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Protara Therapeutics (TARA) FDA Events

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FDA Events for Protara Therapeutics (TARA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Protara Therapeutics (TARA). Over the past two years, Protara Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as TARA-002 and THRIVE-1. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Protara Therapeutics' Drugs in FDA Review

TARA-002 - FDA Regulatory Timeline and Events

TARA-002 is a drug developed by Protara Therapeutics for the following indication: Non-Muscle Invasive Bladder Cancer. 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.

THRIVE-1 - FDA Regulatory Timeline and Events

THRIVE-1 is a drug developed by Protara Therapeutics for the following indication: Evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS). 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.

Protara 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, Protara Therapeutics (TARA) has reported FDA regulatory activity for the following drugs: TARA-002 and THRIVE-1.

The most recent FDA-related event for Protara Therapeutics occurred on April 26, 2025, involving TARA-002. The update was categorized as "updated results," with the company reporting: "Protara Therapeutics, Inc. announced updated results from its ongoing Phase 2 open-label ADVANCED-2 trial assessing intravesical TARA-002, the Company's investigational cell-based therapy, in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients with carcinoma in situ, or CIS (± Ta/T1), who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve."

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

  • Non-Muscle Invasive Bladder Cancer - TARA-002
  • Evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS). - THRIVE-1

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