---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-185580"
form_type: "8-K"
ticker: "AURA"
cik: "0001501796"
company_name: "Aura Biosciences, Inc."
filed_at: "2022-06-30T23:59:59+00:00"
generated_at: "2026-06-24T21:59:18.106752+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Aura Biosciences receives FDA Fast Track for belzupacap sarotalocan in NMIBC; Phase 1 trial H2 2022

## Summary
- FDA granted Fast Track designation for belzupacap sarotalocan (AU-011) for treatment of Non-Muscle Invasive Bladder Cancer.
- NMIBC has no approved targeted therapies; high recurrence and progression often leading to cystectomy.
- Aura plans Phase 1 trial in NMIBC starting H2 2022, with initial data expected in 2023.
- AU-011 previously received Fast Track and Orphan Drug designations for choroidal melanoma, currently in Phase 2.

## SEC filing metadata
- accession: 0001193125-22-185580
- form_type: 8-K
- ticker: AURA
- cik: 0001501796
- company_name: Aura Biosciences, Inc.
- filed_at: 2022-06-30T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1501796/000119312522185580/0001193125-22-185580-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1501796/000119312522185580/d371151d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-185580
- JSON: https://secwatch.observer/filing/0001193125-22-185580.json
- Plain text: https://secwatch.observer/filing/0001193125-22-185580.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.