---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-271351"
form_type: "8-K"
ticker: "AURA"
cik: "0001501796"
company_name: "Aura Biosciences, Inc."
filed_at: "2023-11-06T23:59:59+00:00"
generated_at: "2026-06-08T19:46:23.385384+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Aura Biosciences Receives FDA SPA Agreement for CoMpass Phase 3 Trial of Bel-sar in Choroidal Melanoma

## Summary
- FDA agreed under Special Protocol Assessment to design and planned analysis of CoMpass Phase 3 trial for bel-sar in early-stage choroidal melanoma.
- Phase 2 data with 90% follow-up at 12 months showed 80% tumor control and 90% visual acuity preservation in patients meeting Phase 3 criteria.
- Preliminary Phase 1 bladder cancer data: first patient with light activation achieved clinical complete response with extensive necrosis and immune activation.
- Company terminated ATM equity offering program with Jefferies, suspending sales under existing prospectus.

## SEC filing metadata
- accession: 0001193125-23-271351
- form_type: 8-K
- ticker: AURA
- cik: 0001501796
- company_name: Aura Biosciences, Inc.
- filed_at: 2023-11-06T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1501796/000119312523271351/0001193125-23-271351-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1501796/000119312523271351/d471944d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-271351
- JSON: https://secwatch.observer/filing/0001193125-23-271351.json
- Plain text: https://secwatch.observer/filing/0001193125-23-271351.txt

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