtual webinar on October 26, 2021, from 10:00 a.m. to 1:00 p.m. ET, focusing on TSHA-106 for treating Angelman syndrome. The event will feature expert presentations, including Dr. Ben Philpot on gene replacement strategies, Dr. Kimberly Goodspeed on the syndrome overview, Dr. Allyson Berent discussing disease burden, Dr. Ryan Butler on UBE3A-ATS approaches, and Dr. Suyash Prasad reviewing clinical development strategies. Registration and live viewing are available on Taysha's website.
Taysha Gene Therapies (NASDAQ: TSHA) has announced advancements in its CLN7 gene therapy program. Currently in Phase 1 clinical trials, preliminary data is expected by year-end 2021. The company has partnered with UT Southwestern to develop an improved next-generation construct aimed at enhancing potency and safety. Data from preclinical studies show significant improvements in motor function and life expectancy in affected mice. Taysha plans to initiate a pivotal trial in 2022, with an estimated 4,000 CLN7 patients globally and no current approved therapies.
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