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Taysha Gene Therapies, Inc. - TSHA STOCK NEWS

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.

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Taysha Gene Therapies, Inc. (Nasdaq: TSHA) announced the granting of 257,700 shares of common stock to Meredith Schultz, M.D., M.S., as an inducement for her employment as the new Senior Vice President, Clinical Development and Medical Affairs. The stock option has an exercise price of $1.71 per share, with a 10-year term and will vest over four years. This announcement was made in accordance with Nasdaq Listing Rule 5635(c)(4).
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Trinity Capital Inc. (NASDAQ: TRIN) commits $40 million in term loans to Taysha Gene Therapies, Inc. (NASDAQ: TSHA) for the clinical development of its lead gene therapy program TSHA-102 in Rett syndrome. Taysha aims to bring novel disease-modifying treatments for CNS diseases with high unmet needs, leveraging AAV-based gene therapies and proven management expertise.
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Taysha Gene Therapies, a clinical-stage gene therapy company (Nasdaq: TSHA), has received authorization from Health Canada for a protocol amendment expanding eligibility to include patients aged 12 and older with stage four Rett syndrome in the REVEAL Phase 1/2 adult trial in Canada. The amendment broadens TSHA-102 treatment potential to both adolescent and adult patients with Rett syndrome. Dosing of the third patient in the adult trial and completion of cohort one are expected in the fourth quarter of 2023/first quarter of 2024.
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Taysha Gene Therapies, Inc. (Nasdaq: TSHA) reported positive data from the first two adult patients in the REVEAL Phase 1/2 trial for TSHA-102, a gene therapy for Rett syndrome. The results showed sustained improvement across key efficacy measures and new improvement in R-MBA, PGI-I, and hand function. The company also entered into a loan and security agreement with Trinity Capital, extending its cash runway into 2026.
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Taysha Gene Therapies, Inc. will report Q3 financial results and host a corporate update conference call on November 14, 2023, focusing on AAV-based gene therapies for CNS diseases.
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Taysha Gene Therapies presents new preclinical data on TSHA-102 in Rett syndrome at ESGCT Congress.
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Taysha Gene Therapies to present data on TSHA-102 program for Rett Syndrome at ESGCT Annual Congress
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Taysha Gene Therapies announces dosing of second Rett syndrome patient with TSHA-102 in adult trial, plans to dose first pediatric patient in 2024
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Taysha discontinues development of TSHA-120 in GAN due to study design challenges, pursues strategic options. Cash runway extended to Q4 2025 for TSHA-102 in Rett syndrome. Astellas declines exclusive license to TSHA-120. FDA recommends randomized trial for TSHA-120 efficacy.
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Taysha Gene Therapies (TSHA) receives Fast Track Designation (FTD) from the FDA for TSHA-102 gene therapy in clinical evaluation for Rett syndrome, highlighting the potential as a meaningful treatment option for patients. Initial data from the first adult patient is encouraging. The company plans to expand the evaluation to pediatric patients.
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FAQ

What is the current stock price of Taysha Gene Therapies (TSHA)?

The current stock price of Taysha Gene Therapies (TSHA) is $1.85 as of December 20, 2024.

What is the market cap of Taysha Gene Therapies (TSHA)?

The market cap of Taysha Gene Therapies (TSHA) is approximately 379.1M.

What does Taysha Gene Therapies, Inc. specialize in?

Taysha Gene Therapies specializes in developing and commercializing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS).

What is TSHA-102?

TSHA-102 is Taysha's lead clinical program, an AAV9 gene transfer therapy designed to treat Rett syndrome by delivering a functional form of the MECP2 gene.

What recent achievements has Taysha Gene Therapies accomplished?

Taysha recently received RMAT designation for TSHA-102 and IDMC approval for dose escalation in clinical trials. They also extended their cash runway into 2026 with a new loan agreement.

What are the main focuses of Taysha's clinical trials?

Taysha's clinical trials focus on evaluating the safety and efficacy of TSHA-102 in treating Rett syndrome across different age groups, including both adolescent/adult and pediatric cohorts.

What designations has TSHA-102 received from regulatory bodies?

TSHA-102 has received Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the FDA, and Orphan Drug designation from the European Commission.

What strategic partnerships does Taysha Gene Therapies have?

Taysha has a strategic partnership with the University of Texas Southwestern Medical Center to develop and commercialize transformative gene therapy treatments.

How is Taysha addressing financial stability?

Taysha entered a new loan agreement, facilitating IP transfers for deprioritized programs and extending their cash runway into 2026.

What is the significance of the miRARE technology used in TSHA-102?

The miRARE technology in TSHA-102 helps mediate MECP2 levels in the CNS on a cell-by-cell basis, reducing the risk of overexpression.

Where can I find more information about Taysha Gene Therapies?

More information is available on Taysha's official website at www.tayshagtx.com.

Who can I contact for investor relations at Taysha Gene Therapies?

For investor relations inquiries, you can contact Hayleigh Collins, Director, Head of Corporate Communications and Investor Relations, at hcollins@tayshagtx.com.

Taysha Gene Therapies, Inc.

Nasdaq:TSHA

TSHA Rankings

TSHA Stock Data

379.15M
168.95M
17.54%
77.2%
7.69%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
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