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.
- Drug:
- RPT904
- Announced Date:
- September 29, 2025
- Indication:
- Food Allergy
Announcement
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.
AI Summary
RAPT Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to begin a Phase 2b clinical trial of RPT904 for treating food allergies. RPT904 is a novel, half-life–extended anti-IgE monoclonal antibody designed to inhibit free and cell-bound human immunoglobulin E, a key driver of allergic reactions.
The Phase 2b “prestIgE” trial will be a randomized, double-blind, placebo-controlled study comparing two dosing schedules of RPT904—every eight weeks (Q8W) or every 12 weeks (Q12W), each with a loading dose at Week 2—against placebo in a 2:2:1 ratio. Part 1 will enroll about 100 participants with IgE-mediated allergies to peanut, milk, egg, walnut or cashew and run for 24 weeks, measuring response by oral food challenge. In Part 2, responders continue treatment through Week 48, after which all participants undergo another challenge and a 16-week safety follow-up.
RAPT aims to start this trial by year-end, moving closer to a best-in-class option for the large, underserved food allergy community.
Read Announcement
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
FDA Event Stage Terminology & Abbreviation Guide
- 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
