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Taysha Gene Therapies (TSHA) FDA Events

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FDA Events for Taysha Gene Therapies (TSHA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Taysha Gene Therapies (TSHA). Over the past two years, Taysha Gene Therapies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as TSHA-102. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

TSHA-102 - FDA Regulatory Timeline and Events

TSHA-102 is a drug developed by Taysha Gene Therapies for the following indication: Rett Syndrome. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Taysha Gene Therapies FDA Events - Frequently Asked Questions

As of now, Taysha Gene Therapies (TSHA) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Taysha Gene Therapies (TSHA) has reported FDA regulatory activity for TSHA-102.

The most recent FDA-related event for Taysha Gene Therapies occurred on June 3, 2025, involving TSHA-102. The update was categorized as "Oral presentation," with the company reporting: "Taysha Gene Therapies, Inc. announced details for three oral presentations reviewing recent updates supporting its TSHA-102 program in clinical evaluation for Rett syndrome, and a Taysha-hosted symposium on the Company's analysis of the natural history study data at the 2025 International Rett Syndrome Foundation (IRSF) Rett Syndrome Scientific Meeting, taking place in Boston from June 9-11, 2025."

Currently, Taysha Gene Therapies has one therapy (TSHA-102) targeting the following condition: Rett Syndrome.

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:TSHA) was last updated on 7/9/2025 by MarketBeat.com Staff
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