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Tempest Therapeutics (TPST) FDA Events

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FDA Events for Tempest Therapeutics (TPST)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Tempest Therapeutics (TPST). Over the past two years, Tempest Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as TPST-1120 and TPST-1495. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Tempest Therapeutics' Drugs in FDA Review

TPST-1120 - FDA Regulatory Timeline and Events

TPST-1120 is a drug developed by Tempest Therapeutics for the following indication: First-Line Regimen for Hepatocellular Carcinoma. 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.

TPST-1495 - FDA Regulatory Timeline and Events

TPST-1495 is a drug developed by Tempest Therapeutics for the following indication: Designed to block the receptors EP2 and EP4 in the prostaglandin pathway. 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.

Tempest 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, Tempest Therapeutics (TPST) has reported FDA regulatory activity for the following drugs: TPST-1120 and TPST-1495.

The most recent FDA-related event for Tempest Therapeutics occurred on June 30, 2025, involving TPST-1120. The update was categorized as "Received Approval," with the company reporting: "Tempest Therapeutics, Inc. announced that the company received approval from the National Medical Products Administration (NMPA) in China to proceed with a pivotal trial to evaluate amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab, the current standard of care, versus the standard of care alone in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC)."

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

  • First-Line Regimen for Hepatocellular Carcinoma - TPST-1120
  • Designed to block the receptors EP2 and EP4 in the prostaglandin pathway - TPST-1495

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