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Taysha Gene Therapies Gains FDA Breakthrough Designation

Story Highlights
  • Taysha Gene Therapies received FDA Breakthrough Therapy designation for TSHA-102 in Rett syndrome.
  • The company finalized FDA alignment on trial protocols, aiming for expedited BLA submission by Q4 2025.
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Taysha Gene Therapies Gains FDA Breakthrough Designation

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Taysha Gene Therapies ( (TSHA) ) has issued an announcement.

On October 2, 2025, Taysha Gene Therapies announced that the FDA granted Breakthrough Therapy designation to TSHA-102 for Rett syndrome, based on positive clinical evidence from their REVEAL Phase 1/2 trials. The company also finalized alignment with the FDA on the pivotal trial protocol and statistical analysis plan, aiming to expedite the Biologics License Application submission, with patient enrollment expected to begin in Q4 2025.

The most recent analyst rating on (TSHA) stock is a Buy with a $13.00 price target. To see the full list of analyst forecasts on Taysha Gene Therapies stock, see the TSHA Stock Forecast page.

Spark’s Take on TSHA Stock

According to Spark, TipRanks’ AI Analyst, TSHA is a Neutral.

Taysha Gene Therapies’ overall stock score reflects significant financial challenges, balanced by strong clinical progress and positive technical momentum. The company’s extended cash runway and regulatory achievements are promising, but ongoing losses and valuation concerns weigh on the score.

To see Spark’s full report on TSHA stock, click here.

More about Taysha Gene Therapies

Taysha Gene Therapies is a clinical-stage biotechnology company focused on developing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system. Its lead program, TSHA-102, targets Rett syndrome, a rare neurodevelopmental disorder with no approved disease-modifying therapies.

Average Trading Volume: 3,391,485

Technical Sentiment Signal: Buy

Current Market Cap: $867.5M

See more insights into TSHA stock on TipRanks’ Stock Analysis page.

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