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Avidity Biosciences, Inc. - RNA STOCK NEWS

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.

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Avidity Biosciences, Inc. (Nasdaq: RNA) announced that the FDA granted Fast Track Designation to its lead program, AOC 1001, for treating myotonic dystrophy type 1 (DM1). This designation facilitates more frequent interactions with the FDA, expediting the development process for serious conditions. AOC 1001 aims to reduce DMPK mRNA levels, addressing the disease's root cause. The Phase 1/2 MARINA trial will evaluate the safety and tolerability of AOC 1001, enrolling around 44 adults. Currently, DM1 lacks therapeutic options, highlighting the significance of AOC 1001's advancement.

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Avidity Biosciences, Inc. (NASDAQ: RNA) has announced its participation in two upcoming investor conferences. The Wells Fargo Virtual Healthcare Conference will take place on September 9, 2021, featuring a fireside chat at 11:20am ET. The Chardan Virtual 5th Annual Genetic Medicines Conference is scheduled for October 5, 2021, with a panel discussion at 12noon ET and a fireside chat at 1:30pm ET. Interested parties can access live webcasts and replays on Avidity's website.

Avidity aims to revolutionize RNA therapeutics through its Antibody Oligonucleotide Conjugates (AOCs™), with promising therapies in development for diseases like myotonic dystrophy and Duchenne Muscular Dystrophy.

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Avidity Biosciences (Nasdaq: RNA) announced the appointment of Eric Mosbrooker to its board of directors, enhancing its commercial perspective as the company's pipeline matures. Mosbrooker brings extensive experience in global commercial operations, particularly in gene therapy and rare diseases. The press release also noted the departure of Roderick Wong from the board, who played a crucial role during the company’s IPO and early financing stages. Avidity's mission focuses on innovative RNA therapeutics, with lead candidate AOC 1001 moving towards clinical trials.

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Avidity Biosciences, Inc. (Nasdaq: RNA) announced that the European Commission has granted orphan designation for AOC 1001, following the FDA's earlier designation. AOC 1001 targets myotonic dystrophy type 1 (DM1), offering potential benefits for patients suffering from this debilitating condition. The company has received FDA clearance to initiate the Phase 1/2 MARINA trial in the U.S. AOC 1001 aims to reduce disease-related mRNA levels and has shown promise in preclinical studies, demonstrating a favorable safety profile.

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Avidity Biosciences (RNA) announced a partnership with the Facioscapulohumeral Muscular Dystrophy Clinical Trial Research Network to support the MOVE+ study. This initiative aims to enhance understanding of FSHD through whole-body MRI and biomarkers, focusing on accelerating clinical trial designs. Avidity is sponsoring 100 participants in the US to gather crucial data, as highlighted by CEO Sarah Boyce. This study could lead to significant advancements in patient care and therapeutic development for FSHD.

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Avidity Biosciences (Nasdaq: RNA) reported its Q2 2021 results, highlighting significant advancements in its RNA therapeutics pipeline. The FDA approved the Phase 1/2 MARINA trial for AOC 1001, targeting myotonic dystrophy type 1, marking a major milestone for the company. Financially, Avidity has $280 million in cash, a decrease from $328.1 million at the end of 2020. Collaboration revenue increased to $2.6 million in Q2 2021, up from $1.5 million in Q2 2020. R&D expenses rose significantly, totaling $22.7 million in Q2 2021, driven by the advancement of AOC candidates.

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Avidity Biosciences (RNA) announced a public offering of 8,000,000 shares at $18.00 each, aiming to raise approximately $144.0 million. The offering is expected to close on August 6, 2021. Proceeds will fund the Phase 1/2 MARINA trial for AOC 1001, advance AOC 1044 and the AOC FSHD program, and general corporate purposes. A 30-day option for underwriters to purchase an additional 1,200,000 shares is included. The offering is conducted under a shelf registration statement with the SEC.

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Avidity Biosciences, Inc. (RNA) announced a proposed public offering of $100 million in common stock, with an additional 15% option for underwriters. The offering aims to fund the Phase 1/2 MARINA trial for AOC 1001, advance AOC 1044 and the AOC FSHD program, and support working capital. The offering is subject to market conditions and uncertainties regarding completion and terms. Joint bookrunning managers include Cowen, SVB Leerink, Evercore ISI, and Wells Fargo Securities.

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Avidity Biosciences (RNA) has received FDA clearance to commence its Phase 1/2 MARINA trial for AOC 1001, aimed at treating myotonic dystrophy type 1 (DM1). This trial will enroll approximately 44 adults to assess the safety and tolerability of AOC 1001, which utilizes a monoclonal antibody conjugated with siRNA targeting DMPK mRNA, the root cause of DM1. The company has also obtained Orphan Drug Designation for AOC 1001, offering potential market exclusivity and financial incentives. Initial assessments of key biomarkers are expected in the second half of 2022.

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Avidity Biosciences (RNA) reported significant updates on its therapeutic pipeline during a virtual investor event on May 19, 2021. The event highlighted the favorable safety profile of AOC 1001, its lead program for Myotonic Dystrophy Type 1, supporting its advancement to clinical trials. Additionally, AOC 1044 was named a clinical development candidate for Duchenne Muscular Dystrophy, entering IND-enabling studies. Avidity's AOCs aim to revolutionize oligonucleotide therapies, potentially leading to impactful treatments for severe diseases.

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FAQ

What is the current stock price of Avidity Biosciences (RNA)?

The current stock price of Avidity Biosciences (RNA) is $31.35 as of December 24, 2024.

What is the market cap of Avidity Biosciences (RNA)?

The market cap of Avidity Biosciences (RNA) is approximately 3.7B.

What is Avidity Biosciences, Inc.?

Avidity Biosciences, Inc. is a biopharmaceutical company pioneering RNA therapeutics with its proprietary Antibody Oligonucleotide Conjugates (AOCs™) to treat serious genetic diseases.

What are Antibody Oligonucleotide Conjugates (AOCs™)?

AOCs™ combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies, enabling targeted treatment of diseases previously unreachable with existing RNA therapies.

What is AOC 1001 (Del-desiran)?

AOC 1001 (Del-desiran) is Avidity's lead product candidate for treating Myotonic Dystrophy Type 1 (DM1). It has shown promising results in clinical trials and is entering global Phase 3 HARBOR™ trial.

What are the key clinical programs of Avidity Biosciences?

The key clinical programs include AOC 1001 for DM1, AOC 1044 for Duchenne Muscular Dystrophy (DMD) with exon 44 skipping, and AOC 1020 for Facioscapulohumeral Muscular Dystrophy (FSHD).

What designations has AOC 1044 received?

AOC 1044 has received Rare Pediatric Disease, Orphan Drug, and Fast Track designations from the FDA and EMA for its potential to treat Duchenne Muscular Dystrophy (DMD) with exon 44 skipping.

What is the significance of the MARINA-OLE™ trial?

The MARINA-OLE™ trial demonstrated that AOC 1001 (Del-desiran) can reverse disease progression in Myotonic Dystrophy Type 1 (DM1) patients, showing improvements in key metrics such as video hand opening time (vHOT) and muscle strength.

What other areas is Avidity Biosciences expanding into?

In addition to rare muscle diseases, Avidity Biosciences is expanding its pipeline to include cardiology and immunology programs through internal discovery efforts and key partnerships.

Where is Avidity Biosciences headquartered?

Avidity Biosciences is headquartered in San Diego, CA.

How is Avidity Biosciences funded?

Avidity Biosciences is supported by top-tier investors and partnerships, recently completing an oversubscribed equity raise of $400 million, securing its financial position to fund operations into late 2026.

How can I learn more about Avidity Biosciences?

For more information, visit their official website at www.aviditybiosciences.com.

Avidity Biosciences, Inc.

Nasdaq:RNA

RNA Rankings

RNA Stock Data

3.74B
112.48M
4.83%
106.49%
12.17%
Biotechnology
Pharmaceutical Preparations
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United States of America
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