Aura Biosciences Receives FDA Agreement Under Special Protocol Assessment For CoMpass Phase 3 Clinical Trial Of Belzupacap Sarotalocan In Early-Stage Choroidal Melanoma
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Aura Biosciences, Inc. (NASDAQ:AURA) has received agreement from the U.S. Food and Drug Administration (FDA) for the design and planned analysis of its global Phase 3 clinical trial of bel-sar for the first-line treatment of adult patients with early-stage choroidal melanoma. The company also presented positive Phase 2 safety and efficacy data of bel-sar with 90% of patients at twelve months of follow-up showing tumor control and visual acuity preservation. Preliminary data from a Phase 1 trial in bladder cancer showed a clinical complete response in the first patient using a single dose of bel-sar with light activation.

November 06, 2023 | 8:01 pm
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Aura Biosciences has received FDA agreement for its Phase 3 clinical trial of bel-sar, a treatment for early-stage choroidal melanoma. Positive Phase 2 data and promising preliminary results from a Phase 1 trial in bladder cancer were also announced.
The FDA agreement for the Phase 3 trial of bel-sar is a significant regulatory milestone for Aura Biosciences. The positive Phase 2 data and promising preliminary results from the Phase 1 trial in bladder cancer further validate the potential of bel-sar, which could positively impact Aura's stock in the short term.
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