AOC 1044

Avidity Biosciences Submits Biologics License Application to FDA for del-zota

Today, Avidity Biosciences announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of delpacibart zotadirsen (del-zota) for individuals living with Duchenne who are amenable…

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September 10, 2025

Avidity Biosciences Announces Positive New Data from EXPLORE44® and EXPLORE44-OLE™ Phase 1/2 Studies

Today, Avidity Biosciences announced new data from its EXPLORE44® and EXPLORE44-OLE™ Phase 1/2 studies of del-zota in people living with Duchenne muscular dystrophy amenable to exon 44 skipping. Del-zota is designed to deliver phosphorodiamidate morpholino…

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FDA Grants Breakthrough Therapy Designation to Avidity’s del-zota

Avidity Biosciences, Inc. today shared that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to del-zota (AOC 1044) for the treatment of Duchenne in individuals amenable to exon 44 skipping. Del-zota…

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Watch: Avidity Biosciences – Topline Data from EXPLORE44® Clinical Trial (Webinar Recording)

Avidity Biosciences recently joined PPMD for a community webinar to share topline data from their EXPLORE44® clinical trial, which is assessing the safety and efficacy of the investigational therapy delpacibart zotadirsen (formerly AOC 1044, abbreviated…

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January 9, 2025

Avidity Biosciences Announces Plans to File Biologics License Application for Delpacibart Zotadirsen (AOC 1044)

Avidity Biosciences, Inc. has announced its plans for filing a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for delpacibart zotadirsen (del-zota) for treatment of individuals living with Duchenne muscular dystrophy…

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Avidity Biosciences Announces Positive Data From Phase 1/2 EXPLORE44™ Trial of AOC 1044 in Individuals Amenable to Exon 44 Skipping

Avidity Biosciences, Inc. today announced positive data from the company’s Phase 1/2 EXPLORE44™ clinical trial of AOC 1044, an exon skipping therapy targeting those amenable to exon 44 skipping. Avidity also announced the approved international…

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February 13, 2023

Watch: Avidity Biosciences – EXPLORE44 Clinical Trial Investigating AOC 1044 – Webinar Recording

WATCH: Avidity Biosciences – EXPLORE44 Clinical Trial Investigating AOC 1044 in Individuals Amenable to Exon 44 Skipping Avidity Biosciences recently joined PPMD for a community webinar on February 8, 2023 to discuss the EXPLORE44™ clinical…

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September 27, 2022

Avidity Biosciences Announces FDA Clearance of IND Application for AOC 1044

PPMD is excited to share that Avidity Biosciences has announced that they have received clearance from the FDA on their Investigational New Drug (IND) application for AOC 1044, an exon skipping therapy targeting those amenable to exon…

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