regulatory
confidence high
sentiment positive
materiality 0.90
Aura Biosciences Receives FDA SPA Agreement for CoMpass Phase 3 Trial of Bel-sar in Choroidal Melanoma
Aura Biosciences, Inc.
- 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.