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Tenaya Therapeutics (TNYA) FDA Events

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FDA Events for Tenaya Therapeutics (TNYA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Tenaya Therapeutics (TNYA). Over the past two years, Tenaya Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as TN-201 and TN-401. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Tenaya Therapeutics' Drugs in FDA Review

TN-201 - FDA Regulatory Timeline and Events

TN-201 is a drug developed by Tenaya Therapeutics for the following indication: Fully functional MYBPC3 gene. 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.

TN-401 - FDA Regulatory Timeline and Events

TN-401 is a drug developed by Tenaya Therapeutics for the following indication: For the treatment of arrhythmogenic right ventricular cardiomyopathy (ARVC) caused by Plakophilin-2 (PKP2) gene mutations. 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.

Tenaya Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Tenaya Therapeutics (TNYA) has reported FDA regulatory activity for the following drugs: TN-201 and TN-401.

The most recent FDA-related event for Tenaya Therapeutics occurred on April 24, 2025, involving TN-401. The update was categorized as "Interim Data," with the company reporting: "Tenaya Therapeutics, Inc. announced interim data from its ongoing RIDGE (NCT06311708) natural history and seroprevalence study of adults with arrhythmogenic right ventricular cardiomyopathy (ARVC) caused by mutations in the Plakophilin 2 (PKP2) gene will be presented at the Heart Rhythm Society's annual Heart Rhythm meeting taking place in San Diego, CA from April 24-27, 2025."

Current therapies from Tenaya Therapeutics in review with the FDA target conditions such as:

  • Fully functional MYBPC3 gene - TN-201
  • For the treatment of arrhythmogenic right ventricular cardiomyopathy (ARVC) caused by Plakophilin-2 (PKP2) gene mutations. - TN-401

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:TNYA) was last updated on 7/10/2025 by MarketBeat.com Staff
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