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Aura Biosciences, Inc. develops precision therapies for solid tumors designed to preserve organ function. The clinical-stage biotechnology company’s recurring updates center on bel-sar (AU-011), its lead candidate in late-stage development for early choroidal melanoma and in early-stage development for other ocular oncology indications and bladder cancer.
Company news also covers financial results, clinical-program business highlights, investor conference participation, executive leadership changes, and capital actions involving common stock and pre-funded warrants. Aura’s disclosures frequently connect pipeline progress with oncology indications, trial activity, liquidity planning, and governance developments.
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Aura Biosciences (NASDAQ: AURA) announced FDA Fast Track Designation for belzupacap sarotalocan (bel-sar) to treat choroidal metastasis, signifying a significant opportunity for a new standard of care. Following positive Phase 2 results for early-stage choroidal melanoma, the global Phase 3 trial is set to begin dosing in 1H 2023. Financial results reveal a cash position of $188.8 million, sufficient to fund operations into 2025.
However, R&D expenses surged to $42.2 million, contributing to a net loss of $58.8 million for the year.
Aura Biosciences, Inc. (Nasdaq: AURA) announced positive interim Phase 2 safety and efficacy data for its treatment, bel-sar, aimed at early-stage choroidal melanoma. Results showed an impressive 100% tumor control rate and an 88% visual acuity preservation rate after an average of nine months follow-up in patients. The therapy demonstrated favorable safety, with only one case of visual acuity loss and no serious adverse events reported. Aura plans to initiate a global Phase 3 trial this year, bolstering confidence in bel-sar's potential as a first-line treatment. These results were presented at the Macula Society’s 46th Annual Meeting in Miami, FL.
Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotech firm, focuses on developing virus-like drug conjugate (VDC) therapies for oncology. CEO Elisabet de los Pinos will present at the SVB Securities Global Biopharma Conference on February 16, 2023 at 12:00 p.m. ET and at the 43rd Annual Cowen Healthcare Conference on March 8, 2023, participating in an auditory and ophthalmology panel at 12:50 p.m. ET. These events will be accessible via live webcasts on Aura's website, where replays will be available for 90 days.
Aura's lead VDC candidate, bel-sar, targets ocular cancers and is in a Phase 3 trial for treating early-stage choroidal melanoma.