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 Timeline and 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:
- October 27, 2025
- Indication:
- Food Allergy
Announcement
RAPT Therapeutics, Inc announced that it has initiated the randomized, double-blind, placebo-controlled prestIgE Phase 2b clinical trial of ozureprubart (formerly RPT904) in IgE-mediated food allergy.
AI Summary
RAPT Therapeutics, Inc. has launched the prestIgE Phase 2b trial of ozureprubart (formerly RPT904), a half-life extended anti-IgE antibody, in patients with IgE-mediated food allergies. This randomized, double-blind, placebo-controlled study will enroll about 100 participants across 30 sites in the U.S., Canada and Australia.
Participants with peanut, milk, egg, walnut or cashew allergies will receive ozureprubart subcutaneously every eight or 12 weeks (with a second loading dose) or placebo, in a 2:2:1 ratio. The primary endpoint is the percentage of subjects who reach a prespecified tolerance threshold during a double-blind, placebo-controlled oral food challenge at Week 24.
Brian Wong, M.D., Ph.D., RAPT’s CEO, said the trial builds on strong early data and aims to offer patients a more durable, less frequent dosing option. Hugh Sampson, M.D., highlighted ozureprubart’s potential as a transformative bio-better to omalizumab.
Read Announcement- Drug:
- RPT904
- Announced Date:
- October 20, 2025
- Indication:
- Food Allergy
Announcement
RAPT Therapeutics, Inc. announced positive topline data from Jeyou's Phase 2 trial of RPT904 (JYB1904) as monotherapy in chronic spontaneous urticaria (CSU).
AI Summary
RAPT Therapeutics announced positive topline data from Shanghai Jeyou’s Phase 2 trial of RPT904 (JYB1904) in adults with chronic spontaneous urticaria (CSU). In this randomized, double-blind study, 137 patients received 300 mg of RPT904 either every eight weeks (Q8W) or as a single dose every twelve weeks (Q12W), while a comparator arm received 300 mg of omalizumab every four weeks (Q4W). Both RPT904 schedules produced numerically greater reductions in the seven-day UAS7 symptom score at Weeks 8, 12 and 16, and higher rates of complete symptom relief (UAS7 = 0), compared to omalizumab Q4W. Efficacy was sustained through Week 16 after one RPT904 dose.
RPT904 was well tolerated, with no serious adverse events related to the study drug. Based on these results, Jeyou plans to advance RPT904 into Phase 3 development in China, and RAPT will discuss its global Phase 3 path with the FDA. RAPT will host a conference call at 8:30 am ET today to review these data.
Read Announcement- Drug:
- RPT904
- Announced Date:
- October 19, 2025
- Indication:
- Food Allergy
Announcement
RAPT Therapeutics, Inc. announced that the Company plans to report topline data from the Phase 2 clinical trial of RPT904 (JYB1904) in patients with Chronic Spontaneous Urticaria (CSU) conducted by its partner, Shanghai Jeyou Pharmaceutical Co., Ltd.
AI Summary
RAPT Therapeutics, Inc. plans to share topline results from its partner Shanghai Jeyou Pharmaceutical’s Phase 2 clinical trial of RPT904 (JYB1904) in patients with Chronic Spontaneous Urticaria (CSU). The company will release data in a premarket press release and webcast on Monday, October 20, 2025. This study explores the safety and effectiveness of RPT904, a novel immunology-based treatment, and represents a key milestone in RAPT’s efforts to develop therapies for inflammatory and immunological diseases.
A live webcast and slide presentation will begin at 8:30 a.m. ET on October 20. Investors and analysts can pre-register online to receive phone numbers and passcodes for the conference call, which will include a live Q&A session. The webcast and an audio archive will be accessible at RAPT’s investor website: https://investors.rapt.com/events-and-presentations. This update follows RAPT’s focus on translating immunology research into new medicines for patients.
Read Announcement- 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 October 27, 2025, involving RPT904. The update was categorized as "Trial Initiation," with the company reporting: " RAPT Therapeutics, Inc announced that it has initiated the randomized, double-blind, placebo-controlled prestIgE Phase 2b clinical trial of ozureprubart (formerly RPT904) in IgE-mediated food allergy."
Currently, Rapt Therapeutics has one therapy (RPT904) targeting the following condition: Food Allergy.
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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
FDA progress for NASDAQ:RAPT last updated on 10/27/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
