secwatch.observer — SEC 8-K summary
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Issuer:     Aura Biosciences, Inc. (AURA)
CIK:        0001501796
Form:       8-K
Filed at:   2023-11-06T23:59:59+00:00
Accession:  0001193125-23-271351
Event type: regulatory
Sentiment:  positive
Materiality: 0.90
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1501796/000119312523271351/0001193125-23-271351-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1501796/000119312523271351/d471944d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-271351

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer