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 (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.
Taysha Gene Therapies, Inc. (Nasdaq: TSHA) has announced multi-year collaborations with Cleveland Clinic and UT Southwestern to develop next-generation mini-gene payloads for AAV gene therapies targeting genetic epilepsies and other CNS disorders. Taysha has secured exclusive options on new payloads and intellectual property from these partnerships. Researchers will create mini-gene payloads addressing limitations in AAV gene therapy, with the aim of expanding treatable genetic CNS diseases. These collaborations leverage the capabilities of leading institutions to address vector capacity challenges.
Taysha Gene Therapies (Nasdaq: TSHA) has outlined its strategic priorities and business outlook for 2021. The company has transitioned to a clinical-stage entity and expanded its leadership team. Key milestones include reporting clinical data for GM2 gangliosidosis, initiating multiple clinical trials, and submitting several IND/CTA applications within the year. Taysha plans to advance drug candidates TSHA-101, TSHA-118, TSHA-102, and TSHA-104, and develop its internal cGMP facility while increasing its workforce significantly. The company aims to leverage its innovative platform for sustained value creation in gene therapy.
Taysha Gene Therapies (Nasdaq: TSHA) has expanded its leadership team with the appointments of Timothy J. Douros as Chief Legal Officer and Tracy M. Porter as Chief People Officer. Douros, with over 25 years in biotech law, comes from Bluebird Bio, bringing vital legal expertise in gene therapy development. Porter, with nearly 30 years in HR, previously led HR at Audentes Therapeutics and will enhance Taysha's talent acquisition and organizational growth. The company remains focused on developing innovative AAV-based gene therapies for monogenic CNS diseases.
Taysha Gene Therapies (Nasdaq: TSHA) announced that the FDA granted rare pediatric disease and orphan drug designations for TSHA-105, a gene therapy targeting SLC13A5-related epilepsy. This designation aims to expedite the development of therapies for serious conditions affecting children. SLC13A5 deficiency leads to severe epilepsy in infants, and the FDA's recognition highlights TSHA-105's potential as a therapeutic option. These designations bring benefits such as tax credits and market exclusivity, enhancing TSHA's prospects in drug development.
Taysha Gene Therapies (Nasdaq: TSHA) and UT Southwestern Medical Center have launched an innovation fund aimed at developing gene therapies for monogenic diseases affecting the central nervous system. This partnership will enhance UTSW's research capabilities and allow Taysha to have exclusive options on new programs and intellectual property. The collaboration has already produced 18 novel product candidates, including TSHA-101 and TSHA-118, which are now in clinical trials. The focus remains on accelerating the discovery of novel therapies to address unmet medical needs.
Taysha Gene Therapies (NASDAQ: TSHA) has announced a multi-year collaboration with AllStripes to advance TSHA-104, an AAV9-based gene therapy for SURF1-associated Leigh syndrome. The partnership will utilize AllStripes’ clinical database to enhance understanding of the disease's natural history and progression, targeting an Investigational New Drug application for 2021. TSHA-104 aims to address a critical unmet medical need, as there are currently no approved treatments for this severe neurological disorder, which typically presents in infancy and can be fatal within a few years.
Taysha Gene Therapies (Nasdaq: TSHA) has announced key leadership changes with the appointments of Greg Gara as Senior Vice President of Manufacturing and Kimberly Lee, D.O., as Senior Vice President of Corporate Communications and Investor Relations. Gara brings over 25 years of experience in biotechnology manufacturing, previously serving at Sarepta and AveXis. Dr. Lee offers over 20 years in corporate finance and communications, previously at Lexicon Pharmaceuticals. These appointments aim to enhance Taysha's mission to develop transformative gene therapies for central nervous system diseases.
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