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. (NASDAQ: AURA) is a clinical-stage biotechnology company headquartered in Boston, Massachusetts, developing precision therapies for solid tumors that aim to preserve organ function. News about AURA stock frequently centers on clinical trial milestones, regulatory designations, financing activities, and participation in healthcare and investor conferences.
A key theme in Aura’s news flow is progress with its lead candidate, bel-sar (AU-011). The company regularly reports updates on the global Phase 3 CoMpass trial in early or early-stage choroidal melanoma, which it describes as the first registration-enabling study in this indication. Press releases also cover developments in additional ocular oncology programs, including metastases to the choroid and cancers of the ocular surface, and in non-muscle invasive bladder cancer, where Aura has shared Phase 1 data and details of an ongoing Phase 1b/2 trial.
Investors following AURA news can expect recurring coverage of regulatory interactions, such as Orphan Drug and Fast Track designations for bel-sar, as well as financial updates through quarterly and annual results furnished via Form 8-K. Aura’s announcements also include public offering details, cash runway commentary, and information about patent applications for new formulations of bel-sar in urologic oncology.
In addition, Aura frequently announces participation in healthcare and life sciences conferences, fireside chats, and investor events, where senior management discusses the company’s pipeline and strategy. For anyone tracking AURA, this news page provides a centralized view of Aura Biosciences’ clinical progress, corporate developments, and capital markets activity over time.
Aura Biosciences (NASDAQ: AURA) has appointed Teresa Bitetti to its Board of Directors, effective March 31, 2025. Bitetti currently serves as President of the Global Oncology Business Unit at Takeda, where she manages a multi-billion-dollar oncology portfolio across major markets including the US, Europe, and Japan.
As a seasoned executive, Bitetti brings extensive operational and commercial experience from her previous roles, including Senior Vice President positions at Bristol Myers Squibb (BMS) where she led worldwide oncology commercialization and headed U.S. Oncology operations. Her expertise spans multiple therapeutic areas including infectious diseases and neuroscience.
The appointment aligns with Aura's focus on developing precision therapies for solid tumors while preserving organ function, particularly in ocular and urologic oncology.
Aura Biosciences (NASDAQ: AURA) reported its Q4 and full year 2024 financial results, highlighting significant progress in its clinical pipeline. The company's lead candidate bel-sar showed positive Phase 1 trial data in Non-Muscle Invasive Bladder Cancer (NMIBC) at the European Association of Urology Congress, demonstrating clinical complete responses and robust cell-mediated immunity.
The Phase 3 CoMpass trial for early-stage choroidal melanoma is actively enrolling globally, with over 175 patients registered in pre-screening since June 2024. The company has also initiated a Phase 2 trial for metastases to the choroid, with initial data expected in 2025.
Financial highlights include:
- Cash position of $151.1 million, expected to fund operations into 2H 2026
- R&D expenses increased to $73.3 million for full year 2024
- Net loss of $86.9 million for full year 2024
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.