secwatch.observer — SEC 8-K summary
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Issuer:     Aura Biosciences, Inc. (AURA)
CIK:        0001501796
Form:       8-K
Filed at:   2022-06-22T23:59:59+00:00
Accession:  0001193125-22-178857
Event type: other_material
Sentiment:  positive
Materiality: 0.72
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Aura Biosciences reports positive retrospective data for AU-011 in choroidal melanoma vs. radiotherapy
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- Belzupacap sarotalocan showed statistically significant vision preservation at 2 years vs. plaque radiotherapy (logMAR p=0.0094).
- Radiotherapy patients lost ≥3 lines of vision in a majority by 2 years; ≥6 lines by 3 years.
- Data from 43 AU-011 patients vs. 150 matched radiotherapy controls (tumor edge within 3.0 mm of fovea).
- Mean follow-up for AU-011 was 15.6 months; study is retrospective and hypothesis-generating.
- Phase 2 trial (suprachoroidal) ongoing; pivotal trial expected to initiate by end of 2022.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1501796/000119312522178857/0001193125-22-178857-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1501796/000119312522178857/d292968d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-178857

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