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 clinical-stage biotechnology company developing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system. Its news flow is heavily centered on TSHA-102, a self-complementary, intrathecally delivered AAV9 investigational gene transfer therapy in clinical evaluation for Rett syndrome.
On this TSHA news page, readers can follow company announcements about clinical progress in the REVEAL Phase 1/2 and pivotal trials, as well as the ASPIRE safety-focused study in younger females with Rett syndrome. Taysha regularly reports on enrollment status, dosing milestones, interim and longer-term safety and efficacy data, and supplemental analyses of functional outcomes and developmental milestones achieved post-TSHA-102.
Investors and followers of TSHA stock will also find regulatory updates, such as the FDA’s Breakthrough Therapy designation for TSHA-102 and alignment on pivotal trial protocols and statistical analysis plans intended to support a future Biologics License Application. Additional news items include financial results, capital-raising activities, amendments to at-the-market equity programs, and inducement grants of stock options under the company’s inducement plan.
Because Rett syndrome is a rare neurodevelopmental disorder with no approved disease-modifying therapies that address its genetic root cause, developments from Taysha’s TSHA-102 program are closely watched by patients, caregivers and market participants. This page aggregates these company-issued updates so that readers can monitor how clinical data, regulatory interactions and corporate actions may shape the trajectory of TSHA-102 and the broader Taysha pipeline over time.
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.
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.
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