Welcome to our dedicated page for Avidity Biosciences news (Ticker: RNA), a resource for investors and traders seeking the latest updates and insights on Avidity Biosciences stock.
Avidity Biosciences, Inc. (Nasdaq: RNA) is a pioneering biopharmaceutical company dedicated to revolutionizing RNA therapeutics with its proprietary Antibody Oligonucleotide Conjugates (AOCs™). Their innovative approach merges the specificity of monoclonal antibodies with the precision of oligonucleotide therapies, enabling targeted treatment of diseases that were previously unreachable with existing RNA therapies. They are at the forefront of developing therapies for serious genetic conditions, predominantly focusing on rare muscle diseases.
Avidity's leading clinical programs include:
- AOC 1001 (Del-desiran): Targeting Myotonic Dystrophy Type 1 (DM1), a disease with no approved therapies. Del-desiran has shown promising long-term data from the MARINA-OLE™ trial, demonstrating reversal of disease progression in patients. The global Phase 3 HARBOR™ trial is set to begin, with video hand opening time (vHOT) as the primary endpoint.
- AOC 1044: Aimed at Duchenne Muscular Dystrophy (DMD) with mutations amenable to exon 44 skipping. Recently, it achieved Rare Pediatric Disease and Orphan Drug designations from the FDA and EMA. Positive preliminary data has been reported from the Phase 1/2 EXPLORE44™ clinical trial.
- AOC 1020: Focused on Facioscapulohumeral Muscular Dystrophy (FSHD). Clinical data from the Phase 1/2 FORTITUDE™ trial is expected soon.
Avidity is also advancing its pipeline to include cardiology and immunology programs, aiming to target a broader range of diseases. The company has garnered support and collaborations with top-tier investors and strategic partners, enhancing its capability to deliver groundbreaking treatments.
With headquarters in San Diego, CA, Avidity Biosciences is committed to transforming lives through innovative RNA therapeutics. For more information, visit www.aviditybiosciences.com.
Avidity announced the initiation of the Phase 1/2 FORTITUDE clinical trial for AOC 1020, targeting facioscapulohumeral muscular dystrophy (FSHD), affecting 16,000-38,000 individuals in the U.S. AOC 1020 aims to address the underlying cause of FSHD by targeting the DUX4 gene. This is Avidity's second siRNA AOC to enter clinical development, adding to their portfolio of three rare disease programs, including myotonic dystrophy type 1 and Duchenne muscular dystrophy. The trial will evaluate safety and tolerability, with a preliminary safety assessment expected in Q4 2022.
Avidity Biosciences (Nasdaq: RNA) announced a partial clinical hold by the FDA on new participant enrollment in the Phase 1/2 MARINA™ trial of AOC 1001 for myotonic dystrophy type 1 (DM1) due to a serious adverse event in a participant. Around 40 participants continue in the ongoing MARINA and MARINA-OLE™ trials, but no new enrollments are permitted until the issue is resolved. Avidity received IND clearance for AOC 1020 for facioscapulohumeral muscular dystrophy (FSHD) and AOC 1044 for Duchenne muscular dystrophy (DMD), advancing these programs into clinical trials.
Avidity Biosciences (Nasdaq: RNA) is poised to advance three muscular dystrophy programs into clinical trials by the end of 2022. In conjunction with National Muscular Dystrophy Awareness Month, the company will engage with patient communities and partake in several events, including the MDF Annual Conference and the FSHD Society's Walk and Roll. The lead program, AOC 1001, targets myotonic dystrophy type 1. Avidity's innovative Antibody Oligonucleotide Conjugates (AOCs™) aim to address previously untreatable rare diseases.
Avidity Biosciences (Nasdaq: RNA) announced its participation in two key investor conferences: the 2022 Wells Fargo Healthcare Conference on September 7 at 1:20 pm ET and the Chardan 6th Annual Genetic Medicines Conference on October 4 at 11:30 am ET. Interested parties can access live webcasts and replays via Avidity's 'Events and Presentations' page. The company focuses on innovative RNA therapeutics, specifically Antibody Oligonucleotide Conjugates (AOCs™), with three programs expected in clinical development by the end of 2022, including AOC 1001 for myotonic dystrophy.
Avidity Biosciences (RNA) reported Q2 2022 financial results, announcing progress on its three AOC programs targeting rare diseases: myotonic dystrophy type 1 (DM1), facioscapulohumeral muscular dystrophy (FSHD), and Duchenne muscular dystrophy (DMD). The company is on track to have these programs in the clinic by year-end. Avidity holds over $400 million in cash, expected to fund operations through 2024. R&D expenses surged to $39.8 million, reflecting advancements in their pipeline, while collaboration revenue saw a decline to $2.2 million, attributed to timing issues.
Avidity Biosciences (Nasdaq: RNA) has initiated the MARINA-OLE study, allowing patients enrolled in the Phase 1/2 MARINA trial to receive ongoing treatment with AOC 1001 for myotonic dystrophy type 1 (DM1). This follows the FDA's Fast Track and Orphan Designations for AOC 1001. The MARINA trial, which aims to evaluate safety and tolerability, is expected to report preliminary data by Q4 2022. DM1, a progressive and potentially fatal neuromuscular disease, currently lacks disease-modifying treatments. AOC 1001 targets DMPK mRNA, addressing the root cause of DM1.
Avidity Biosciences (Nasdaq: RNA) announced at the FSHD IRC in Orlando, Florida, preclinical data demonstrating that AOC 1020 can prevent muscle weakness by reducing DUX4 expression, a critical factor in the progression of Facioscapulohumeral muscular dystrophy (FSHD). With approximately 16,000-38,000 patients in the U.S. lacking approved therapies, AOC 1020 is on track for clinical development by the end of 2022. The data showed robust dose-dependent downregulation of DUX4 and prevention of muscle weakness in mouse models, highlighting the potential of AOC 1020 for treating FSHD.
Avidity Biosciences (Nasdaq: RNA) announced its participation in the 29th Annual FSHD Society International Research Congress in Orlando, Florida, taking place on June 16-17, 2022. The company will present an oral presentation on AOC 1020, an Antibody Oligonucleotide Conjugate (AOC) for treating Facioscapulohumeral Muscular Dystrophy (FSHD) on June 17 at 9:50 AM ET. Additionally, a poster presentation will discuss a retrospective data analysis of inpatient admissions for FSHD patients, scheduled for June 17 from 1:00 PM to 3:00 PM ET.
Avidity Biosciences, Inc. (Nasdaq: RNA) has announced its first-quarter financial results for 2022, reporting a cash balance of $397 million. Collaboration revenue for the quarter was $1.8 million, a decline from $2.7 million in Q1 2021. R&D expenses increased to $27.7 million from $20.7 million, while G&A expenses rose to $8.6 million. The company is advancing its AOC 1001 MARINA trial and plans to initiate additional programs in the clinic by year-end.
Avidity Biosciences, Inc. (Nasdaq: RNA) has announced the expansion of Michael MacLean's role to Chief Financial and Chief Business Officer. His leadership has been crucial in guiding the company through its transition to a publicly-traded, clinical-stage biopharmaceutical firm. MacLean will oversee finance, business development, supply chain, and investor relations while advancing the company's innovative RNA therapeutic platform, Antibody Oligonucleotide Conjugates (AOCs). Avidity aims to initiate three rare disease programs in clinical trials by the end of 2022.
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