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Rapt Therapeutics (RAPT) FDA Approvals

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Rapt Therapeutics' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Rapt Therapeutics (RAPT). Over the past two years, Rapt Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as RPT904. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

RPT904 FDA Regulatory Events

RPT904 is a drug developed by Rapt Therapeutics for the following indication: Food Allergy. 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.

Rapt Therapeutics FDA Events - Frequently Asked Questions

As of now, Rapt Therapeutics (RAPT) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Rapt Therapeutics (RAPT) has reported FDA regulatory activity for RPT904.

The most recent FDA-related event for Rapt Therapeutics occurred on September 29, 2025, involving RPT904. The update was categorized as "FDA Clearance," with the company reporting: "RAPT Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has cleared RAPT's Investigational New Drug (IND) Application to proceed to a Phase 2b clinical trial of RPT904 for the treatment of patients with food allergy."

Currently, Rapt Therapeutics has one therapy (RPT904) targeting the following condition: Food Allergy.

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:RAPT) was last updated on 10/1/2025 by MarketBeat.com Staff
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