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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) announced its participation in two upcoming virtual fireside chats at major biotechnology conferences on June 22, 2021. The first event is the LifeSci Genetics Medicine Conference at 10:00 am ET, while the second is the LSX Biotech Growth CEO Forum at 1:10 pm ET, focusing on optimizing value from discovery platforms. Key executives, including the CEO and CMO, will participate in these discussions. Webcasts will be available for 60 days on Taysha's corporate website.
Taysha Gene Therapies (Nasdaq: TSHA) announced its first annual stockholder meeting will take place on June 17, 2021, at 10 am ET via webcast. The meeting can be accessed through the company’s corporate website. Taysha focuses on developing AAV-based gene therapies for monogenic diseases affecting the central nervous system, with a commitment to translating therapies from bench to bedside. Their integrated approach aims to improve patient lives through innovative treatments.
Taysha Gene Therapies, Inc. (Nasdaq: TSHA) is participating in multiple upcoming healthcare conferences. The company will host a virtual fireside chat at:
- Jefferies Virtual Healthcare Conference on June 2, 2021, at 10:30 am ET
- Goldman Sachs 42nd Annual Global Healthcare Conference on June 10, 2021, at 5:30 pm ET
- JMP Securities Life Science Conference on June 16, 2021, at 12:30 pm ET
Featured participants include RA Session II, Dr. Suyash Prasad, and Kamran Alam. Webcasts will be available for 60 days on their corporate website.
Taysha Gene Therapies (Nasdaq: TSHA) has joined the newly formed Rare Disease Company Coalition, aimed at advocating for rare disease treatments. This coalition is composed of leading life sciences companies committed to overcoming the challenges in rare disease drug development. The coalition plans to engage with policymakers on critical healthcare policies, including prescription drug pricing. Taysha's CEO emphasized the importance of effective policies for innovative therapies, highlighting the company's commitment to improving treatment access for rare disease patients.
Taysha Gene Therapies (Nasdaq: TSHA) announced the appointment of Mary Newman as Chief Development Officer, enhancing its leadership team. Newman, with over 30 years in regulatory affairs and research within biotechnology, will manage program and portfolio operations, reporting to Chief Medical Officer Suyash Prasad. Her prior experience includes roles at Astellas Gene Therapies and BioMarin Pharmaceutical, where she contributed to significant drug approvals. CEO RA Session II emphasized Newman’s role in advancing Taysha’s ambitious pipeline for monogenic CNS disorders.
Taysha Gene Therapies (Nasdaq: TSHA) announced its participation in two virtual events: the 2021 RBC Capital Markets Global Healthcare Conference on May 19 at 3:05 PM ET and the Oppenheimer Rare & Orphan Disease Summit on May 21 at 4:35 PM ET. The discussions will involve key executives including RA Session II, Dr. Suyash Prasad, and Kamran Alam. Webcasts will be available in the Events & Media section of their corporate website for 60 days after the events.
Taysha Gene Therapies (Nasdaq: TSHA) reported Q1 2021 financial results, noting a net loss of $32 million, or $0.87 per share, compared to $5.4 million, or $0.50 per share in Q1 2020. The company acquired TSHA-120 for GAN, showing promising clinical data with 14 patients dosed. Preclinical results for TSHA-102 in Rett syndrome demonstrated a significant 56% survival extension in knockout mice. Taysha plans to advance five programs into Phase 1/2 trials by year-end and aims to submit an IND application for TSHA-102 by then. The company has $228.7 million in cash, expected to support operations into 2023.
Taysha Gene Therapies, Inc. (Nasdaq: TSHA) has published promising preclinical data for TSHA-102 in treating Rett syndrome, featured in the renowned journal Brain. TSHA-102 employs a novel self-regulatory mechanism that enables controlled expression of MECP2, which is critical for avoiding overexpression toxicity. In studies, TSHA-102 extended the survival of knockout mice by 56%, contrasting with unregulated treatments that showed unacceptable toxicity. The company plans to file an IND/CTA for TSHA-102 in the second half of the year and initiate a Phase 1/2 trial by year-end 2021, addressing a significant need for 25,000 patients.
Taysha Gene Therapies, Inc. (Nasdaq: TSHA) announced the presentation of promising preclinical data at the 24th Annual Meeting of the American Society of Gene & Cell Therapy. Key highlights include positive results for TSHA-104 in treating SURF1-associated Leigh syndrome and TSHA-105 for SLC13A5 deficiency. Both therapies showed significant efficacy in enhancing neurological functions in mouse models. Taysha plans to file an IND/CTA for TSHA-104 later this year and continue progressing TSHA-105 towards clinical trials.
Taysha Gene Therapies (Nasdaq: TSHA) has announced a conference call for a corporate update and to report its financial results for Q1 2021, scheduled for May 11, 2021, at 8:00 AM ET. The company focuses on AAV-based gene therapies for monogenic CNS diseases and is dedicated to translating scientific advancements into curative medicines. Taysha aims to leverage its partnership with UT Southwestern Gene Therapy Program to enhance its gene therapy pipeline, addressing both rare and large patient populations.
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