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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) has received orphan drug designation from the European Commission for its leading gene therapy candidate, TSHA-105, aimed at treating SLC13A5-related epilepsy. This rare genetic condition lacks approved treatments, affecting approximately 1,900 patients across the U.S. and Europe. The designation highlights the urgent need for effective therapies and provides Taysha with regulatory advantages, including market exclusivity and reduced fees. TSHA-105 also holds orphan designation from the FDA, emphasizing its potential to address this debilitating condition.
Taysha Gene Therapies (Nasdaq: TSHA) is hosting a virtual key opinion leader webinar on TSHA-118, aimed at treating CLN1 disease, on August 30, 2021, from 10:00 a.m. to 12:30 p.m. ET. The event will feature Dr. Angela Schulz, who will present an overview of CLN1 disease, along with patient perspectives and preclinical data for TSHA-118. Notable speakers include Sharon King and Steven Gray, with a Q&A session to follow. Registration is available online, and an archived version will be accessible for 60 days post-event.
Taysha Gene Therapies, Inc. (Nasdaq: TSHA) reported its Q2 2021 financial results, showcasing significant advancements in developing gene therapies for CNS diseases. A non-dilutive financing of up to $100 million was secured, enhancing cash reserves to $197.4 million. Positive feedback from regulators for multiple programs allows for anticipated IND filings later this year. R&D expenses increased to $30.6 million, and net loss was $40.9 million. Upcoming milestones include clinical trial data releases and regulatory updates, reflecting a robust pipeline.
Taysha Gene Therapies (Nasdaq: TSHA) announced a loan agreement with Silicon Valley Bank providing up to $100 million in financing. Of this, $40 million is available at closing, with Taysha having drawn $30 million so far. This non-dilutive financing will enhance Taysha's financial flexibility to pursue various milestones, including a potential regulatory approval for TSHA-120 in giant axonal neuropathy. The interest rate for the loan will be the greater of 7.0% or the WSJ Prime Rate plus 3.75%.
Taysha Gene Therapies (Nasdaq: TSHA) will report its second-quarter financial results for the period ending June 30, 2021, on August 16, 2021, at 8:00 AM ET. This pivotal-stage gene therapy company focuses on AAV-based therapies targeting monogenic central nervous system diseases. The company aims to provide updates on their progress and future outlook during the conference call.
Taysha Gene Therapies (Nasdaq: TSHA) announced its participation in two upcoming virtual conferences. The BTIG Virtual Biotechnology Conference will take place on August 9, 2021, at 11:30 am ET, featuring a fireside chat with key executives including the President and CEO, RA Session II, and others. Additionally, the Wedbush Pacgrow Healthcare Virtual Conference is scheduled for August 11, 2021, at 8:35 am ET, where the same executives will participate in a panel discussion. Webcasts for both events will be available on Taysha's corporate website.
Taysha Gene Therapies (Nasdaq: TSHA) announced a virtual manufacturing day for analysts and investors, scheduled for July 27, 2021, from 10:00 a.m. to 1:00 p.m. ET. The event will cover the company’s manufacturing capabilities, regulatory environment, and gene therapy immunology, followed by Q&A sessions. Presentations will feature senior leaders, including Frederick Porter, Greg Gara, and Suyash Prasad. Registration is available via LifeSci Events, and a live video webcast will also be accessible. Taysha is committed to developing AAV-based gene therapies for monogenic CNS diseases.
Taysha Gene Therapies (Nasdaq: TSHA) announced its participation in the William Blair Biotech Focus Conference 2021. The event is scheduled for July 15, 2021, at 11:00 am ET, featuring a fireside chat format. Key executives, including RA Session II (President and CEO), Dr. Suyash Prasad (Chief Medical Officer), and Kamran Alam (Chief Financial Officer), will participate. A live webcast will be accessible via Taysha's website, with an archived version available for 60 days. Taysha focuses on developing gene therapies for central nervous system diseases.
Taysha Gene Therapies (Nasdaq: TSHA) announced the publication of new analyses of natural history data for TSHA-120 in giant axonal neuropathy (GAN) in the journal Brain. The study assessed 45 patients aged 3-21 with genetically confirmed GAN to explore genotype-phenotype correlations and markers of disease severity. The findings indicate a clinical difference between early-onset and late-onset GAN patients, with early-onset showing more severe progression. Taysha aims to leverage these insights to support its ongoing clinical trials and regulatory discussions for TSHA-120, expected to report data later this year.
Taysha Gene Therapies (Nasdaq: TSHA) announced its first virtual R&D day for analysts and investors on June 28-29, 2021. The event will showcase the company's progress in AAV-based gene therapies targeting monogenic CNS diseases. Key discussions will include programs like TSHA-120 for giant axonal neuropathy and TSHA-101 for GM2 gangliosidosis. Senior leaders and experts will present, with webcasts available live and archived for 60 days. Registration is open via LifeSci Events. Taysha aims to accelerate the development of curative treatments for rare CNS disorders.
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