FDA Events for Jade Biosciences (JBIO)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Jade Biosciences (JBIO).
Over the past two years, Jade Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
JADE101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
JADE101 - FDA Regulatory Timeline and Events
JADE101 is a drug developed by Jade Biosciences for the following indication: For the treatment of IgA nephropathy (IgAN).
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:
- JADE101
- Announced Date:
- June 9, 2025
- Indication:
- For the treatment of IgA nephropathy (IgAN)
Announcement
Jade Biosciences, Inc announced a detailed preclinical characterization of JADE101, its anti-A Proliferation-Inducing Ligand (APRIL) monoclonal antibody, in development for IgA nephropathy (IgAN), a chronic autoimmune kidney disease.
AI Summary
Jade Biosciences, Inc. announced detailed preclinical results for its JADE101, an anti-APRIL monoclonal antibody in development for treating IgA nephropathy, a chronic autoimmune kidney disease. The study showed that JADE101 binds to APRIL with femtomolar affinity, which could allow it to completely suppress APRIL even at low drug levels. In non-human primates, a single dose resulted in a 27-day half-life and produced deep, sustained reductions in IgA for over 100 days. These findings suggest that JADE101 could support subcutaneous dosing every eight weeks or longer, making the treatment more convenient for patients. The promising preclinical profile sets the stage for a first-in-human trial scheduled for the second half of 2025, with biomarker-rich interim data expected in the first half of 2026 to help guide dose and schedule decisions.
Read Announcement- Drug:
- JADE101
- Announced Date:
- June 2, 2025
- Indication:
- For the treatment of IgA nephropathy (IgAN)
Announcement
Jade Biosciences, Inc.announced new preclinical data on JADE101, its anti-APRIL monoclonal antibody being developed for the treatment of IgA nephropathy (IgAN), will be presented in an oral session during the 62nd European Renal Association (ERA) Congress, taking place in Vienna from June 4-7, 2025.
AI Summary
Jade Biosciences, Inc. has announced new preclinical data on its investigational therapy, JADE101, an anti-APRIL monoclonal antibody being developed for IgA nephropathy (IgAN). The data will be presented during an oral session at the 62nd European Renal Association (ERA) Congress in Vienna, Austria, from June 4‑7, 2025.
The session, titled “Discovery and Characterization of JADE101, an Ultra‑High Affinity, Half‑Life Extended Anti‑APRIL Monoclonal Antibody for the Treatment of IgAN,” will feature Erin Filbert, the Executive Director and Head of Research and Translational Medicine at Jade Biosciences. This presentation will focus on glomerular and tubulo‑interstitial diseases, highlighting the potential of JADE101 to reduce pathogenic IgA levels and preserve kidney function in patients suffering from IgAN.
Read Announcement
Jade Biosciences FDA Events - Frequently Asked Questions
As of now, Jade Biosciences (JBIO) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Jade Biosciences (JBIO) has reported FDA regulatory activity for JADE101.
The most recent FDA-related event for Jade Biosciences occurred on June 9, 2025, involving JADE101. The update was categorized as "Preclinical characterization," with the company reporting: "Jade Biosciences, Inc announced a detailed preclinical characterization of JADE101, its anti-A Proliferation-Inducing Ligand (APRIL) monoclonal antibody, in development for IgA nephropathy (IgAN), a chronic autoimmune kidney disease."
Currently, Jade Biosciences has one therapy (JADE101) targeting the following condition: For the treatment of IgA nephropathy (IgAN).
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:JBIO) was last updated on 7/13/2025 by MarketBeat.com Staff
