FDA Events for Aura Biosciences (AURA)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Aura Biosciences (AURA).
Over the past two years, Aura Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AU-011. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AU-011 - FDA Regulatory Timeline and Events
AU-011 is a drug developed by Aura Biosciences for the following indication: Uveal Melanoma (Includes Choroidal Melanoma).
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:
- AU-011
- Announced Date:
- March 24, 2025
- Indication:
- Uveal Melanoma (Includes Choroidal Melanoma)
Announcement
Aura Biosciences, Inc. announced positive data from a completed Phase 1 window of opportunity trial of bel-sar (AU-011) in patients with NMIBC.
AI Summary
Aura Biosciences, Inc. announced positive data from its completed Phase 1 window of opportunity trial of bel-sar (AU-011) in patients with non-muscle invasive bladder cancer (NMIBC). The trial assessed the safety and clinical activity of a single low dose of bel-sar, administered with light activation, in both intermediate- and high-risk NMIBC patients. Notably, in the intermediate-risk subgroup, 4 out of 5 patients showed a clinical complete response, with no tumor cells found on histopathological evaluation, while several patients exhibited tumor shrinkage observed during cystoscopy. The treatment also produced robust cell-mediated immune responses, with significant infiltration of CD8+ and CD4+ T-cells in the tumor microenvironment, suggesting an induced immune-driven urothelial field effect. The favorable safety profile—with only minimal Grade 1 drug-related adverse events—underscores its potential as a paradigm shifting, front-line treatment option for NMIBC. Future Phase 1b/2 trials are planned to further assess its efficacy.
Read Announcement- Drug:
- AU-011
- Announced Date:
- March 3, 2025
- Indication:
- Uveal Melanoma (Includes Choroidal Melanoma)
Announcement
Aura Biosciences, Inc. announced that additional Phase 1 data evaluating bel-sar (AU-011) for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) will be presented at the 40th Annual European Association of Urology (EAU) Congress being held March 21-24, 2025, in Madrid, Spain.
AI Summary
Aura Biosciences, Inc. announced that additional Phase 1 data for bel-sar (AU-011) in treating non-muscle invasive bladder cancer (NMIBC) will be presented at the 40th Annual European Association of Urology Congress. The event will take place in Madrid, Spain, from March 21 to 24, 2025. During the congress, Aura will participate in the EAU Research Forum where late-breaker results on the safety and efficacy of bel-sar will be shared. The Phase 1 trial is an open-label, multi-center study that assesses the feasibility and safety of using bel-sar as a pre-surgical treatment before the standard transurethral resection of bladder tumor (TURBT). The presentation aims to highlight bel-sar’s biological activity, its dual mechanism of action, and its role in triggering an immune response, potentially paving the way for improved treatment strategies in bladder cancer care.
Read Announcement- Drug:
- AU-011
- Announced Date:
- September 12, 2024
- Indication:
- Uveal Melanoma (Includes Choroidal Melanoma)
Announcement
Aura Biosciences, Inc. announced positive Phase 2 end of study results evaluating bel-sar (AU-011) for the first-line treatment of early-stage choroidal melanoma (CM), a vision and life-threatening ocular cancer.
AI Summary
Aura Biosciences, Inc. announced promising Phase 2 study results for bel-sar (AU-011) as a first-line treatment for early-stage choroidal melanoma, a serious ocular cancer. The study showed an 80% tumor control rate among eligible patients, with responders experiencing a near complete halt in tumor growth. In addition, the treatment preserved visual acuity in 90% of patients, even among those at high risk for vision loss due to proximity to critical eye structures such as the fovea or optic disc.
The trial, which included 22 patients and monitored them over 12 months, also demonstrated a highly favorable safety profile with no treatment-related serious adverse events. These results highlight bel-sar’s potential as a first-in-class therapy that effectively manages tumor growth while preserving vision, a significant advance compared to the current standard care that often leads to severe visual impairment.
Read Announcement
Aura Biosciences FDA Events - Frequently Asked Questions
As of now, Aura Biosciences (AURA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Aura Biosciences (AURA) has reported FDA regulatory activity for AU-011.
The most recent FDA-related event for Aura Biosciences occurred on March 24, 2025, involving AU-011. The update was categorized as "Positive Data," with the company reporting: "Aura Biosciences, Inc. announced positive data from a completed Phase 1 window of opportunity trial of bel-sar (AU-011) in patients with NMIBC."
Currently, Aura Biosciences has one therapy (AU-011) targeting the following condition: Uveal Melanoma (Includes Choroidal Melanoma).
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:AURA) was last updated on 7/12/2025 by MarketBeat.com Staff
