Aura Biosciences, Inc. - AURA STOCK NEWS

Aura Biosciences, Inc. (NASDAQ: AURA) has received Fast Track designation from the FDA for its drug candidate belzupacap sarotalocan (AU-011), aimed at treating Non-Muscle Invasive Bladder Cancer (NMIBC). This designation facilitates a more efficient development process, enabling frequent communication with the FDA and potential for Priority Review. The planned Phase 1 clinical trial will assess safety and treatment efficacy, with data expected in 2023. Aura also has Fast Track and Orphan Drug designations for AU-011 in choroidal melanoma.

Aura Biosciences Inc. (NASDAQ: AURA) announced results from a retrospective study comparing visual acuity outcomes in early-stage choroidal melanoma patients treated with belzupacap sarotalocan against those receiving plaque radiotherapy. The study indicated significant vision preservation (p = 0.0094) for belzupacap sarotalocan, highlighting the urgent need for effective therapies in this patient population. The Chief Medical Officer emphasized the potential of belzupacap sarotalocan to shift treatment paradigms, with ongoing Phase 2 trials exploring further efficacy.

Aura Biosciences (NASDAQ: AURA) presented data on its virus-like drug conjugate (VDC), belzupacap sarotalocan (AU-011), for treating early-stage choroidal melanoma at the ISOO 2022 Bi-Annual Meeting in the Netherlands. Key findings include updated safety results from a Phase 2 trial using suprachoroidal administration and final efficacy data from a Phase 1b/2 trial with intravitreal administration. Aura plans to finalize the administration route and begin its pivotal program by year's end, underscoring its commitment to vision-preserving therapies.

Aura Biosciences Inc. (AURA) announced the publication of preclinical data for AU-011, its first Virus-Like Drug Conjugate (VDC) candidate, at the 2022 ASCO Annual Meeting. The combination of AU-011 with immune checkpoint inhibitors demonstrated effectiveness against primary tumors and metastases in preclinical models, suggesting potential for treating life-threatening cancers such as choroidal melanoma and non-muscle invasive bladder cancer. The research highlights collaboration with Leiden University Medical Center, enhancing the clinical prospects of AU-011.

Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology firm, has announced participation in two upcoming investor conferences. The first is Cowen's Virtual 3rd Annual Oncology Innovation Summit on June 2, 2022, featuring a fireside chat at 9:00 a.m. ET. The second is the Jefferies Global Healthcare Conference on June 8, 2022, with a presentation at 1:30 p.m. ET. Live webcasts for these events will be available on the company's website, with replays archived for 90 days. Aura is developing virus-like drug conjugates for various oncology indications, currently focusing on AU-011 for ocular cancers.

Aura Biosciences Inc. (NASDAQ: AURA) announced significant clinical milestones for AU-011 in oncology, including the initiation of pivotal trials in choroidal melanoma and phase 1 trials for non-muscle invasive bladder cancer. The company reported Q1 2022 financials, showing a net loss of $12.8 million, up from $5.9 million in Q1 2021. Operating expenses rose due to increased R&D and administrative costs. As of March 31, 2022, Aura had $133.3 million in cash, sufficient to fund operations into 2024. The company maintains a focus on developing VDC therapies for various cancer indications.

Aura Biosciences (NASDAQ: AURA) presented new preclinical data for its VDC product candidate, AU-011, at the ARVO Annual Meeting in Denver. The data indicates AU-011's targeted cytotoxicity against tumor cells commonly metastasizing to the choroid, including breast, renal, and colon cancers. CEO Elisabet de los Pinos emphasized the potential of AU-011 as a treatment for ocular cancers. The company plans to submit an IND for choroidal metastasis in the latter half of this year, further advancing its ocular oncology initiatives.

Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology firm, announces that CEO Elisabet de los Pinos will present at the 2022 Bank of America Healthcare Conference in Las Vegas on May 10, 2022, at 4:55 p.m. PT. The presentation will be available via a live webcast on Aura's website, with a replay accessible for 90 days thereafter.

Aura specializes in virus-like drug conjugate therapies for oncology, with its lead candidate, AU-011, targeting ocular cancers, specifically choroidal melanoma. The company aims to broaden the use of AU-011 in multiple cancers, including bladder cancer.

Aura Biosciences reported its financial results for the fourth quarter and year ending December 31, 2021, highlighting advancements in its AU-011 program. The company is set to initiate pivotal trials for early-stage choroidal melanoma and a Phase 1 trial for non-muscle invasive bladder cancer in the second half of 2022. Aura received Orphan Drug Designation from the European Commission for AU-011, enhancing its market position. The cash position of $149.1 million is expected to fund operations into 2024, despite increased R&D expenses resulting in a net loss of $35.3 million for the year.