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 Biosciences (RNA) has granted equity awards to one new non-executive employee under its 2022 Employment Inducement Incentive Award Plan. The grants include a non-qualified stock option to purchase 10,500 shares of common stock at $28.92 per share and 5,250 restricted stock units (RSUs).
The stock options will vest over four years, with 25% vesting after one year from December 20, 2024, and the remaining vesting monthly over 36 months. The RSUs will vest in four equal annual installments. These awards were granted as employment inducements in accordance with Nasdaq Listing Rule 5635(c)(4) and are subject to continued employment with Avidity.
Avidity Biosciences (Nasdaq: RNA) has announced inducement grants to its new Chief Technical Officer, Charles Calderaro III. The grants include a non-qualified stock option to purchase 80,000 shares of common stock and 40,000 restricted stock units (RSUs) under the company's 2022 Employment Inducement Incentive Award Plan.
The stock option has an exercise price of $31.42 per share, matching Avidity's closing price on Nasdaq on January 6, 2025. The stock options will vest over four years, with 25% vesting after one year and the remainder vesting monthly over 36 months. The RSUs will vest in four equal annual installments. Both grants are subject to Mr. Calderaro's continued employment with Avidity.
Avidity Biosciences (RNA) announced significant plans for 2025, including its first Biologics License Application (BLA) submission for del-zota in treating Duchenne muscular dystrophy. The company confirmed an accelerated approval path and plans for multiple product launches in DMD44, DM1, and FSHD rare muscle diseases.
The company is expanding its leadership team with Eric Mosbrooker as Chief Commercial Officer, Charles Calderaro III as Chief Technical Officer, and Kat Lange as Chief Business Officer to support global commercialization efforts.
Key 2025 milestones include: BLA submission for del-zota by year-end, completion of enrollment in del-desiran HARBOR Phase 3 trial and del-brax biomarker cohort by mid-2025, and initiation of a global pivotal trial for del-brax. Marketing applications for del-desiran are planned for 2026 in the U.S. and European Union.
Avidity Biosciences (RNA) has granted equity awards to 37 new non-executive employees under its 2022 Employment Inducement Incentive Award Plan. The grants include 720,400 non-qualified stock options with an exercise price of $31.82 per share and 276,200 restricted stock units (RSUs).
The stock options will vest over four years, with 25% vesting after one year and the remainder vesting monthly over 36 months. The RSUs will vest in four equal annual installments. These awards were granted as employment inducements in accordance with Nasdaq Listing Rule 5635(c)(4).
Avidity Biosciences (Nasdaq: RNA), a developer of Antibody Oligonucleotide Conjugates (AOCs™), has announced its participation in the upcoming 7th Annual Evercore ISI HealthCONx Conference. The presentation is scheduled for December 3 at 9:30 a.m. PT / 12:30 p.m. ET. Interested parties can access a live webcast and replay of the event through the company's investor relations website under the 'Events and Presentations' section.
Avidity Biosciences (RNA) has granted equity awards to 12 new non-executive employees under its 2022 Employment Inducement Incentive Award Plan. The grants include non-qualified stock options to purchase 117,000 shares and 58,500 restricted stock units (RSUs). The stock options have an exercise price of $43.65 per share, equal to the closing price on November 20, 2024. The options will vest over four years, with 25% vesting after one year and the remainder monthly over 36 months. RSUs will vest in four equal annual installments, subject to continued employment.
Avidity Biosciences (Nasdaq: RNA) has expanded into precision cardiology with two new development candidates: AOC 1086 for PLN Cardiomyopathy and AOC 1072 for PRKAG2 Syndrome. Preclinical studies showed approximately 80% reduction in cardiac PLN mRNA and PRKAG2 mRNA through direct siRNA delivery to the heart. The company also revealed next-generation technology innovations demonstrating up to 30-fold increase in siRNA delivery to skeletal muscle and three-month sustained target inhibition in preclinical studies. Both candidates were well-tolerated with no effect on cardiac safety parameters. AOC 1072 data will be presented at the AHA Scientific Sessions 2024.
Avidity Biosciences reported its Q3 2024 financial results and recent highlights. The company is advancing three key clinical trials: del-zota for DMD44, del-brax for FSHD, and del-desiran for DM1. The Phase 1/2 EXPLORE44 trial for del-zota showed a 25% increase in dystrophin production and reduced creatine kinase levels. Enrollment for the Phase 3 HARBOR trial for del-desiran is on track, with the FDA lifting a partial clinical hold. Del-brax's biomarker cohort in the FORTITUDE study shows promising results. Avidity raised $345.1 million in a public offering and reported $1.6 billion in cash and marketable securities. Collaboration revenue was $2.3 million for Q3 2024. R&D expenses increased to $77.2 million, and G&A expenses rose to $23.3 million due to expanded operations. A webcast event on November 12, 2024, will showcase precision cardiology candidates and next-gen technology innovations.
Avidity Biosciences (Nasdaq: RNA) has announced an upcoming investor and analyst event (Volume 11) scheduled for November 12, 2024, at 8:00 a.m. ET. The company will unveil new development candidates from its precision cardiology portfolio and showcase next-generation technology innovations.
Additionally, Avidity will present a poster on their lead precision cardiology candidate at the American Heart Association (AHA) Scientific Sessions 2024 on November 16, 2024, at 11:40 a.m. CT in Chicago. The presentation will focus on a novel precision cardiology treatment for PRKAG2 Cardiomyopathy, a subset of patients with Wolff-Parkinson-White Syndrome.
Avidity Biosciences has initiated a biomarker cohort in the Phase 1/2 FORTITUDE™ trial of delpacibart braxlosiran (del-brax) for facioscapulohumeral muscular dystrophy (FSHD). The company is pursuing an accelerated approval path, with enrollment expected to complete in 1H 2025. Initial data showed del-brax 2 mg/kg administered every six weeks achieved >50% reductions in DUX4 regulated genes, ≥25% decreases in novel circulating biomarker and creatine kinase, with trends of functional improvement. The biomarker cohort will assess del-brax's impact on patients aged 16-70, focusing on changes in DUX4 regulated gene expression and biomarkers. Del-brax is the first potential therapy targeting DUX4, the disease-causing gene in FSHD.
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