Taysha Gene Therapies, Inc. Stock Price, News & Analysis

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.

Taysha Gene Therapies Inc. (Nasdaq: TSHA) announced that its gene therapy TSHA-102 received both rare pediatric disease and orphan drug designations from the FDA for treating Rett syndrome. This genetic disorder affects over 25,000 individuals in the U.S. and EU and currently has no approved therapies targeting its underlying cause. The company plans to submit an Investigational New Drug (IND) application for TSHA-102 in 2021. The gene therapy aims to deliver a healthy version of the MECP2 gene, potentially offering a curative option for patients.

Taysha Gene Therapies Inc. (Nasdaq: TSHA) announced a partnership with Invitae to advance two genetic testing programs: Detect Lysosomal Storage Diseases and Behind the Seizure. These initiatives aim to enhance rapid diagnosis and patient identification for conditions like GM2 gangliosidosis and epilepsy. Eligible individuals will receive genetic testing and counseling at no cost, facilitating access to clinical trials and therapeutic interventions. The partnership is positioned to improve patient outcomes through earlier diagnoses and precision therapies, aligning with Taysha's mission to eradicate monogenic CNS diseases.

Taysha Gene Therapies (Nasdaq: TSHA) has announced the completion of its initial public offering, raising approximately $181 million. Underwriters exercised an option to purchase additional shares at $20.00 each, with the issuance closing on September 29, 2020. This offering is focused on funding AAV-based gene therapies for central nervous system diseases. Goldman Sachs, Morgan Stanley, and Jefferies were the main managers for the IPO, which was registered and declared effective by the SEC on September 23, 2020.