Jasper Therapeutics (JSPR) FDA Approvals

Jasper Therapeutics' Drug in the FDA Approval Process

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

Briquilimab FDA Regulatory Timeline and Events

Briquilimab is a drug developed by Jasper Therapeutics for the following indication: To address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). 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.

Clinical Data - January 8,2026

Phase 1b/2a

• Drug: Briquilimab
• Announced Date: January 8, 2026
• Indication: To address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU)

Jasper Therapeutics is reporting positive updated clinical data from Jasper's BEACON Phase 1b/2a study of subcutaneous briquilimab in adult participants with CSU, as well as from the open label extension study in CSU and CIndU.

Jasper Therapeutics reported positive updated data from its BEACON Phase 1b/2a study of subcutaneous briquilimab in adults with chronic spontaneous urticaria (CSU). In the added 240 mg/180 mg Q8W cohort, 83% of participants dosed with briquilimab (n=6) had a complete response by week 3, and 67% reported a complete response at 12 weeks. The mean UAS7 reduction at 12 weeks was 31 points for those patients.

In the open-label extension (180 mg Q8W), 58% of CSU patients (n=36) achieved a complete response at 12 weeks, and 75% achieved either complete response or well-controlled disease (UAS7 ≤6). In the CIndU group (n=17), 65% had a complete or partial response at 16 weeks. Across 63 patients with a median follow-up of about 205 days, KIT-related adverse events were infrequent, mostly low-grade, and generally resolved while on study.

Jasper said these BEACON and open-label data are now sufficient to select doses for a planned Phase 2b CSU study expected to begin in the second half of 2026.

Preliminary Data - December 2,2025

Phase 1b

• Drug: Briquilimab
• Announced Date: December 2, 2025
• Indication: To address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU)

Jasper Therapeutics, reported positive preliminary clinical data from Jasper's ETESIAN Phase 1b study of subcutaneous briquilimab in adult participants with allergic asthma.

Jasper Therapeutics reported positive preliminary results from the ETESIAN Phase 1b study of subcutaneous briquilimab in adults with allergic asthma. A single 180 mg dose reduced sputum eosinophils at both six and twelve weeks and produced significant drops in serum tryptase, consistent with mast cell depletion. Briquilimab also improved lung function measures in both the early and late asthmatic responses and increased resistance to methacholine challenge, suggesting reduced airway hyperresponsiveness.

The preliminary analysis included 14 participants (8 active, 6 placebo). Briquilimab improved late asthmatic response %Max FEV1 by about 10.4% at six weeks and 8.7% at twelve weeks, and cut 24-hour post-allergen sputum eosinophils from 10.3% at baseline to 2.32% at six weeks and 3.98% at twelve weeks.

The drug was well tolerated with no dose-limiting toxicities observed. Jasper said these data support further development of briquilimab for asthma.Read Announcement

Updated data - July 7,2025

Phase 1b/2a

• Drug: Briquilimab
• Announced Date: July 7, 2025
• Indication: To address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU)

Jasper Therapeutics is reporting updated data from Company's BEACON Phase 1b/2a study of subcutaneous briquilimab in adult participants with CSU and providing an update on the program. Briquilimab administration resulted in deep and rapid disease control in the 240mg and 360mg single-dose cohorts, with 8 of 9 (89%) of participants enrolled across both cohorts achieving a complete response, and with 7 of 9 (78%) achieving a clinical response by week 2.

Jasper Therapeutics has released updated data from its BEACON Phase 1b/2a study that evaluated subcutaneous briquilimab in adult patients with chronic spontaneous urticaria (CSU). In the study, participants receiving a single dose of either 240mg or 360mg of briquilimab showed rapid and deep disease control. Notably, 8 out of 9 patients (89%) in these single-dose cohorts achieved a complete response, and 7 out of 9 (78%) reached a clinical improvement by week 2. Additionally, patients who enrolled in the open-label extension study and received a dose of 180mg every 8 weeks reported a 73% complete response rate at 12 weeks. These promising results highlight the potential of briquilimab to treat the underlying causes of CSU effectively and support further clinical development to optimize dosing and outcomes for patients suffering from this condition.

Abstract Presentation - June 3,2025

• Drug: Briquilimab
• Announced Date: June 3, 2025
• Indication: To address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU)

Jasper Therapeutics, announced that four abstracts have been accepted for presentation at the EAACI Congress 2025, to be held June 13-16, 2025 in Glasgow, United Kingdom. Jasper will present initial clinical data from patients enrolled in the 180mg cohort of the SPOTLIGHT Phase 1b/2a study evaluating briquilimab in subcutaneous briquilimab in cold urticaria (ColdU) or symptomatic dermographism (SD) during an oral session on Saturday, June 14.

Jasper Therapeutics announced that four abstracts have been accepted for presentation at the EAACI Congress 2025, which will be held in Glasgow, United Kingdom, from June 13 to 16, 2025. The company will showcase initial clinical data from patients enrolled in the 180mg cohort of the SPOTLIGHT Phase 1b/2a study. This study is evaluating the use of briquilimab, a novel antibody therapy, for treating cold urticaria (ColdU) and symptomatic dermographism (SD). One of the presentations is scheduled during an oral session on Saturday, June 14, where Jasper will detail the therapeutic potential of briquilimab in rapidly controlling these conditions. These abstracts underline Jasper’s commitment to advancing treatment options for mast cell-driven diseases and highlight promising early-phase clinical outcomes that could lead to improved patient care in conditions like ColdU and SD.

Clinical Data - March 1,2025

Phase 1b/2a

• Drug: Briquilimab
• Announced Date: March 1, 2025
• Indication: To address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU)

Jasper Therapeutics, Inc. is presenting updated clinical data from the Phase 1b/2a BEACON study, as well as data from four preclinical studies evaluating briquilimab, at the AAAAI 2025 Annual Meeting, being held February 28 - March 3, 2025, in San Diego, CA.

Jasper Therapeutics, Inc. is set to present updated clinical information from its Phase 1b/2a BEACON study at the AAAAI 2025 Annual Meeting in San Diego, CA, scheduled for February 28 to March 3, 2025. The updated data includes one extra month of dosing and follow-up from 49 participants, showing that briquilimab is well tolerated with no new adverse events related to c-Kit blockade.

In addition to the BEACON study results, Jasper will present findings from four preclinical studies evaluating briquilimab. These studies further support the potential of briquilimab, a novel antibody therapy targeting c-Kit, in treating mast cell-driven diseases like chronic spontaneous urticaria, chronic inducible urticaria, and asthma. The data could influence the design of a planned Phase 2b operationally adaptive study set to begin later in 2025.

Poster Presentation - February 10,2025

• Drug: Briquilimab
• Announced Date: February 10, 2025
• Indication: To address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU)

Jasper Therapeutics, announced five poster presentations and an oral presentation of briquilimab data at the AAAAI 2025 Annual Meeting, being held February 28 - March 3, 2025, in San Diego, CA.

Jasper Therapeutics recently announced that it will present briquilimab data at the AAAAI 2025 Annual Meeting in San Diego, CA. The company will share its findings through five poster presentations and one oral presentation focused on this novel antibody therapy. These presentations will highlight briquilimab’s potential to treat mast cell-driven diseases such as chronic spontaneous urticaria and asthma by targeting the c‑Kit (CD117) receptor.

Notably, one poster session and the oral presentation will provide additional follow-up data from the ongoing Phase 1b/2a BEACON trial, which is exploring the drug’s effects in chronic spontaneous urticaria. The AAAAI event is scheduled from February 28 to March 3, 2025, marking a key moment for Jasper Therapeutics as it shares new clinical insights into briquilimab’s performance and its future role in addressing mast cell-related conditions.

Positive Data - January 8,2025

Phase 1b/2a

• Drug: Briquilimab
• Announced Date: January 8, 2025
• Indication: To address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU)

Jasper Therapeutics today reported positive preliminary data from Jasper's ongoing BEACON Phase 1b/2a study of subcutaneous briquilimab in adult participants with CSU. Substantial reductions in UAS7 were reported, with a mean change from baseline at 8 weeks of -26.6 in the 240mg single-dose cohort and multiple dosing regimens at or above 120mg demonstrating UAS7 changes of more than -25 points.

Jasper Therapeutics announced positive preliminary results from its ongoing BEACON Phase 1b/2a study of subcutaneous briquilimab in adults with chronic spontaneous urticaria (CSU). In the study, a single 240mg dose produced a mean reduction of 26.6 points in the Urticaria Activity Score over 7 days (UAS7) at 8 weeks. Additionally, multiple dosing regimens at doses of 120mg and above showed UAS7 reductions of more than 25 points, indicating rapid and significant symptom relief.

The early data also revealed deep and durable clinical responses, with 100% of patients in the 240mg single-dose cohort achieving complete responses (UAS7 = 0) at 8 weeks. These promising results, along with a favorable safety profile, support moving briquilimab forward into a registrational program planned to start in the second half of 2025.

Data Presentation - January 6,2025

• Drug: Briquilimab
• Announced Date: January 6, 2025
• Target Action Date: January 8, 2025
• Indication: To address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU)

Jasper Therapeutics, announced that Jasper will host a virtual webinar on Wednesday, January 8, 2025, to present preliminary data from the BEACON study of briquilimab in CSU.

Jasper Therapeutics has announced that it will host a virtual webinar on Wednesday, January 8, 2025, at 8:00am EST. During this online event, the company will present preliminary data from the BEACON study, which focuses on briquilimab for the treatment of chronic spontaneous urticaria (CSU). The webinar will feature discussion led by Jasper’s management team along with remarks from Dr. Thomas B. Casale, a Professor of Medicine and Pediatrics at the University of South Florida Morsani College of Medicine and lead US investigator in the BEACON study.

Briquilimab, the therapy under study, targets mast cell driven diseases by blocking the c-Kit receptor (CD117). This session is expected to provide important insights into the early-stage data and potential future applications for briquilimab in treating CSU.

Dose Update - December 2,2024

Phase 1b/2a

• Drug: Briquilimab
• Announced Date: December 2, 2024
• Indication: To address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU)

Jasper Therapeutics, announced that the first patient has been dosed in Jasper's Phase 1b/2a clinical challenge study evaluating briquilimab in allergic asthma, called ETESIAN (Evaluating The Efficacy and Safety of briquilimab In participANts with allergic asthma).

Jasper Therapeutics has dosed the first patient in its Phase 1b/2a ETESIAN clinical challenge study, which is investigating briquilimab as a treatment for allergic asthma. In this study, a single 180mg subcutaneous dose of briquilimab is administered to help deplete mast cells in the airways, aiming to provide long-lasting clinical benefits for patients. The double-blind, placebo-controlled trial is designed to enroll about 30 patients across up to seven sites in Canada. Researchers will evaluate key endpoints, including early and late asthmatic responses, changes in airway hyperresponsiveness, mast cell depletion and recovery, as well as the overall safety of the therapy. Jasper Therapeutics plans to share initial data in the second half of 2025, marking an important milestone in advancing a novel treatment option for patients suffering from allergic asthma.

Regulatory Update - September 10,2024

Phase 1b/2a

• Drug: Briquilimab
• Announced Date: September 10, 2024
• Indication: To address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU)

Jasper Therapeutics, announced that Health Canada has cleared the Company's Clinical Trial Application (CTA) for a Phase 1b/2a asthma challenge study evaluating briquilimab in asthma.

Jasper Therapeutics announced that Health Canada has cleared its Clinical Trial Application for a Phase 1b/2a asthma challenge study evaluating briquilimab. This trial is designed as a single-dose, double-blind, placebo-controlled study, and it will be conducted at up to 10 sites across Canada and the European Union. Approximately 30 patients with allergic asthma are expected to participate, receiving a 180mg subcutaneous dose of briquilimab.

The study will assess both early and late asthmatic responses, changes in airway hyperresponsiveness, mast cell depletion and recovery, as well as safety. Jasper aims to show that depleting mast cells in the airways can provide lasting benefits for asthma patients. Patient dosing is anticipated to begin in the fourth quarter of 2024, with initial data expected in the second half of 2025. This milestone is a key advancement in developing briquilimab for mast cell–driven diseases.