Welcome to our dedicated page for Aura Biosciences news (Ticker: AURA), a resource for investors and traders seeking the latest updates and insights on Aura Biosciences stock.
Aura Biosciences Inc (AURA) is a clinical-stage biotechnology company developing molecular surgery therapies for cancer treatment, with a lead program targeting ocular melanoma. The company's news feed provides updates on clinical trial results, regulatory developments, and corporate milestones that impact its drug development pipeline.
For biotechnology companies like Aura, news coverage typically centers on clinical trial data releases, FDA interactions, and financing activities. Clinical trial updates are particularly significant, as they reveal whether investigational therapies demonstrate safety and efficacy in patient populations. Positive trial results can validate the company's scientific approach and advance regulatory pathways, while setbacks may require protocol modifications or program adjustments. News about bel-sar, Aura's lead therapy for ocular melanoma, includes data on complete response rates, safety profiles, and progression toward regulatory submissions.
Financial news for Aura Biosciences includes quarterly earnings reports detailing operating expenses, cash positions, and development progress. As a clinical-stage company with no product revenue, these reports provide insight into the company's cash runway and capital requirements. Public offering announcements signal when Aura raises funds to support ongoing trials and operations. Investor conference presentations and analyst updates offer management's perspective on development timelines and strategic priorities.
Regulatory filings and FDA correspondence can provide important context for Aura's development programs. News about clinical trial initiations, patient enrollment milestones, or protocol amendments helps investors track the pace of development. Corporate developments such as key appointments, partnership announcements, or intellectual property updates also appear in the company's news flow. Bookmark this page to track Aura Biosciences' clinical progress, financial updates, and regulatory milestones as the company advances its molecular surgery platform through development.
Aura Biosciences (NASDAQ: AURA) announced positive data from a completed Phase 1 trial of bel-sar in Non-Muscle-Invasive Bladder Cancer (NMIBC) patients. The trial included 15 patients, evaluating safety and feasibility of local bel-sar administration.
Key findings:
- In patients receiving bel-sar with light activation (n=10), 4 out of 5 intermediate-risk patients showed complete clinical response
- In high-risk patients, 1 out of 5 demonstrated complete response, with 3 showing tumor shrinkage
- 57% of patients with multiple tumors showed complete response in non-target tumors
- Safety profile was favorable with only Grade 1 drug-related events in less than 10% of patients
- Significant immune response observed with infiltration of effector cells and formation of tertiary lymphoid structures
The treatment demonstrated potential as a front-line focal treatment approach for NMIBC patients, with administration possible without general anesthesia.
Aura Biosciences (NASDAQ: AURA) has announced that additional Phase 1 data for bel-sar (AU-011) in treating non-muscle invasive bladder cancer (NMIBC) will be presented at the 40th Annual European Association of Urology Congress in Madrid, Spain (March 21-24, 2025).
The late-breaking presentation by Dr. Seth Lerner will focus on the safety and efficacy of Bel-sar, a Virus-like-Drug-Conjugate (VDC). Additionally, a Research Forum will discuss VDCs as a paradigm-shifting approach for bladder cancer treatment.
The ongoing Phase 1 trial is designed as a window of opportunity study evaluating bel-sar as a monotherapy before standard TURBT procedure. The study aims to assess local administration approaches and includes histopathological evaluation after a single dose to examine biological activity and immune response.
Aura will host a virtual urologic oncology investor event on March 24, 2025, featuring key opinion leaders to discuss the trial data and future development plans, including the planned Phase 1b/2 trial expansion.
Aura Biosciences (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors, has announced its participation in two upcoming investor conferences in March 2025.
CEO Elisabet de los Pinos will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Tuesday, March 4, 2025, at 9:10 a.m. ET. She will also attend the Leerink Partners Global Healthcare Conference on Tuesday, March 11, 2025, with a fireside chat scheduled for 8:00 a.m. ET.
Live webcasts of both presentations will be available on the "Investors & Media" page under the "Events & Presentations" section of Aura's website. Replays will remain accessible for 90 days following each presentation.
Aura Biosciences (NASDAQ: AURA) has announced its participation in the 7th Annual Evercore ISI HealthCONx Conference. CEO Elisabet de los Pinos will engage in a fireside chat on December 3, 2024, at 2:35 p.m. ET. The clinical-stage biotechnology company, which focuses on developing precision therapies for solid tumors, will make the presentation available via live webcast on their investor relations website. A replay will be accessible for 90 days after the event.
Aura Biosciences (NASDAQ: AURA) reported Q3 2024 financial results and clinical progress. The company presented positive Phase 2 end-of-study data for bel-sar in early-stage choroidal melanoma, showing 80% tumor control rate and 90% visual acuity preservation. In the Phase 1 trial for bladder cancer, 4 out of 5 patients with low-grade disease achieved complete response. The company's cash position of $174.4 million is expected to fund operations into 2H 2026. Q3 net loss increased to $21.0 million from $18.5 million year-over-year, with R&D expenses at $17.0 million and G&A expenses at $6.2 million.
Aura Biosciences (NASDAQ: AURA) announced positive early data from an ongoing Phase 1 clinical trial of bel-sar (AU-011) in patients with Non-Muscle-Invasive Bladder Cancer (NMIBC). The trial includes 13 patients, evaluating safety and feasibility of local administration of bel-sar alone and with light activation. Key findings include:
- 4 out of 5 patients with low grade disease demonstrated a clinical complete response
- 2 out of 3 patients with high grade disease showed visual tumor shrinkage
- Favorable safety profile with only Grade 1 drug-related adverse events reported in less than 10% of patients
- Evidence of bladder urothelial field effect in non-target tumors
Bel-sar, a virus-like drug conjugate, shows potential as a transformative cancer treatment with rapid tumor response and immune oncology effect. Aura is preparing for a Phase 2 trial to further evaluate bel-sar's clinical activity and durability of response.
Aura Biosciences (NASDAQ: AURA) reported positive Phase 2 end of study results for bel-sar (AU-011) in treating early-stage choroidal melanoma (CM). The study showed an 80% tumor control rate and 90% visual acuity preservation among Phase 3-eligible patients. Bel-sar demonstrated a highly favorable safety profile with no treatment-related serious adverse events. The drug achieved complete cessation of growth in responders, with a post-treatment average growth rate of 0.011 mm/yr compared to 0.351 mm/yr prior to study entry (p<0.0001). Notably, 80% of patients were at high risk for vision loss due to tumor proximity to critical eye structures. These results are significant given the poor prognosis associated with CM and the lack of approved vision-preserving therapies. Aura is currently enrolling patients in the global Phase 3 CoMpass trial for bel-sar.
Aura Biosciences (NASDAQ: AURA) announced a virtual urologic oncology investor event on October 17, 2024, to present early Non-Muscle Invasive Bladder Cancer (NMIBC) data from its ongoing Phase 1 trial. The event will feature key opinion leaders discussing the trial data, unmet medical needs, and current NMIBC treatment landscape. The Phase 1 trial is evaluating bel-sar (AU-011), a novel virus-like drug conjugate, as a monotherapy prior to standard care.
Additionally, Aura announced that Dr. Sabine Brookman-May will join as Senior Vice President, Clinical Development Urologic Oncology in October 2024. Dr. Brookman-May brings over 20 years of experience in urology and will lead Aura's urologic oncology therapeutic area, focusing on developing bel-sar for bladder cancer treatment.
Aura Biosciences (NASDAQ: AURA), a clinical-stage biotech company developing precision therapies for solid tumors, has announced its participation in two upcoming investor conferences. The company will attend the Morgan Stanley 22nd Annual Global Healthcare Conference on September 4, 2024, where senior management will engage in one-on-one investor meetings. Additionally, Aura will participate in the H.C. Wainwright 26th Annual Global Investment Conference on September 9, 2024, featuring both investor meetings and a virtual presentation by CEO Elisabet de los Pinos, PhD.
The virtual presentation at the H.C. Wainwright conference will be available at 7:00 am ET on September 9, 2024, accessible via the company's website and the conference platform. This presentation will remain archived on Aura's website for 90 days following the event, providing extended access for interested parties.
Aura Biosciences (NASDAQ: AURA) announced the upcoming presentation of Phase 2 end of study data for bel-sar, a treatment for early-stage choroidal melanoma, at The Retina Society Annual Meeting in Lisbon, Portugal. The presentation, titled 'Final Results of a Phase 2 Trial of Suprachoroidal Administration of Belzupacap Sarotalocan (bel-sar, AU-011) for Choroidal Melanoma', will be given by Dr. Ivana Kim on September 12, 2024.
Additionally, Aura will host a virtual ocular oncology investor event on the same day, featuring Dr. Kim and Dr. Prithvi Mruthyunjaya, to discuss the Phase 2 data. The event will include a live Q&A session and will be available for replay on Aura's website for 90 days.
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