Taysha Gets FDA Fast-Track for Rett Syndrome Treatment

By Dean Seal

Taysha Gene Therapies said regulators have granted fast-track designation for TSHA-102, a gene transfer therapy in clinical evaluation for the neurodevelopmental disorder Rett Syndrome.

The Dallas-based clinical-stage company said the special status from the U.S. Food and Drug Administration has been granted after encouraging initial data from the first adult patient in Canada dosed with TSHA-102. A second patient is set to be dosed in the current quarter.

The FDA's fast-track designation facilitates the development and expedites the review of drugs that treat serious or life-threatening conditions and fill unmet medical needs.

TSHA-102 also has received orphan-drug and rare-pediatric-disease designations from the FDA, as well as orphan-drug designation from the European Commission.

Shares climbed 8% to $2.40 in premarket trading.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

August 24, 2023 08:37 ET (12:37 GMT)

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