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

Taysha Gene Therapies (Nasdaq: TSHA) has received orphan drug designation from the European Commission for its leading gene therapy candidate, TSHA-105, aimed at treating SLC13A5-related epilepsy. This rare genetic condition lacks approved treatments, affecting approximately 1,900 patients across the U.S. and Europe. The designation highlights the urgent need for effective therapies and provides Taysha with regulatory advantages, including market exclusivity and reduced fees. TSHA-105 also holds orphan designation from the FDA, emphasizing its potential to address this debilitating condition.

Taysha Gene Therapies (Nasdaq: TSHA) is hosting a virtual key opinion leader webinar on TSHA-118, aimed at treating CLN1 disease, on August 30, 2021, from 10:00 a.m. to 12:30 p.m. ET. The event will feature Dr. Angela Schulz, who will present an overview of CLN1 disease, along with patient perspectives and preclinical data for TSHA-118. Notable speakers include Sharon King and Steven Gray, with a Q&A session to follow. Registration is available online, and an archived version will be accessible for 60 days post-event.

Taysha Gene Therapies, Inc. (Nasdaq: TSHA) reported its Q2 2021 financial results, showcasing significant advancements in developing gene therapies for CNS diseases. A non-dilutive financing of up to $100 million was secured, enhancing cash reserves to $197.4 million. Positive feedback from regulators for multiple programs allows for anticipated IND filings later this year. R&D expenses increased to $30.6 million, and net loss was $40.9 million. Upcoming milestones include clinical trial data releases and regulatory updates, reflecting a robust pipeline.

Taysha Gene Therapies (Nasdaq: TSHA) announced a loan agreement with Silicon Valley Bank providing up to $100 million in financing. Of this, $40 million is available at closing, with Taysha having drawn $30 million so far. This non-dilutive financing will enhance Taysha's financial flexibility to pursue various milestones, including a potential regulatory approval for TSHA-120 in giant axonal neuropathy. The interest rate for the loan will be the greater of 7.0% or the WSJ Prime Rate plus 3.75%.

Taysha Gene Therapies (Nasdaq: TSHA) will report its second-quarter financial results for the period ending June 30, 2021, on August 16, 2021, at 8:00 AM ET. This pivotal-stage gene therapy company focuses on AAV-based therapies targeting monogenic central nervous system diseases. The company aims to provide updates on their progress and future outlook during the conference call.

Taysha Gene Therapies (Nasdaq: TSHA) announced its participation in two upcoming virtual conferences. The BTIG Virtual Biotechnology Conference will take place on August 9, 2021, at 11:30 am ET, featuring a fireside chat with key executives including the President and CEO, RA Session II, and others. Additionally, the Wedbush Pacgrow Healthcare Virtual Conference is scheduled for August 11, 2021, at 8:35 am ET, where the same executives will participate in a panel discussion. Webcasts for both events will be available on Taysha's corporate website.

Taysha Gene Therapies (Nasdaq: TSHA) announced a virtual manufacturing day for analysts and investors, scheduled for July 27, 2021, from 10:00 a.m. to 1:00 p.m. ET. The event will cover the company’s manufacturing capabilities, regulatory environment, and gene therapy immunology, followed by Q&A sessions. Presentations will feature senior leaders, including Frederick Porter, Greg Gara, and Suyash Prasad. Registration is available via LifeSci Events, and a live video webcast will also be accessible. Taysha is committed to developing AAV-based gene therapies for monogenic CNS diseases.

Taysha Gene Therapies (Nasdaq: TSHA) announced its participation in the William Blair Biotech Focus Conference 2021. The event is scheduled for July 15, 2021, at 11:00 am ET, featuring a fireside chat format. Key executives, including RA Session II (President and CEO), Dr. Suyash Prasad (Chief Medical Officer), and Kamran Alam (Chief Financial Officer), will participate. A live webcast will be accessible via Taysha's website, with an archived version available for 60 days. Taysha focuses on developing gene therapies for central nervous system diseases.

Taysha Gene Therapies (Nasdaq: TSHA) announced the publication of new analyses of natural history data for TSHA-120 in giant axonal neuropathy (GAN) in the journal Brain. The study assessed 45 patients aged 3-21 with genetically confirmed GAN to explore genotype-phenotype correlations and markers of disease severity. The findings indicate a clinical difference between early-onset and late-onset GAN patients, with early-onset showing more severe progression. Taysha aims to leverage these insights to support its ongoing clinical trials and regulatory discussions for TSHA-120, expected to report data later this year.