FDA Events for Vera Therapeutics (VERA)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Vera Therapeutics (VERA).
Over the past two years, Vera Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Atacicept. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Atacicept - FDA Regulatory Timeline and Events
Atacicept is a drug developed by Vera Therapeutics for the following indication: Patients with 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:
- Atacicept
- Announced Date:
- June 2, 2025
- Indication:
- Patients with IgAN
Announcement
Vera Therapeutics, Inc. announced that the primary endpoint was met in the ORIGIN Phase 3 trial of atacicept for the treatment of immunoglobulin A nephropathy (IgAN) in adults.
AI Summary
Vera Therapeutics, Inc. announced that the primary endpoint was met in the ORIGIN Phase 3 trial of atacicept for treating immunoglobulin A nephropathy (IgAN) in adults. The trial showed a 46% reduction in proteinuria from baseline and a 42% reduction compared to placebo at week 36, with highly statistically significant results (p<0.0001). Other prespecified endpoints also met or exceeded previous trial outcomes. The safety profile of atacicept was similar to placebo, adding confidence to the findings.
Vera plans to discuss these promising results with the FDA in the coming weeks. The company is on track to submit a Biologics License Application for an accelerated approval in the fourth quarter of 2025. While the ORIGIN 3 trial continues with further investigation of kidney function over two years, these positive interim results highlight atacicept’s potential to become a leading treatment option for IgAN.
Read Announcement- Drug:
- Atacicept
- Announced Date:
- April 3, 2025
- Indication:
- Patients with IgAN
Announcement
Vera Therapeutics, Inc announced that it has completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept in patients with IgA Nephropathy (IgAN).
AI Summary
Vera Therapeutics has reached a major milestone by completing full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept for patients with IgA Nephropathy (IgAN). The trial enrolled a total of 431 participants who have persistent proteinuria, a key indicator of disease progression, to assess whether atacicept can reduce kidney damage by targeting the BAFF and APRIL pathways.
The study involves self-administered, once-weekly subcutaneous injections over a 104-week period, with primary efficacy measured by the change in proteinuria at 36 weeks. Vera Therapeutics plans to announce the primary endpoint results later this quarter and is preparing to submit a Biologics License Application for accelerated approval to the FDA in the second half of 2025. This development marks an important step toward providing a novel treatment option for patients with IgAN.
Read Announcement- Drug:
- Atacicept
- Announced Date:
- October 2, 2024
- Indication:
- Patients with IgAN
Announcement
Vera Therapeutics, Inc announced that long-term results from the ORIGIN Phase 2b clinical trial of atacicept for the treatment of IgAN will be delivered in a late-breaking oral presentation, and two informational posters will describe the ORIGIN Phase 3 and ORIGIN Extend trials, at the American Society of Nephrology (ASN) Kidney Week 2024 in San Diego, California, from October 23 to 27.
AI Summary
Vera Therapeutics, Inc. announced key updates to its atacicept clinical program for treating IgA nephropathy (IgAN) at the American Society of Nephrology Kidney Week 2024 in San Diego, California, from October 23 to 27. The company will present long-term results from the ORIGIN Phase 2b trial in a late-breaking oral presentation, emphasizing atacicept’s potential as a disease-modifying treatment for IgAN. In addition, two informational posters will be showcased detailing the ORIGIN Phase 3 and ORIGIN Extend trials. The ORIGIN Extend trial aims to provide extended access to atacicept for participants before the treatment becomes commercially available in their region. These presentations underline Vera Therapeutics’ commitment to advancing clinical research and enhancing treatment options for patients with IgAN, offering further insights into the long-term efficacy and safety of atacicept in managing this kidney disease.
Read Announcement- Drug:
- Atacicept
- Announced Date:
- September 12, 2024
- Indication:
- Patients with IgAN
Announcement
Vera Therapeutics, Inc. announced that it has completed enrollment ahead of schedule for the primary endpoint in the pivotal Phase 3 ORIGIN 3 trial of atacicept in patients with IgAN.
AI Summary
Vera Therapeutics, Inc. has reached a key milestone in its study of atacicept for IgA Nephropathy (IgAN). The company announced that it completed enrollment ahead of schedule for the pivotal Phase 3 ORIGIN 3 trial's primary endpoint. In this trial, 200 patients were successfully enrolled in the initial cohort, which will provide data for the 36-week UPCR efficacy endpoint. The goal of the trial is to evaluate atacicept’s safety and effectiveness in reducing proteinuria and preserving kidney function in IgAN patients who remain at high risk of disease progression.
Topline results from the trial are expected in the second quarter of 2025, paving the way for further regulatory submissions. This accelerated enrollment reflects strong support from investigators and patients, highlighting the clinical interest in atacicept as a potential new treatment option for IgAN.
Read Announcement- Drug:
- Atacicept
- Announced Date:
- September 12, 2024
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 2025
- Indication:
- Patients with IgAN
Announcement
Vera Therapeutics, Inc announced that On track to announce topline results from ORIGIN 3 trial in Q2 2025.
AI Summary
Vera Therapeutics, Inc. announced that it is on track to deliver topline results for its pivotal Phase 3 ORIGIN 3 clinical trial in the second quarter of 2025. This study evaluates the efficacy and safety of atacicept in patients with IgA nephropathy (IgAN) who remain at high risk of disease progression. The trial has successfully enrolled 200 participants ahead of schedule for its primary endpoint, which focuses on proteinuria reduction. This successful enrollment is a crucial step toward supporting future regulatory submissions and advancing a potentially transformative treatment for IgAN.
The company is also set to present long-term data from its Phase 2b ORIGIN trial, with 96-week results expected in the fourth quarter of 2024. These findings could provide further insights into atacicept’s ability to stabilize kidney function and reduce critical markers of the disease, reinforcing its promise as an innovative therapy for patients.
Read Announcement - Drug:
- Atacicept
- Announced Date:
- September 12, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- Patients with IgAN
Announcement
Vera Therapeutics, Inc. announced that Expect to present 96-week data from ORIGIN Phase 2b clinical trial of atacicept in IgAN in Q4 2024
AI Summary
Vera Therapeutics, Inc. announced that it plans to present 96‐week data from its ORIGIN Phase 2b trial of atacicept in patients with IgA nephropathy (IgAN) in the fourth quarter of 2024. This long-term clinical data will help provide further insights into the drug’s effectiveness and safety in reducing proteinuria and stabilizing kidney function over an extended treatment period. Early data from the trial have shown promise, including significant reductions in proteinuria and improvements in key kidney function measures. The upcoming presentation is considered an important milestone for the company as it continues to explore atacicept as a potential transformative treatment for IgAN. Vera Therapeutics is working diligently to advance clinical results that may offer more treatment options for patients who are at high risk of disease progression and could benefit from a new approach to managing this serious condition.
Read Announcement- Drug:
- Atacicept
- Announced Date:
- May 28, 2024
- Indication:
- Patients with IgAN
Announcement
Vera Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to atacicept for the treatment of IgAN.
AI Summary
Vera Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to atacicept for the treatment of IgA nephropathy (IgAN), a serious kidney disease. This designation was based on promising results from the Phase 2b ORIGIN trial, which demonstrated that atacicept helped stabilize kidney function—as shown by improvements in the estimated glomerular filtration rate (eGFR)—compared to the current therapies.
This FDA recognition is important as it could speed up the development and review process, allowing atacicept to reach patients faster. Vera Therapeutics is optimistic that atacicept can transform IgAN treatment and is preparing to share long-term trial data later this year, with additional Phase 3 results expected in the first half of 2025. The agency’s decision highlights the drug’s potential to offer a significant improvement in managing this progressive disease.
Read Announcement
Vera Therapeutics FDA Events - Frequently Asked Questions
As of now, Vera Therapeutics (VERA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Vera Therapeutics (VERA) has reported FDA regulatory activity for Atacicept.
The most recent FDA-related event for Vera Therapeutics occurred on June 2, 2025, involving Atacicept. The update was categorized as "Primary endpoint Met," with the company reporting: "Vera Therapeutics, Inc. announced that the primary endpoint was met in the ORIGIN Phase 3 trial of atacicept for the treatment of immunoglobulin A nephropathy (IgAN) in adults."
Currently, Vera Therapeutics has one therapy (Atacicept) targeting the following condition: Patients with 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:VERA) was last updated on 7/12/2025 by MarketBeat.com Staff
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