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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 Biosciences announced positive results from its Phase 1/2 FORTITUDE trial for AOC 1020 (delpacibart braxlosiran), targeting facioscapulohumeral muscular dystrophy (FSHD). The therapy showed over 50% reduction in DUX4 regulated genes and improvements in muscle strength and function after four months at a 2 mg/kg dose. All adverse events were mild or moderate. The company plans to accelerate the registrational cohorts of the trial. Delpacibart braxlosiran directly targets the root cause of FSHD, a rare genetic disorder with no approved treatments. The data will be presented at the FSHD Society International Research Congress. The company also hosted a virtual investor event to discuss these findings.
Avidity Biosciences (Nasdaq: RNA) will present preliminary data from the Phase 1/2 FORTITUDE™ trial of AOC 1020 targeting facioscapulohumeral muscular dystrophy (FSHD) at the 31st Annual FSHD Society International Research Congress in Denver, CO. Dr. Jeffrey M. Statland, a trial investigator, will join Avidity's management for the presentations. The data will be discussed in an oral presentation on June 14, 2024, and a poster presentation on June 13, 2024, focusing on increasing diversity in clinical trial participation. A live webcast event to discuss the trial's preliminary data will be held on June 12, 2024, at 8:00 a.m. ET, with a replay available afterward on the company's website.
Avidity Biosciences, a biopharmaceutical company specializing in RNA therapeutics, announced inducement grants under Nasdaq Listing Rule 5635(c)(4) on May 20, 2024.
The Human Capital Management Committee granted stock option awards for 150,500 shares and 33,250 restricted stock units (RSUs) to seven new non-executive employees.
The stock options, priced at $29.24 per share, will vest over four years with 25% vesting after one year and the remainder vesting monthly.
RSUs will vest in four equal annual installments, contingent on continued employment.
These awards are part of the 2022 Employment Inducement Incentive Award Plan, targeting new employees as a material inducement for employment, in accordance with Nasdaq Listing Rule 5635(c)(4).
Avidity Biosciences (Nasdaq: RNA) announced the appointment of Simona Skerjanec to its board of directors. Ms. Skerjanec brings nearly three decades of pharmaceutical experience, specializing in developing and launching therapies, and corporate strategy. Her roles at Roche, The Medicines Company, Eli Lilly, Pfizer, and Johnson & Johnson highlight her expertise in neurology, cardiology, and rare diseases. Avidity CEO Sarah Boyce emphasized the importance of Ms. Skerjanec’s experience in advancing Avidity's RNA therapeutic programs, including neuromuscular and precision cardiology. Ms. Skerjanec expressed her excitement to contribute to Avidity's mission of revolutionizing RNA therapeutics.
Avidity Biosciences reported their first-quarter 2024 financial results and recent highlights, including the initiation of a global Phase 3 trial for del-desiran in DM1, positive long-term del-desiran data showing disease progression reversal in DM1 patients, and a cash position of $915 million. The company also received Breakthrough Therapy designation from the FDA for del-desiran and announced positive data from their FSHD and DMD44 trials. They raised $400 million through an equity raise and plan to share more data from ongoing trials later in the year.
Avidity Biosciences, Inc. (Nasdaq: RNA) will participate in the BofA Securities 2024 Health Care Conference on May 15. The company focuses on RNA therapeutics known as Antibody Oligonucleotide Conjugates (AOCs™). The event will be live-streamed and archived on the company's website.
Avidity Biosciences, Inc. (Nasdaq: RNA) has received FDA Breakthrough Therapy designation for delpacibart etedesiran (AOC 1001) for treating Myotonic Dystrophy Type 1. The company is starting a global Phase 3 HARBOR study for del-desiran this quarter. Data from MARINA-OLE showed reversal of disease progression in DM1 patients. Del-desiran aims to address the root cause of DM1, a fatal neuromuscular disease with no approved treatments.
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