Aura Biosciences, Inc. AURA
Aura Biosciences, Inc. (Nasdaq: AURA) is an oncology drug developer. Its lead program, bel-sar (belzupacap sarotalocan), is in Phase 3 for Early choroidal melanoma.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| bel-sar (CoMpass trial) | Early choroidal melanoma | biologic-other | Phase 3 |
| bel-sar | Metastases to the choroid | biologic-other | Phase 2 |
| bel-sar | Non-muscle invasive bladder cancer (Phase 1b/2 dose escalation) | biologic-other | Phase 2 |
| bel-sar | Cancers of the ocular surface | biologic-other | Phase 1 |
Recent results and decisions
- Aug 11, 2026completed enrollment Phase 3 CoMpass fully enrolled with 108 patients, exceeding the enrollment target.
The Phase 3 CoMpass trial, the first registration-enabling study in patients with early choroidal melanoma, is fully enrolled with 108 patients, which exceeded the enrollment target.
Filing - Aug 11, 2026positive Interim Phase 1b/2 NMIBC data in 16 intermediate-risk patients: 81% objective response and 69% complete response at 3 months; all evaluable patients at 9 and 12 months disease-free; Grade 1 TRAEs only. Program being deprioritized.
Among intermediate-risk patients treated with bel-sar alone (n=8) or with TURBT (n=8), 81% of patients achieved an objective response at 3 months, including 69% with a complete response at that timepoint.
Filing - Nov 13, 2025positive Phase 1 NMIBC immune profiling (SIU): single focal bel-sar dose induced tertiary lymphoid structures in 3 of 5 evaluated participants, with up to 40x NK cell density increase.
These data revealed that a single focal administration of bel-sar induced adaptive immune memory through generation of de novo mature tertiary lymphoid structures (TLS) in 3/5 participants evaluated.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
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- Companies on the same target or class
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- BeOne Medicines Ltd. ONC
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- Genmab A/S GMAB
- BioNTech SE BNTX
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.