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 new preclinical data showcasing advancements in its gene therapy pipeline, emphasizing TSHA-113, which reduced tau expression in mouse models for tauopathies. Taysha plans to advance five programs into IND/CTA-enabling studies and file an IND for one candidate by year-end 2021. The company reported a significant commercial opportunity for therapies targeting various CNS diseases affecting large patient populations, including Alzheimer's, with a combined estimate of over 6 million Americans affected.
Taysha Gene Therapies (Nasdaq: TSHA) has acquired exclusive global rights to TSHA-120, a clinical-stage AAV9 gene therapy for giant axonal neuropathy (GAN). This therapy is currently in an NIH-led clinical trial, having received FDA designations as a rare pediatric disease and orphan drug. TSHA-120 shows promise in halting disease progression, with significant improvements in motor function observed in treated patients. The potential market opportunity is over $2 billion for approximately 2,400 patients in the U.S. and Europe. Taysha plans to engage with regulatory agencies to expedite the approval process.
Taysha Gene Therapies (Nasdaq: TSHA) announced its participation in two upcoming virtual conferences: the 20th Annual Needham Virtual Healthcare Conference on April 12, 2021, at 10:15 am ET and the Chardan 5th Annual Manufacturing Summit on April 26, 2021, at 1:00 pm ET. Both events will feature fireside chats led by key executives, including the President and CEO, RA Session II, along with others from the company.
Webcasts of these events can be accessed on the Taysha corporate website, with archived versions available for 60 days.
Taysha Gene Therapies (Nasdaq: TSHA) announced its upcoming participation in virtual fireside chats at the Oppenheimer 31st Annual Healthcare Conference on March 16, 2021, at 1:50 pm ET, and at Stifel’s 3rd Annual CNS Day on March 31, 2021, at 10:30 am ET. Both events will feature RA Session II, President, Founder and CEO. Audio webcasts will be available in the “Events & Media” section of Taysha's corporate website for 60 days after the events.
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.
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?
