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Jasper Therapeutics (JSPR) FDA Events

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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.

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

  • 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 7/10/2025 by MarketBeat.com Staff
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