Rapt Therapeutics (RAPT) FDA Approvals

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.

Top-line results - October 20,2025

Phase 2

• Drug: RPT904
• Announced Date: October 20, 2025
• Indication: Food Allergy

RAPT Therapeutics, Inc. announced positive topline data from Jeyou's Phase 2 trial of RPT904 (JYB1904) as monotherapy in chronic spontaneous urticaria (CSU).

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.

Top-line data - October 19,2025

Phase 2

• Drug: RPT904
• Announced Date: October 19, 2025
• Indication: Food Allergy

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.

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.

FDA Clearance - September 29,2025

NDA

• Drug: RPT904
• Announced Date: September 29, 2025
• Indication: Food Allergy

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.

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.

Rapt Therapeutics FDA Events - Frequently Asked Questions

Has Rapt Therapeutics received FDA approval?

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

What drugs has Rapt Therapeutics submitted to the FDA?

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

What is the most recent FDA event for Rapt Therapeutics?

The most recent FDA-related event for Rapt Therapeutics occurred on October 20, 2025, involving RPT904. The update was categorized as "Top-line results," with the company reporting: "RAPT Therapeutics, Inc. announced positive topline data from Jeyou's Phase 2 trial of RPT904 (JYB1904) as monotherapy in chronic spontaneous urticaria (CSU)."

What conditions do Rapt Therapeutics' current drugs treat?

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