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Aura Biosciences Receives FDA Agreement Under Special Protocol Assessment (SPA) for CoMpass Phase 3 Clinical Trial of Belzupacap Sarotalocan (Bel-sar) in Early-stage Choroidal Melanoma

Aura Biosciences Receives FDA Agreement Under Special Protocol Assessment (SPA) for CoMpass Phase 3 Clinical Trial of Belzupacap Sarotalocan (Bel-sar) in Early-stage Choroidal Melanoma

BOSTON--(BUSINESS WIRE)--Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced it has received agreement from the U.S. Food and Drug Administration (FDA) under an SPA for the design and planned analysis of CoMpass, the Company’s global Phase 3 clinical trial of bel-sar for the first-line treatment of adult patients with early-stage choroidal melanoma (CM). The Company also announced the presentation of positive Phase 2 safety and efficacy data of bel-sar with 90% of patients at twelve months of follow-up evaluating two key clinical endpoints: tumor control and visual acuity preservation using suprachoroidal (SC) route of administration for the first-line treatment of adult patients with early-stage CM. The results were presented at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting in San Francisco, California.

Aura / Uncategorized - 11/07/2023

Aura Biosciences Receives FDA Fast Track Designation for Belzupacap Sarotalocan (AU-011) for the Treatment of Non-Muscle Invasive Bladder Cancer

CAMBRIDGE, MA -- June 30, 2022 -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for belzupacap sarotalocan (AU-011), Aura’s first VDC product candidate, for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).

Aura - 06/30/2022

Aura Biosciences Announces Pricing of Initial Public Offering

CAMBRIDGE, Mass. -- Aura Biosciences, Inc. (“Aura”), a clinical-stage oncology company developing a novel class of virus-like drug conjugate therapies for multiple oncology indications, today announced the pricing of its initial public offering of 5,400,000 shares of common stock at a public offering price of $14.00 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Aura, are expected to be $75.6 million. All of the shares are being offered by Aura. In addition, Aura has granted the underwriters a 30-day option to purchase up to an additional 810,000 shares of common stock at the initial public offering price less underwriting discounts and commissions.

Aura - 10/29/2021
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