FDA Events for Jasper Therapeutics (JSPR)
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.
- 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)
Announcement
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.
AI Summary
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.
Read Announcement- 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)
Announcement
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.
AI Summary
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.
Read Announcement- 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)
Announcement
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.
AI Summary
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.
Read Announcement- 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)
Announcement
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.
AI Summary
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.
Read Announcement- 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)
Announcement
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.
AI Summary
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.
Read Announcement- Drug:
- Briquilimab
- Announced Date:
- January 6, 2025
- Estimated Event Date Range:
- January 8, 2025 - January 8, 2025
- Target Action Date:
- January 08, 2025
- Indication:
- To address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU)
Announcement
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.
AI Summary
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.
Read Announcement- 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)
Announcement
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).
AI Summary
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.
Read Announcement- 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)
Announcement
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.
AI Summary
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.
Read Announcement
Jasper Therapeutics FDA Events - Frequently Asked Questions
As of now, Jasper Therapeutics (JSPR) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Jasper Therapeutics (JSPR) has reported FDA regulatory activity for Briquilimab.
The most recent FDA-related event for Jasper Therapeutics occurred on July 7, 2025, involving Briquilimab. The update was categorized as "Updated data," with the company reporting: "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."
Currently, Jasper Therapeutics has one therapy (Briquilimab) targeting the following condition: To address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU).
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:JSPR) was last updated on 7/12/2025 by MarketBeat.com Staff
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