Avidity Biosciences Launches U.S. Managed Access Program for Investigational Therapy del-zota in DMD44
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 19 2025
0mins
Should l Buy RNA?
Source: Newsfilter
Avidity Biosciences Launches Managed Access Program: Avidity Biosciences has announced a Managed Access Program (MAP) for its investigational therapy delpacibart zotadirsen (del-zota) aimed at eligible patients with Duchenne muscular dystrophy mutations amenable to exon 44 skipping (DMD44) in the U.S., with enrollment expected to begin by the end of 2025.
Del-zota's Clinical Development and FDA Interaction: Following a pre-BLA meeting with the FDA, Avidity plans to submit a Biologics License Application (BLA) for del-zota in 2026, seeking accelerated approval, while participants in ongoing trials will have the option to transition to the MAP upon completion of their treatment.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy RNA?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on RNA
Wall Street analysts forecast RNA stock price to rise
13 Analyst Rating
2 Buy
11 Hold
0 Sell
Hold
Current: 72.910
Low
72.00
Averages
74.42
High
96.00
Current: 72.910
Low
72.00
Averages
74.42
High
96.00
About RNA
Avidity Biosciences, Inc. is a biopharmaceutical company. The Company is engaged in delivering a new class of ribonucleic acid (RNA) therapeutics called antibody oligonucleotide conjugates (AOCs). The AOCs are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. Its advancing and expanding pipeline has three programs in clinical development. The Del-desiran is designed to treat people with myotonic dystrophy type 1 (DM1) and is in the global Phase III HARBOR trial and in the ongoing MARINA-OLE trial in people with DM1. The Delpacibart braxlosiran is the first investigational therapy designed to directly target DUX4 in people living with facioscapulohumeral muscular dystrophy (FSHD). The Del-zota is designed for people with Duchenne muscular dystrophy (DMD) and is in development with the Phase II EXPLORE44 open-label extension (OLE) study.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Avidity Biosciences Announces Share Distribution for Spin-Off
- Share Distribution Announcement: Avidity Biosciences has announced a share distribution on February 12, 2026, where holders of Avidity common stock will receive one share of Atrium Therapeutics for every ten shares held, aimed at enhancing company value through the spin-off.
- Merger Progress: This share distribution is linked to Avidity's acquisition by Novartis, with completion contingent on specific conditions including shareholder approval, indicating the company's strategic positioning in merger integration.
- Innovative Drug Platform: Avidity's Antibody Oligonucleotide Conjugates (AOCs™) platform is advancing clinical projects targeting rare muscle diseases, showcasing its innovative capabilities in RNA therapeutics, which could yield long-term growth potential for the company.
- Market Outlook: Through collaboration with Novartis, Avidity plans to expand its pipeline in cardiology and immunology, further enhancing its market competitiveness and addressing the growing healthcare demands.
See More
Avidity Biosciences Announces Spin-Off Plan
- Shareholder Distribution Plan: Avidity Biosciences has announced a record date of February 12, 2026, for the pro rata distribution of Atrium Therapeutics shares, providing one share for every ten Avidity shares held, aimed at enhancing shareholder value and preparing for the upcoming merger.
- Merger and Spin-Off Progress: The completion of the merger and spin-off is subject to specific closing conditions, including Avidity shareholder approval, indicating the company's strategic focus on resource integration and business optimization, which may impact future market performance.
- Innovative Drug Platform: Avidity's Antibody Oligonucleotide Conjugates (AOCs™) platform is advancing clinical projects targeting rare muscle diseases, showcasing the company's technological leadership in biopharmaceuticals, which is expected to drive future revenue growth.
- Market Outlook: Through the merger with Novartis, Avidity aims to expand its influence in the precision cardiology sector, potentially attracting more investor interest in its long-term growth prospects and enhancing its competitive position in the market.
See More
Halper Sadeh LLC Investigates Multiple Companies for Securities Violations
- Two Harbors Transaction: Halper Sadeh LLC is investigating Two Harbors Investment Corp. (NYSE: TWO) for its sale to UWM Holdings Corporation, which involves an exchange of 2.3328 shares of UWM Class A Common Stock for each share of Two Harbors common stock, potentially indicating breaches of fiduciary duties to shareholders.
- Avidity Biosciences Acquisition: Avidity Biosciences, Inc. (NASDAQ: RNA) is being sold to Novartis for $72.00 per share in cash, and Halper Sadeh LLC is assessing the implications of this transaction on shareholder rights and options.
- CVB Financial Merger: CVB Financial Corp. (NASDAQ: CVBF) is merging with Heritage Commerce Corp., which will result in CVB shareholders owning approximately 77% of the combined entity, prompting Halper Sadeh LLC to investigate the compliance of this merger.
- Tamboran Resources Merger: Tamboran Resources Corporation (NYSE: TBN) is merging with Falcon Oil & Gas Ltd., allowing Tamboran shareholders to own 73.2% of the combined company, and Halper Sadeh LLC may seek increased compensation and disclosures for shareholders regarding this deal.
See More
Earnings Momentum Review: BAX and Others Rated D
- Earnings Momentum Ratings: As the earnings season kicks off, Baxter International (BAX) and others are rated D for earnings momentum, indicating significant pressure on profitability that may undermine investor confidence.
- Multiple Companies Rated: Companies like Biogen (BIIB), Natera (NTRA), and Revolution Medicines (RVMD) also received D ratings, suggesting a notable decline in earnings expectations that could lead to stock price volatility.
- Market Impact: These ratings reflect a broader weakening of earnings momentum in the healthcare sector, potentially affecting the performance of related healthcare ETFs (such as XLV, VHT), prompting investors to reassess risks.
- Industry Outlook: As the earnings season progresses, market attention on healthcare stocks, particularly those with weak earnings momentum, may trigger broader industry adjustments and shifts in investment strategies.
See More
Biotech Stocks Surge at Year-End 2025, ETFs Gain 35.84%
- Sector Recovery: The iShares Biotechnology ETF surged 29.51% year-to-date by December 2025, while the State Street SPDR S&P Biotech ETF achieved an even higher gain of 35.84%, indicating a significant recovery in investor confidence in the biotech sector.
- Surge in M&A Activity: Six of the year's ten largest biopharma deals occurred in Q4, with Johnson & Johnson spending $14.6 billion on Intra Cellular Therapies, signaling a strong commitment from big pharma to expand their pipelines through acquisitions.
- FDA Approvals Boost Innovation: The FDA approved 44 new therapies in 2025, with 26 approvals in the second half, including Cytokinetics' Myqorzo after 27 years, highlighting a supportive regulatory environment for innovation.
- Clinical Trial Successes: Structure Therapeutics saw its stock more than double after its obesity drug trials showed over 15% weight loss in patients, demonstrating the direct impact of clinical success on company valuations.
See More
Two Health Care Stocks That Could Cause You Concern This December
Avidity Biosciences Overview: Avidity Biosciences reported a quarterly loss of $1.27 per share, missing estimates, but its sales of $12.475 million exceeded expectations. The stock has surged 141% over six months, with an RSI of 76, indicating it may be overbought.
Henry Schein Overview: Henry Schein received an Overweight rating from Barclays with a price target of $86. The stock has increased by 6% recently and has a 52-week high of $82.49, with an RSI of 71.1, suggesting it is also nearing overbought territory.
Momentum Indicator Explanation: The Relative Strength Index (RSI) is a momentum indicator that helps traders assess stock performance by comparing price strength on up days versus down days, with values above 70 indicating overbought conditions.
Market Context: The article highlights the potential risks for investors in the health care sector, particularly focusing on stocks that may be overvalued based on their momentum indicators.
See More
Avidity Biosciences Announces Share Distribution for Spin-Off
- Share Distribution Announcement: Avidity Biosciences has announced a share distribution on February 12, 2026, where holders of Avidity common stock will receive one share of Atrium Therapeutics for every ten shares held, aimed at enhancing company value through the spin-off.
- Merger Progress: This share distribution is linked to Avidity's acquisition by Novartis, with completion contingent on specific conditions including shareholder approval, indicating the company's strategic positioning in merger integration.
- Innovative Drug Platform: Avidity's Antibody Oligonucleotide Conjugates (AOCs™) platform is advancing clinical projects targeting rare muscle diseases, showcasing its innovative capabilities in RNA therapeutics, which could yield long-term growth potential for the company.
- Market Outlook: Through collaboration with Novartis, Avidity plans to expand its pipeline in cardiology and immunology, further enhancing its market competitiveness and addressing the growing healthcare demands.
See More
Avidity Biosciences Announces Spin-Off Plan
- Shareholder Distribution Plan: Avidity Biosciences has announced a record date of February 12, 2026, for the pro rata distribution of Atrium Therapeutics shares, providing one share for every ten Avidity shares held, aimed at enhancing shareholder value and preparing for the upcoming merger.
- Merger and Spin-Off Progress: The completion of the merger and spin-off is subject to specific closing conditions, including Avidity shareholder approval, indicating the company's strategic focus on resource integration and business optimization, which may impact future market performance.
- Innovative Drug Platform: Avidity's Antibody Oligonucleotide Conjugates (AOCs™) platform is advancing clinical projects targeting rare muscle diseases, showcasing the company's technological leadership in biopharmaceuticals, which is expected to drive future revenue growth.
- Market Outlook: Through the merger with Novartis, Avidity aims to expand its influence in the precision cardiology sector, potentially attracting more investor interest in its long-term growth prospects and enhancing its competitive position in the market.
See More
Halper Sadeh LLC Investigates Multiple Companies for Securities Violations
- Two Harbors Transaction: Halper Sadeh LLC is investigating Two Harbors Investment Corp. (NYSE: TWO) for its sale to UWM Holdings Corporation, which involves an exchange of 2.3328 shares of UWM Class A Common Stock for each share of Two Harbors common stock, potentially indicating breaches of fiduciary duties to shareholders.
- Avidity Biosciences Acquisition: Avidity Biosciences, Inc. (NASDAQ: RNA) is being sold to Novartis for $72.00 per share in cash, and Halper Sadeh LLC is assessing the implications of this transaction on shareholder rights and options.
- CVB Financial Merger: CVB Financial Corp. (NASDAQ: CVBF) is merging with Heritage Commerce Corp., which will result in CVB shareholders owning approximately 77% of the combined entity, prompting Halper Sadeh LLC to investigate the compliance of this merger.
- Tamboran Resources Merger: Tamboran Resources Corporation (NYSE: TBN) is merging with Falcon Oil & Gas Ltd., allowing Tamboran shareholders to own 73.2% of the combined company, and Halper Sadeh LLC may seek increased compensation and disclosures for shareholders regarding this deal.
See More
Earnings Momentum Review: BAX and Others Rated D
- Earnings Momentum Ratings: As the earnings season kicks off, Baxter International (BAX) and others are rated D for earnings momentum, indicating significant pressure on profitability that may undermine investor confidence.
- Multiple Companies Rated: Companies like Biogen (BIIB), Natera (NTRA), and Revolution Medicines (RVMD) also received D ratings, suggesting a notable decline in earnings expectations that could lead to stock price volatility.
- Market Impact: These ratings reflect a broader weakening of earnings momentum in the healthcare sector, potentially affecting the performance of related healthcare ETFs (such as XLV, VHT), prompting investors to reassess risks.
- Industry Outlook: As the earnings season progresses, market attention on healthcare stocks, particularly those with weak earnings momentum, may trigger broader industry adjustments and shifts in investment strategies.
See More
Biotech Stocks Surge at Year-End 2025, ETFs Gain 35.84%
- Sector Recovery: The iShares Biotechnology ETF surged 29.51% year-to-date by December 2025, while the State Street SPDR S&P Biotech ETF achieved an even higher gain of 35.84%, indicating a significant recovery in investor confidence in the biotech sector.
- Surge in M&A Activity: Six of the year's ten largest biopharma deals occurred in Q4, with Johnson & Johnson spending $14.6 billion on Intra Cellular Therapies, signaling a strong commitment from big pharma to expand their pipelines through acquisitions.
- FDA Approvals Boost Innovation: The FDA approved 44 new therapies in 2025, with 26 approvals in the second half, including Cytokinetics' Myqorzo after 27 years, highlighting a supportive regulatory environment for innovation.
- Clinical Trial Successes: Structure Therapeutics saw its stock more than double after its obesity drug trials showed over 15% weight loss in patients, demonstrating the direct impact of clinical success on company valuations.
See More
Two Health Care Stocks That Could Cause You Concern This December
Avidity Biosciences Overview: Avidity Biosciences reported a quarterly loss of $1.27 per share, missing estimates, but its sales of $12.475 million exceeded expectations. The stock has surged 141% over six months, with an RSI of 76, indicating it may be overbought.
Henry Schein Overview: Henry Schein received an Overweight rating from Barclays with a price target of $86. The stock has increased by 6% recently and has a 52-week high of $82.49, with an RSI of 71.1, suggesting it is also nearing overbought territory.
Momentum Indicator Explanation: The Relative Strength Index (RSI) is a momentum indicator that helps traders assess stock performance by comparing price strength on up days versus down days, with values above 70 indicating overbought conditions.
Market Context: The article highlights the potential risks for investors in the health care sector, particularly focusing on stocks that may be overvalued based on their momentum indicators.
See More
