• Taysha Gene Therapies (NasdaqGS:TSHA) has dosed the first patient in its pivotal REVEAL trial of TSHA-102 for Rett syndrome.
• The REVEAL study design has received FDA approval, supporting the structure of this key registrational trial.
• The company expects updated safety and efficacy data from the trial in the first half of 2026.

Taysha Gene Therapies enters this next clinical phase with its share price at $4.66 and a 3 year return of 278.9%. The stock has also recorded a 1 year return of 204.6%, although the move year to date has been an 11.2% decline, highlighting how sensitive smaller biotech names can be to news flow and sentiment.

For investors tracking gene therapy names, the start of a pivotal trial for TSHA-102 indicates that Taysha’s lead program is moving into a stage that could later support regulatory submissions if results are supportive. The upcoming data readout in the first half of 2026, together with FDA backing of the trial design, is likely to be a key focus point for how the market assesses both the therapy’s potential and the company’s development path.

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Quick Assessment

• ✅ Price vs Analyst Target: At US$4.66, the share price sits well below the US$11.00 analyst target range midpoint.
• ✅ Simply Wall St Valuation: Simply Wall St currently views the shares as trading about 95.2% below its estimated fair value.
• ❌ Recent Momentum: The 30 day return of about 11% decline signals weak short term sentiment.

Check out Simply Wall St's in depth valuation analysis for Taysha Gene Therapies.

Key Considerations

• 📊 First patient dosing in the pivotal REVEAL trial moves TSHA-102 into a stage where clinical outcomes for Rett syndrome become central to the story.
• 📊 Keep an eye on the 2026 safety and efficacy readout, cash needs, and any updates to the FDA supported trial design.
• ⚠️ The company is loss making, has seen substantial shareholder dilution over the past year, and carries four flagged risks in total.

Dig Deeper

For the full picture including more risks and rewards, check out the complete Taysha Gene Therapies analysis.

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.