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Aura Biosciences, Inc. (symbol: AURA) is a clinical-stage biotechnology company revolutionizing cancer treatment through the development of precision immunotherapies. The company's pioneering approach, known as molecular surgery, targets and destroys cancer cells selectively while sparing the surrounding healthy tissue. This method holds promise in treating various cancers, particularly those that are challenging to manage with current therapies.
Aura Biosciences' lead program focuses on ocular melanoma (OM), also known as choroidal or uveal melanoma. This innovative therapy aims to eliminate cancer cells in the eye as a first-line treatment, with the potential to preserve patients' vision. By addressing the cancer early, Aura Biosciences seeks to prevent the disease from progressing and metastasizing to other organs such as the liver, where it often becomes fatal.
In addition to OM, the company's lead candidate, bel-sar, is in early-stage clinical development for bladder cancer and other ocular oncology indications. This first-in-class, non-radioactive treatment offers a novel approach to precisely target and eradicate cancer cells.
Aura Biosciences is also exploring treatments for cancers of the ocular surface, affecting approximately 35,000 patients in the United States and Europe annually. Positive preclinical data for bel-sar in this indication were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting.
Recently, the company strengthened its leadership team with the appointment of Conor Kilroy as General Counsel and Secretary, further solidifying its strategic vision and operational capabilities.
Operating exclusively in the United States, Aura Biosciences is committed to advancing its clinical programs and bringing transformative cancer therapies to patients worldwide.
Aura Biosciences, Inc. (NASDAQ: AURA) announced an underwritten public offering of its common stock, with all shares being offered by the company. The offering is subject to market conditions, and underwriters may purchase an additional 15% of shares. The offering follows a shelf registration statement filed with the SEC. Aura is focused on developing virus-like drug conjugate therapies for various oncology indications, including a global Phase 3 trial for treating choroidal melanoma.
Aura Biosciences reported its Q3 2022 financial results, highlighting significant clinical advancements in its oncology programs. The company announced the global Phase 3 trial design for belzupacap sarotalocan in treating early-stage choroidal melanoma, marking a milestone in vision-preserving therapy. A first patient has been dosed in a Phase 1 study for non-muscle invasive bladder cancer. Financially, Aura’s cash position is $111.5 million, expected to fund operations until 2024. However, R&D and G&A expenses have increased, leading to a net loss of $15.9 million for Q3 2022.
Aura Biosciences Inc. (NASDAQ: AURA) has announced the initiation of startup activities for a global Phase 3 trial for its drug belzupacap sarotalocan (bel-sar), aimed at treating early-stage choroidal melanoma. This follows positive interim data from a Phase 2 trial presented at the American Academy of Ophthalmology. The trial will evaluate bel-sar's safety and efficacy compared to a sham treatment. Approximately 75 patients will be enrolled, with a focus on those with documented tumor growth to enhance trial efficiency.
Aura Biosciences (NASDAQ: AURA), a clinical-stage biotechnology company, announced participation in key investor conferences. The executive team will present at the Stifel 2022 Healthcare Conference on November 16, 2022, at 10:55 a.m. ET, and hold a fireside chat at the 5th Annual 2022 Evercore ISI HealthCONx on November 29, 2022, at 8:25 a.m. ET. Webcasts of both events will be accessible on the company’s website for 90 days post-event. Aura specializes in virus-like drug conjugates for various oncology treatments, including ocular cancers.
Aura Biosciences (NASDAQ: AURA) announced encouraging interim Phase 2 data for its first virus-like drug conjugate, belzupacap sarotalocan (AU-011), targeting early-stage choroidal melanoma. The data, presented at the American Academy of Ophthalmology 2022 Annual Meeting, showed a significant reduction in tumor growth rates (-0.296 mm/yr, p = 0.0007) and an 88.9% tumor control rate after three cycles of treatment. The therapy demonstrated favorable safety and a potential for vision preservation in patients lacking treatment options. A virtual Investor Day was scheduled to discuss these findings further.
Aura Biosciences Inc. (NASDAQ: AURA) has announced the dosing of the first patient in a Phase 1 clinical trial of belzupacap sarotalocan, aimed at treating Non-Muscle Invasive Bladder Cancer (NMIBC). This trial marks a significant milestone in urologic oncology, addressing a high unmet medical need. The trial will enroll 23 patients to evaluate the safety and tolerability of the treatment. Previously, the FDA granted Fast Track designation for this candidate, facilitating more frequent consultations regarding its clinical development.
Aura Biosciences (NASDAQ: AURA) will present data from its Phase 2 trial for belzupacap sarotalocan (AU-011) at the American Academy of Ophthalmology (AAO) Annual Meeting, running from September 30 to October 3, 2022. The trial targets early-stage choroidal melanoma. A virtual Investor Day is scheduled for October 3, featuring discussions with ocular oncology experts about safety, efficacy results, and potential combinations with immune checkpoint inhibitors. The company aims to develop AU-011 for various oncology treatments, including ocular cancers.
Aura Biosciences Inc. (NASDAQ: AURA) recently announced that Phase 2 data for its first virus-like drug conjugate (VDC), belzupacap sarotalocan (AU-011), will be presented at the ESMO 2022 Congress, taking place from September 9-13 in Paris. The presentation will focus on the safety of suprachoroidal administration for treating early-stage choroidal melanoma. The company aims to enhance treatment options for this severe form of eye cancer, currently in a dose escalation trial. Additional developments are planned for other oncology applications.
Aura Biosciences Inc. (NASDAQ: AURA) announced recent advancements in its leading candidate, belzupacap sarotalocan (AU-011), aimed at treating early-stage choroidal melanoma. Presentations at the EURETINA Congress will showcase interim safety results from a Phase 2 trial and final efficacy data from a Phase 1b/2 trial. The ongoing development focuses on both choroidal melanoma and its metastatic counterpart. Aura plans to submit an IND for choroidal metastases in the second half of 2022, emphasizing the drug's potential in ocular oncology.
Aura Biosciences (NASDAQ: AURA) reported significant advancements in its clinical pipeline for belzupacap sarotalocan, aiming to treat non-muscle invasive bladder cancer (NMIBC) and early-stage choroidal melanoma. The company is set to dose the first patient in the Phase 1 trial for NMIBC in Q3 2022 and initiate a pivotal trial for choroidal melanoma in Q4 2022. Aura received FDA Fast Track designation for NMIBC, enhancing its development strategy. Financially, the company reported a net loss of $13.5 million for Q2 2022, with cash reserves expected to fund operations into 2024.
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