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Taysha Gene Therapies, Inc. reports company developments as a clinical-stage biotechnology company advancing adeno-associated virus, or AAV, gene therapies for severe monogenic diseases of the central nervous system. Its lead program, TSHA-102, is an intrathecally delivered, self-complementary AAV9 investigational gene transfer therapy in clinical evaluation for Rett syndrome.
Recurring updates cover TSHA-102 clinical and preclinical data, FDA regulatory interactions and designations, manufacturing and comparability topics, financial results, corporate updates, and employee inducement equity grants under Nasdaq listing rules. Company communications also describe the program’s MECP2 construct design, miRARE technology, and clinical trial activity in Rett syndrome.
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.
Taysha Gene Therapies (Nasdaq: TSHA) announced that Queen’s University in Ontario has received Clinical Trial Application approval from Health Canada for the Phase 1/2 trial of TSHA-101, an AAV9-based gene therapy for infantile GM2 gangliosidosis. This trial marks TSHA-101 as the first bicistronic vector entering first-in-human studies. GM2 gangliosidosis is a fatal genetic disorder with no approved treatments, making this a pivotal moment for affected children.
Taysha Gene Therapies (Nasdaq: TSHA) has signed a lease for a 187,000-square-foot cGMP manufacturing facility in Durham, North Carolina. The company plans to invest $75 million and create 200 jobs over the next two and a half years. This facility will enhance their capabilities for producing gene therapies to meet clinical and commercial demand and is expected to be fully operational by 2023. Moreover, Taysha will receive up to $9.4 million in state and local incentives. This strategic move supports their growth plans and aims to accelerate the delivery of transformative treatments.
Taysha Gene Therapies (Nasdaq: TSHA) announced its inclusion in the Russell 2000® Index, effective December 21, 2020. This index measures the performance of small-cap U.S. equities and reflects approximately 10% of the total market capitalization of the Russell 3000® Index. With around $9 trillion in assets benchmarked against Russell indexes, this move is significant for Taysha as it enhances visibility among investors. The company focuses on developing AAV-based gene therapies for treating monogenic diseases of the central nervous system, aiming for rapid treatment translation from bench to bedside.
Taysha Gene Therapies (Nasdaq: TSHA) has received rare pediatric disease and orphan drug designations from the FDA for TSHA-103, a gene therapy targeting SLC6A1-related epilepsy. This recognition highlights the urgent need for therapies for this severe genetic disorder affecting children. The company emphasizes the significance of TSHA-103 in addressing unmet medical needs and plans to continue advancing its gene therapy pipeline. These designations could also lead to benefits such as priority review vouchers and market exclusivity for up to seven years after approval.
Taysha Gene Therapies (Nasdaq: TSHA) appointed Dr. Kathy Reape and Dr. Laura Sepp-Lorenzino to its board of directors. Both bring extensive experience in gene therapy, with Dr. Reape previously serving as Chief Medical Officer at Spark Therapeutics, where she contributed to the development of LUXTURNA®, the first FDA-approved in vivo gene therapy. Dr. Sepp-Lorenzino is currently Chief Scientific Officer at Intellia Therapeutics. Their expertise is expected to bolster Taysha's development of AAV-based gene therapies for central nervous system diseases, aiming to advance therapies for conditions with limited treatment options.
Taysha Gene Therapies, a gene therapy company focused on central nervous system diseases, reported financial results for Q3 2020. The company raised over $275 million through its Series B financing and IPO, enhancing its capabilities across 18 gene therapy programs. Significant advancements include securing FDA designations for TSHA-101 (for GM2 gangliosidosis) and TSHA-102 (for Rett syndrome), along with plans for clinical trials. Taysha also strengthened manufacturing partnerships and anticipates tripling its workforce by year-end 2020.
Taysha Gene Therapies Inc. (Nasdaq: TSHA) has received rare pediatric disease and orphan drug designations from the FDA for its gene therapy TSHA-104, which targets SURF1-associated Leigh syndrome. This designation is expected to facilitate the company’s collaboration with the FDA as it prepares to submit an Investigational New Drug (IND) application in 2021. Leigh syndrome is a severe neurological disorder usually diagnosed in infancy. Taysha aims to accelerate its gene therapy pipeline, having previously secured similar designations for other programs, enhancing its potential marketability.