RNA

SAN DIEGO, May 14, 2026 /PRNewswire/ -- Atrium Therapeutics, Inc. (Nasdaq: RNA) ("Atrium," "Atrium Therapeutics" or the "Company"), a biopharmaceutical company advancing precision cardiology by developing RNA therapeutics targeted to the heart, today reported financial results for the first quarter ended March 31, 2026, and highlighted recent corporate progress following its launch as a public company. "Our focused pipeline, strong cash balance and experienced team are driving significant momentum as we build a dedicated precision cardiology company," said Kathleen Gallagher, President and Chief Executive Officer of Atrium Therapeutics. "This quarter, we advanced our lead development programs, ATR 1072 and ATR 1086, while establishing the strategic and operational foundation required to pioneer RNA therapeutics in the precision cardiology space. With a clear strategy, a well-characterized RNA delivery platform and a deep commitment to patients, we believe we are well-positioned to advance therapies for people living with genetic cardiomyopathies who have limited or no therapeutic options." Recent Highlights Launched as an independent, publicly traded precision cardiology company. Atrium launched on February 27, 2026 following its separation and spin-off from Avidity Biosciences, Inc. (Avidity) after Novartis AG's acquisition of Avidity. Atrium began trading on the Nasdaq Global Select Market under the ticker symbol "RNA." Earned $15 million milestone payment from Bristol Myers Squibb (BMS). Atrium successfully delivered the first development candidate targeting a cardiology indication under its ongoing collaboration with BMS, triggering a $15 million milestone payment. Under the terms of the agreement, Atrium is eligible to receive up to approximately $1.35 billion in research and development milestone payments, up to approximately $825 million in commercial milestone payments, and tiered royalties up to low double-digits on net sales. Progressed ATR 1072 program toward the clinic. Atrium has conducted the Good Laboratory Practice (GLP) toxicology studies required for the submission of an Investigational New Drug (IND) application for ATR 1072, a potential treatment designed to address the underlying genetic cause of Protein Kinase AMP-activated non-catalytic subunit Gamma 2 (PRKAG2) syndrome. Additionally, the Company has completed initial discussions with...

Del-desiran effectively delivered siRNA to muscle, resulting in approximately 40% mean reduction in DMPK mRNA and amelioration of missplicing Treatment demonstrated improvements in multiple measures including myotonia, muscle function and strength, mobility and patient-reported outcomes Del-desiran showed acceptable safety and tolerability with most adverse events mild or moderate SAN DIEGO, Feb. 18, 2026 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced that the final results from the completed Phase 1/2 MARINA® trial of delpacibart etedesiran (del-desiran) in people living with myotonic dystrophy type 1 (DM1) will be published in the February 19 issue of The New England Journal of Medicine (NEJM). The manuscript is titled "An Antibody Oligonucleotide Conjugate for Myotonic Dystrophy Type 1." DM1 is an underrecognized, progressive and often fatal neuromuscular disease with no disease modifying therapies. Del-desiran is an investigational treatment designed to address the underlying genetic root cause of DM1 by reducing total levels of the toxic, DMPK (myotonic dystrophy protein kinase) mRNA. The accumulation of these toxic mRNA sequester key RNA-regulatory proteins that subsequently lead to missplicing of several downstream genes, resulting in the diverse clinical manifestations of disease. The Phase 1/2 MARINA trial was a randomized, double-blind, placebo-controlled study designed to evaluate the safety and tolerability of single and multiple ascending doses of del-desiran administered intravenously in adults with DM1 for six months. Data were assessed from 38 participants who were randomized 3:1 to receive one dose of 1 mg/kg del-desiran, three doses of either 2 mg/kg del-desiran or 4 mg/kg del-desiran (reflected as siRNA dose), or placebo. The primary endpoint of the study was to evaluate the safety and tolerability of del-desiran. Exploratory endpoints were to evaluate the clinical activity of del-desiran across multiple efficacy measures. "These final results from the MARINA study further reinforce del-desiran data reported thus far showing acceptable safety profile and improvements across a range of key functional assessments including myotonia, a hallmark symptom of DM1," said Nicholas E. Johns...

Announced Novartis agreement to acquire Avidity for total equity value of approximately $12 billion; Avidity expects to separate its early-stage precision cardiology programs into a new public company ("SpinCo") Clear path forward aligned with FDA following pre-BLA meeting for del-zota, with BLA submission planned for 2026 Del-zota one-year data demonstrated sustained muscle protection leading to meaningful improvement and reversal of disease progression across multiple key functional measures Strong balance sheet with ~$1.9 billion in cash, cash equivalents, and marketable securities SAN DIEGO, Nov. 10, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™) to profoundly improve people's lives, today reported financial results for the third quarter ended September 30, 2025, and highlighted recent progress. "In October, we announced that Avidity entered into a definitive merger agreement with Novartis, which we believe maximizes value for our investors, accelerates the global reach of our innovative neuroscience pipeline, and advances even more possibilities for our innovative science," said Sarah Boyce, president and chief executive officer of Avidity. "This important transaction, alongside compelling del-zota data and a successful pre-BLA meeting with the FDA in the third quarter, underscores the remarkable consistency of our AOC platform and the significant potential of del-zota, del-desiran, and del-brax to transform outcomes for people living with serious rare diseases. These achievements are possible because of our incredibly talented Avidity team and the close collaboration of the dedicated patient and clinical communities we serve." Company Announcements, Highlights and Upcoming Milestones Definitive Merger Agreement with Novartis AG In October 2025, Avidity announced it had entered into a definitive merger agreement with Novartis AG ("Novartis") which was unanimously approved by the Boards of Directors of both Avidity and Novartis. The closing of the acquisition will follow the separation of Avidity's early-stage precision cardiology programs into SpinCo, which is expected to be a publicly traded company. SpinCo will be led by Kathleen Gallagher, currently Avidity's chief program officer, as chief executive of...

The market expects Avidity Biosciences, Inc. (RNA) to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended September 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $1.07 per share in its upcoming report, which represents a year-over-year change of -64.6%. Revenues are expected to be $2.5 million, up 6.8% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 3.39% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP r...

Swiss pharma giant Novartis AG NVS reported core earnings per share (excluding one-time charges) of $2.25 in the third quarter, which missed the Zacks Consensus Estimate by a penny. Nonetheless, the figure was up from $2.06 reported a year ago. The year-over-year improvement was driven by growth in sales. Revenues of $13.9 billion climbed 8% from the year-ago reported figure and marginally beat the Zacks Consensus Estimate. On a constant currency basis, sales increased 7%, driven by continued strong performances from Kisqali, Kesimpta, Scemblix, and Pluvicto, which more than offset the adverse impact of generic competition for Promacta, Tasigna, and Entresto in the United States. Core Operating income was up 7% to $5.5 billion. Shares of Novartis have gained 35.9% year to date compared with the industry’s growth of 7.9%. Image Source: Zacks Investment Research All growth rates mentioned below are on a year-over-year basis and at constant exchange rates. With the successful spin-off of the Sandoz business in 2023, Novartis now focuses on four core therapeutic areas — cardiovascular-renal-metabolic, immunology, neuroscience and oncology. Cardiovascular drug Entresto’s sales decreased 1% from the year-ago level to $1.9 billion as sales were impacted by generic competition in the United States. Sales grew outside the country where the drug is approved for heart failure globally as well as hypertension in China and Japan. Novartis is in a litigation with a generic manufacturer and FDA in the United States to protect its Entresto IP and regulatory rights. Entresto’s sales missed the Zacks Consensus Estimate of $2.1 billion and our model estimate of $2 billion. Cosentyx’s sales (psoriasis, spondylitis and arthritis) were down 1% to $1.7 billion as sales growth was negatively impacted by a one-time revenue deduction adjustment in the United States. Excluding this adjustment, Cosentyx sales were up 4%. Cosentyx’s sales missed the Zacks Consensus Estimate of $1.72 billion and our model estimate of $1.73 billion. Kisqali (breast cancer) maintained its stellar performance, with sales surging 68% to $1.33 billion. Sales grew across all regions, driven by exemplary growth in the United States with strong momentum from the recently launched early breast cancer (eBC) indication as well as continued share gains in the metastatic breast cancer indication. Kisqali sales beat t...

The investors in Avidity Biosciences, Inc.'s (NASDAQ:RNA) will be rubbing their hands together with glee today, after the share price leapt 29% to US$46.29 in the week following its quarterly results. Revenues came in 140% better than analyst models expected, at US$3.8m, although statutory losses ballooned 24% to US$1.21, which is much worse than what was forecast. This is an important time for investors, as they can track a company's performance in its report, look at what experts are forecasting for next year, and see if there has been any change to expectations for the business. We've gathered the most recent statutory forecasts to see whether the analysts have changed their earnings models, following these results. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. Following the recent earnings report, the consensus from 13 analysts covering Avidity Biosciences is for revenues of US$10.1m in 2025. This implies a perceptible 6.3% decline in revenue compared to the last 12 months. Per-share losses are expected to explode, reaching US$4.65 per share. Before this earnings announcement, the analysts had been modelling revenues of US$7.27m and losses of US$3.98 per share in 2025. Ergo, there's been a clear change in sentiment, with the analysts lifting this year's revenue estimates, while at the same time increasing their loss per share numbers to reflect the cost of achieving this growth. View our latest analysis for Avidity Biosciences There was no major change to the consensus price target of US$67.00, with growing revenues seemingly enough to offset the concern of growing losses. The consensus price target is just an average of individual analyst targets, so - it could be handy to see how wide the range of underlying estimates is. Currently, the most bullish analyst values Avidity Biosciences at US$96.00 per share, while the most bearish prices it at US$50.00. This is a fairly broad spread of estimates, suggesting that analysts are forecasting a wide range of possible outcomes for the business. Another way we can view these estimates is in the context of the bigger picture, such as how the forecasts stack up against past performance, and whether forecasts are more or less bullish relative to other companies in the industry. These estimates imply that revenue is expected to slow, with a forecast...

Aligned with FDA on del-brax accelerated and full approval pathways for FSHD, reported positive topline data from Phase 1/2 FORTITUDE™ trial, and initiated global confirmatory Phase 3 study Planned del-zota BLA submission at year end 2025 for DMD44 on track to be Avidity's first BLA submission On track for three potential BLA submissions over a 12-month period Strong balance sheet and cash runway to mid-2027 enabling global commercial launch readiness; first potential commercial launch in U.S. in 2026 SAN DIEGO, Aug. 7, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™) to profoundly improve people's lives, today reported financial results for the second quarter ended June 30, 2025 and highlighted recent progress. "Avidity continues to deliver on its leadership in RNA therapeutics as we prepare for three potential BLA submissions in a 12-month period with strong clinical data, regulatory progress, and operational execution," said Sarah Boyce, president and chief executive officer of Avidity. "Our programs in FSHD, DMD44 and DM1 each made meaningful advances during the second quarter of 2025, and we are encouraged by the consistent and reproducible data across these late-stage neuromuscular programs. We are keenly aware of the challenges facing patients and families living with these conditions and are preparing for potential commercialization with great thoughtfulness and urgency." "Avidity continues to operate from a position of financial strength," said Mike MacLean, chief financial officer at Avidity. "Avidity's recent topline data for del-brax continues to demonstrate the consistency of the platform. As we move quickly toward potentially three successive launches starting in 2026, we continue to make meaningful progress in building our global infrastructure." Company Highlights Delpacibart zotadirsen (del-zota) for the treatment of people living with Duchenne muscular dystrophy with mutations amenable to exon 44 skipping (DMD44): In July 2025, Avidity announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to del-zota Remain on track for planned BLA submission at year end 2025, which will be Avidity's first BLA Plan to present topline and functional data from the ongoing E...

Net loss: US$115.8m (loss widened by 68% from 1Q 2024). US$0.90 loss per share (further deteriorated from US$0.79 loss in 1Q 2024). AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 40%. Earnings per share (EPS) also missed analyst estimates by 6.3%. Looking ahead, revenue is forecast to grow 61% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 13% from a week ago. We should say that we've discovered 2 warning signs for Avidity Biosciences that you should be aware of before investing here. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

On track to deliver key regulatory updates for del-brax and topline data from dose escalation cohorts in the FORTITUDE™ trial in the second quarter Positive topline del-zota data further supports first BLA submission at year end 2025 – continues to highlight reproducibility and consistency across three late-stage clinical trials for DMD44, DM1 and FSHD Executing on global commercial infrastructure development and on track with preparations for first potential commercial launch in U.S. in 2026 Strong balance sheet supports execution across three late-stage clinical programs and commercial launch preparations with cash runway into mid-2027 SAN DIEGO, May 8, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™) to profoundly improve people's lives, today reported financial results for the first quarter ended March 31, 2025, highlighting recent progress. "We continue to build on the consistent and reproducible data readouts from our platform across all three of our clinical programs for DMD44, DM1 and FSHD, and are executing on our transition to become a global commercial organization. In March 2025, we shared positive topline EXPLORE44® Phase 1/2 del-zota data demonstrating remarkable and consistent improvements across multiple measures including a substantial increase in dystrophin production and reduction in creatine kinase levels to near normal, which will support our planned BLA submission at year end 2025 and reinforces del-zota's potential to become a groundbreaking treatment for people living with DMD44," said Sarah Boyce, president and chief executive officer at Avidity. "We look forward to delivering on multiple milestones this year and remain on track to share several key regulatory updates for del-brax in the second quarter that include a potential accelerated approval path in U.S., alignment on the design of the global Phase 3 trial and initiation of the trial. We are also planning to share topline del-brax data from the FORTITUDE™ dose escalation cohorts in the second quarter." "2025 is a pivotal year for Avidity as we build out our global commercial infrastructure to support three potential product launches for del-zota, del-desiran and del-brax. With a strong balance sheet and a cash balance of approximate...