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Avidity Biosciences, Inc. (Nasdaq: RNA) generates news flow centered on its development of Antibody Oligonucleotide Conjugates (AOCs™), a class of RNA therapeutics designed to combine monoclonal antibody specificity with oligonucleotide precision. Company announcements frequently highlight progress across its late-stage neuromuscular pipeline, including programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD).
News items for RNA often cover clinical trial milestones, such as topline and long-term data from the EXPLORE44® and EXPLORE44-OLE™ studies of delpacibart zotadirsen (del-zota) in DMD44, enrollment and data plans for the HARBOR™ Phase 3 trial of del-desiran in DM1, and development updates for del-brax and the FORTITUDE™ and FORTITUDE-3™ programs in FSHD. Regulatory developments are another key theme, including the FDA’s Breakthrough Therapy designation for del-zota and disclosures about planned Biologics License Application (BLA) submissions.
Investors following Avidity’s news can also expect coverage of financing activities, such as public offerings of common stock, collaboration milestones with partners like Eli Lilly and Company and Bristol Myers Squibb, and updates on the company’s cash position as reported in periodic financial results. Corporate and strategic news includes participation in scientific and investor conferences, as well as detailed announcements about the definitive merger agreement with Novartis AG and the planned separation of early-stage precision cardiology programs into a new company referred to as SpinCo.
In addition, Avidity regularly reports on its engagement with patient and advocacy communities, particularly during National Muscular Dystrophy Awareness Month and events focused on Duchenne muscular dystrophy, myotonic dystrophy, FSHD and rare diseases. For readers tracking RNA, this news page provides a centralized view of clinical, regulatory, financial and transaction-related developments that shape the company’s trajectory.
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.
Cartography Biosciences has appointed Troy E. Wilson, Ph.D., J.D. as an independent director to its Board of Directors. Wilson, a 25-year biopharma industry veteran, is currently President, CEO, and co-founder of Kura Oncology (NASDAQ: KURA). He brings extensive experience in founding and leading biotech companies, including Avidity Biosciences, Araxes Pharma, and Wellspring Biosciences. Cartography, an oncology company developing antibody therapeutics, aims to leverage Wilson's expertise as it advances its pipeline of novel programs targeting tumors more precisely than existing treatments.
Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company developing Antibody Oligonucleotide Conjugates (AOCs™), has granted equity awards to 34 new non-executive employees under its 2022 Employment Inducement Incentive Award Plan. The grants include:
- 421,600 non-qualified stock options to purchase common stock
- 210,800 restricted stock units (RSUs)
These awards are intended as employment inducements in compliance with Nasdaq Listing Rule 5635(c)(4). The stock options have an exercise price of $50.45 per share, equal to the closing price of Avidity's common stock on October 18, 2024. The options will vest over four years, with 25% vesting after one year and the remainder vesting monthly over 36 months. RSUs will vest in four equal annual installments. All awards are subject to continued employment with Avidity.
Avidity Biosciences (Nasdaq: RNA) announced that the FDA has removed the partial clinical hold on delpacibart etedesiran (del-desiran/AOC 1001), an investigational treatment for myotonic dystrophy type 1 (DM1). Del-desiran is currently being evaluated in the Phase 3 HARBOR™ trial for DM1, a progressive and often fatal neuromuscular disease with no approved therapies.
Del-desiran is designed to address the root cause of DM1 and has received Breakthrough Therapy, Orphan Drug, and Fast Track designations from the FDA, as well as Orphan designation from the EMA. Avidity Biosciences is developing a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™).