Avidity Biosciences, Inc. reported a net loss of $684.6 million for the year ended December 31, 2025, a significant increase from the $322.3 million loss in 2024. The company's revenue increased to $18.8 million from $10.9 million in the previous year, primarily driven by a $10.0 million milestone payment under the Eli Lilly and Company agreement. As of December 31, 2025, Avidity held cash, cash equivalents, and marketable securities totaling $1.7 billion.

The company's research and development expenses surged to $559.2 million in 2025, compared to $303.6 million in 2024. This increase was attributed to the progression of clinical trials and preclinical studies for its three lead programs, del-zota, del-desiran, and del-brax, as well as higher unallocated manufacturing costs related to monoclonal antibodies. General and administrative expenses also rose substantially to $205.5 million from $86.2 million, due to increased personnel costs and professional fees, including $35.9 million in transaction-related costs associated with the pending merger with Novartis AG.

A key strategic development for Avidity in 2025 was the October 25th agreement to be acquired by Novartis, contingent upon the spin-off of its early-stage precision cardiology programs into a new entity, Atrium Therapeutics, Inc. (SpinCo). The transaction is expected to close in the first half of 2026, subject to customary closing conditions, including regulatory approvals and the distribution of SpinCo shares to Avidity stockholders. The company also announced a Managed Access Program (MAP) for del-zota in the United States, providing access to eligible patients with Duchenne muscular dystrophy amenable to exon 44 skipping (DMD44).

Operationally, Avidity achieved several milestones across its clinical programs. The company completed a positive pre-BLA meeting with the FDA for del-zota, with a BLA submission planned for 2026. The Phase 3 HARBOR trial for del-desiran was fully enrolled with 159 participants, and a protocol amendment was submitted to the FDA to extend the data cutoff date to 54 weeks. For del-brax, the company announced FDA alignment on accelerated and full approval pathways and initiated the global confirmatory Phase 3 FORTITUDE-3 study. As of February 13, 2026, Avidity had 511 full-time employees, including 111 with Ph.D. or M.D. degrees.

Looking ahead, Avidity anticipates topline data from the FORTITUDE biomarker cohort for del-brax in the second quarter of 2026, and 54-week topline data from the Phase 3 HARBOR study for del-desiran in the second half of 2026. The company's BLA submission for del-zota is planned for 2026, and the Phase 3 FORTITUDE-3 readout and global regulatory submissions for del-brax are expected in 2028. The company's strategy remains focused on its AOC platform, advancing its pipeline, and building an agile and diverse company.

About Avidity Biosciences, Inc.

Avidity Biosciences, Inc. is a biopharmaceutical company developing Antibody Oligonucleotide Conjugates (AOCs), a novel RNA therapeutic platform combining monoclonal antibodies with oligonucleotides to target disease-causing RNA. Focused on rare neuromuscular diseases like myotonic dystrophy, facioscapulohumeral muscular dystrophy, and Duchenne muscular dystrophy, Avidity aims to deliver precise, scalable treatments addressing underlying genetic causes with improved tissue targeting and dosing convenience.

This description was generated via AI from an annual report. Updated 9 months ago.

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