Welcome to our dedicated page for Taysha Gene Therapies news (Ticker: TSHA), a resource for investors and traders seeking the latest updates and insights on Taysha Gene Therapies stock.
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 plans for clinical data updates in January 2022, focusing on TSHA-101 for GM2 gangliosidosis and TSHA-120 for giant axonal neuropathy (GAN). The virtual investor calls will cover preliminary clinical safety data and enzyme activity for TSHA-101, as well as safety and efficacy results for the highest dose of TSHA-120. Taysha aims to discuss the program's status, potential regulatory strategies, and commercialization efforts to improve the lives of patients with monogenic CNS diseases.
Taysha Gene Therapies (NASDAQ: TSHA) has been added to the ICE Biotechnology Index (NYSE: ICEBIO), effective December 20, 2021. This inclusion recognizes its value and platform in the biotechnology sector, focusing on gene therapies for central nervous system disorders. CEO RA Session II emphasized the importance of this validation as the company works towards clinical and regulatory milestones to enhance visibility within the investment community. The ICE Biotechnology Index tracks U.S.-listed biotech companies engaged in therapeutic research and development.
Taysha Gene Therapies (TSHA) reported preliminary clinical safety data for its first-generation CLN7 construct, demonstrating a favorable safety profile with no major adverse events observed. The Data Safety Monitoring Board supported dose escalation to the highest dose of 1.0x1015 viral genomes in humans. Upcoming results will be presented at the 18th Annual WORLDSymposium in February 2022. Additionally, Taysha has designed a next-generation construct aimed at enhancing potency and manufacturability while reducing immunogenicity risks.
Taysha Gene Therapies (NASDAQ: TSHA) has initiated the clinical development of TSHA-118 for treating CLN1 disease, following a recently approved Clinical Trial Application. The first clinical site is Queen’s University in Ontario, Canada, under Dr. Jagdeep Wahlia. Preclinical studies show that TSHA-118 can significantly improve survival and behavior in models of CLN1 disease, with preliminary clinical safety and enzyme activity data expected in H1 2022. This gene therapy holds promise as a disease-modifying treatment for CLN1 disease, which affects approximately 1 in 138,000 live births globally.
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.
FAQ
What is the current stock price of Taysha Gene Therapies (TSHA)?
What is the market cap of Taysha Gene Therapies (TSHA)?
What does Taysha Gene Therapies, Inc. specialize in?
What is TSHA-102?
What recent achievements has Taysha Gene Therapies accomplished?
What are the main focuses of Taysha's clinical trials?
What designations has TSHA-102 received from regulatory bodies?
What strategic partnerships does Taysha Gene Therapies have?
How is Taysha addressing financial stability?
What is the significance of the miRARE technology used in TSHA-102?
Where can I find more information about Taysha Gene Therapies?
Who can I contact for investor relations at Taysha Gene Therapies?
