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Healthcare

Avidity Biosciences Inc.

10/14/2025 | Press release | Distributed by Public on 10/14/2025 07:30

Material Event (Form 8-K)

Item 8.01.

Other Events.

On October 13, 2025, Avidity Biosciences, Inc. ("Avidity") announced that based on a pre-Biologics License Application ("BLA") meeting with the U.S. Food and Drug Administration ("FDA") regarding Avidity's planned BLA submission for del-zota, Avidity has updated its expected timing for submission of the BLA to the first quarter of 2026 from its previous guidance of year end 2025 in order to provide the FDA with additional non-clinical data to support the chemistry, manufacturing, and controls ("CMC") package.

Avidity Biosciences Inc. published this content on October 14, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on October 14, 2025 at 13:30 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]