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) reported progress on its TSHA-102 pivotal program for Rett syndrome, including dosing the first REVEAL pivotal trial patient in Q4 2025 and ongoing enrollment across multiple sites. The REVEAL pivotal trial is a single-arm, open-label study of a single intrathecal dose of 1x1015 vg in 15 females aged 6 to <22 years with a six-month interim analysis that may support a BLA.
The company said it reached written FDA alignment to include at least three months of safety data from the ASPIRE trial (N=3, aged 2 to <4 years) in a planned BLA to enable a broad label for patients ≥2 years. Dosing completion for REVEAL and ASPIRE is expected in Q2 2026, with a REVEAL Part A update expected in H1 2026.
Taysha Gene Therapies (Nasdaq: TSHA) announced that on December 3, 2025 its Compensation Committee granted inducement stock options to two new employees totaling 212,000 shares under the 2023 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
The options carry an exercise price of $4.49 (the closing price on the grant date), a 10-year term, and a four-year vesting schedule: 25% vest on the first anniversary of the vesting commencement date and the remaining 75% vest monthly over the next 36 months, subject to continued service.
Taysha Gene Therapies (NASDAQ: TSHA) reported Q3 2025 results and a corporate update on Nov 4, 2025. Key program milestone: TSHA-102 received FDA Breakthrough Therapy designation for Rett syndrome and the company finalized FDA alignment on the REVEAL pivotal protocol and SAP, including a 6-month interim analysis that may enable an accelerated BLA path. Taysha expects to dose the first pivotal patient in Q4 2025. Part A REVEAL data showed durable functional gains and safety: no treatment-related SAEs or DLTs in 12 patients (Oct 2025 cutoff). Financial highlights: cash $297.3M (runway into 2028), R&D $25.7M in Q3 2025, and net loss $32.7M for the quarter.
Taysha Gene Therapies (Nasdaq: TSHA) will report third quarter 2025 financial results for the period ended September 30, 2025, and will host a corporate update conference call and webcast on Tuesday, November 4, 2025 at 8:30 AM ET.
The event includes a toll-free dial-in, international number, and a webcast at https://ir.tayshagtx.com/news-events/events-presentations. Conference ID is TAYSHA. The call time in Central Time is 7:30 AM CT.
Taysha Gene Therapies (Nasdaq: TSHA) regained full global rights to its lead TSHA-102 Rett syndrome program after the 2022 Option Agreement with Astellas expired on Oct 16, 2025. TSHA-102 previously received FDA Breakthrough Therapy designation based on Part A REVEAL data (May 2025 cutoff) showing a generally well-tolerated safety profile and a 100% response rate on the pivotal trial primary endpoint.
First patient dosing in the REVEAL pivotal trial is scheduled this quarter; the single-arm trial will evaluate a 1x10^15 vg intrathecal dose in 15 females aged 6–<22, with a 6-month interim analysis that may support a BLA.
Taysha Gene Therapies (NASDAQ: TSHA) reported a supplemental analysis from Part A of the REVEAL Phase 1/2 trials for TSHA-102 in Rett syndrome on October 9, 2025. The analysis found a previously disclosed 100% response rate (N=10) for the primary endpoint of gain/regain of ≥1 natural‑history developmental milestone, with a total of 22 milestones achieved. Structured, validated scales showed 165 additional skills/improvements across communication, fine motor, gross motor and autonomic domains. Data reflect Part A high dose (1x10^15 vg; N=6) and low dose (5.7x10^14 vg; N=4) with a May 2025 cutoff. Poster and figures available on the company website.
Taysha Gene Therapies (Nasdaq: TSHA) announced that on October 1, 2025 its Compensation Committee granted inducement stock options to seven new employees totaling 1,289,600 shares under the 2023 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
The options carry an exercise price of $3.18 (equal to the closing price on the grant date), a 10-year term, and vest over four years (25% after one year, then monthly ratable vesting over 36 months), subject to continued service.
Taysha Gene Therapies (NASDAQ:TSHA) has received FDA Breakthrough Therapy designation for TSHA-102, its gene therapy treatment for Rett syndrome. The designation was granted based on clinical evidence from 12 patients in Part A of the REVEAL Phase 1/2 trials, showing a 100% response rate in developmental milestone achievement.
The company has also finalized FDA alignment on the REVEAL pivotal trial protocol and statistical analysis plan. Key elements include a 6-month interim analysis that could expedite BLA submission. The pivotal trial will evaluate 15 female patients aged 6-22 years, with a minimum success threshold of 33% response rate. Patient enrollment is scheduled to begin in Q4 2025.
Taysha Gene Therapies (Nasdaq: TSHA), a clinical-stage biotech company developing AAV-based gene therapies for CNS diseases, has granted stock options to five new employees. The Compensation Committee approved options to purchase 225,000 shares at an exercise price of $2.84 per share under the company's 2023 Inducement Plan.
The options have a 10-year term with a four-year vesting schedule: 25% vests after one year, followed by monthly vesting over 36 months. These grants were made in accordance with Nasdaq Listing Rule 5635(c)(4) as employment inducements.
Taysha Gene Therapies (NASDAQ: TSHA) reported significant progress in Q2 2025, highlighted by the commencement of site activation for their REVEAL pivotal trial for TSHA-102 in Rett syndrome treatment. The trial follows successful Phase 1/2 results showing a 100% response rate for the primary endpoint of developmental milestone gains.
The company significantly strengthened its financial position through a $230 million public offering, extending their cash runway into 2028. As of June 30, 2025, Taysha held $312.8 million in cash. Q2 2025 saw a net loss of $26.9 million ($0.09 per share), compared to $20.9 million in Q2 2024.
The REVEAL pivotal trial will enroll 15 females aged 6-22 years with Rett syndrome, with patient enrollment expected to begin in Q4 2025. Importantly, both high and low doses of TSHA-102 have shown favorable safety profiles with no treatment-related SAEs in 12 patients treated.
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