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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.
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Taysha Gene Therapies (Nasdaq: TSHA) has initiated screening for its Phase 1/2 REVEAL trial targeting Rett syndrome, with the first adult patient anticipated to be dosed in H1 2023. The company plans to submit a Clinical Trial Application to the UK MHRA and an IND to the U.S. FDA for TSHA-102 in pediatric patients in mid-2023 and H2 2023, respectively. Taysha's research and development expenses decreased significantly to $13.9 million in Q4 2022 from $37.9 million a year prior. Despite a net loss of $55.7 million for Q4 2022, the company holds $87.9 million in cash, expected to cover expenses into Q1 2024.
Taysha Gene Therapies (Nasdaq: TSHA) will disclose its financial results for Q4 and full-year 2022 on March 28, 2023, at 4:30 PM ET.
The conference call will provide updates on the company's progress in developing AAV-based gene therapies for rare CNS diseases. Participants can join via toll-free and international numbers. Taysha aims to eradicate monogenic CNS diseases by leveraging expertise and a robust gene therapy program.
Taysha Gene Therapies (Nasdaq: TSHA) provided an update on its TSHA-120 program for giant axonal neuropathy (GAN) following a Type B end-of-Phase 2 meeting with the FDA. The FDA acknowledged MFM32 as an acceptable endpoint and recommended dosing additional patients to support a Biologics License Application (BLA) submission. The company also announced the anticipated dosing of the first adult patient with Rett syndrome and plans to submit a Clinical Trial Application (CTA) in mid-2023. New management has implemented operational changes to enhance execution and milestones in 2023 are expected to drive key clinical developments.
Taysha Gene Therapies (Nasdaq: TSHA) has announced significant executive leadership changes as of December 16, 2022. Sean P. Nolan, formerly Chair of the Board, is now the Chief Executive Officer, succeeding RA Session II, who remains on the Board. Dr. Sukumar Nagendran has been appointed President and Head of R&D. Both leaders aim to advance clinical programs in Giant Axonal Neuropathy (GAN) and Rett syndrome and strengthen Taysha's partnership with Astellas. The company plans to host an investor call in January to discuss feedback from the FDA regarding GAN.