FDA Events for Zenas BioPharma (ZBIO)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Zenas BioPharma (ZBIO).
Over the past two years, Zenas BioPharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Obexelimab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Obexelimab - FDA Regulatory Timeline and Events
Obexelimab is a drug developed by Zenas BioPharma for the following indication: Immunoglobulin G4-Related Disease (IgG4-RD).
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:
- Obexelimab
- Announced Date:
- February 5, 2025
- Indication:
- Immunoglobulin G4-Related Disease (IgG4-RD)
Announcement
Zenas BioPharma, Inc announced its 2024 accomplishments, outlined its key business objectives for 2025 and announced preliminary unaudited cash balance as of year-end 2024.
AI Summary
Zenas BioPharma, Inc. announced key milestones from 2024 and shared important goals for 2025. The company highlighted its accomplishments this past year as it advanced multiple clinical trials of its lead product candidate, obexelimab, for treating autoimmune diseases. For 2025, Zenas plans to hit major value-driving targets, including pivotal Phase 2 and Phase 3 trial results. The company is preparing for topline data from its Phase 2 trial in relapsing multiple sclerosis and Phase 3 trial in IgG4-related disease by the end of 2025. Additionally, the enrollment for a Phase 2 trial in systemic lupus erythematosus is expected to complete in 2025. Zenas also announced that its preliminary unaudited cash balance stands at roughly $350 million at the end of 2024, which is expected to fund operations and capital needs through the fourth quarter of 2026.
Read Announcement
Zenas BioPharma FDA Events - Frequently Asked Questions
As of now, Zenas BioPharma (ZBIO) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Zenas BioPharma (ZBIO) has reported FDA regulatory activity for Obexelimab.
The most recent FDA-related event for Zenas BioPharma occurred on February 5, 2025, involving Obexelimab. The update was categorized as "Clinical Update," with the company reporting: "Zenas BioPharma, Inc announced its 2024 accomplishments, outlined its key business objectives for 2025 and announced preliminary unaudited cash balance as of year-end 2024."
Currently, Zenas BioPharma has one therapy (Obexelimab) targeting the following condition: Immunoglobulin G4-Related Disease (IgG4-RD).
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:ZBIO) was last updated on 7/14/2025 by MarketBeat.com Staff
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