Avidity Biosciences(RNA)
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Top 2 Health Care Stocks That May Keep You Up At Night In December
Benzinga· 2025-12-16 13:30
分组1 - Two stocks in the health care sector are signaling potential warnings for momentum-focused investors as of December 16, 2025 [1] - The Relative Strength Index (RSI) is a key momentum indicator, with values above 70 indicating that a stock may be overbought [2] - Avidity Biosciences reported quarterly losses of $1.27 per share, missing the analyst consensus estimate of $1.11, but its quarterly sales of $12.475 million exceeded expectations of $1.932 million [5] - Avidity's stock has increased approximately 141% over the past six months, with a 52-week high of $71.90, and currently has an RSI value of 76 [5] - Henry Schein's stock has gained around 6% over the past five days, reaching a 52-week high of $82.49, with an RSI value of 71.1 [5] 分组2 - Avidity Biosciences has entered into a merger agreement with Novartis, which is expected to enhance value for investors and expand its neuroscience pipeline [5] - Barclays analyst initiated coverage on Henry Schein with an Overweight rating and a price target of $86 [5] - Avidity's stock closed at $71.86, while Henry Schein's shares closed at $77.39 on the same day [5]
Top 2 Health Care Stocks That May Keep You Up At Night In December - Henry Schein (NASDAQ:HSIC), Paranovus Entertainment (NASDAQ:PAVS)
Benzinga· 2025-12-16 13:30
As of Dec. 16, 2025, two stocks in the health care sector could be flashing a real warning to investors who value momentum as a key criteria in their trading decisions.The RSI is a momentum indicator, which compares a stock’s strength on days when prices go up to its strength on days when prices go down. When compared to a stock’s price action, it can give traders a better sense of how a stock may perform in the short term. An asset is typically considered overbought when the RSI is above 70, according to B ...
Avidity Biosciences, Inc. (RNA): A Bull Case Theory
Yahoo Finance· 2025-12-04 18:59
We came across a bullish thesis on Avidity Biosciences, Inc. on BiotechBonanza’s Substack by AnotherBio. In this article, we will summarize the bulls’ thesis on RNA. Avidity Biosciences, Inc.'s share was trading at $71.54 as of December 2nd. microscope, health Tonhom1009/Shutterstock.com Novartis is acquiring Avidity RNA, a pre-Phase 3 biotech company, in a straightforward deal with no overlap between the two businesses. The transaction is expected to close in the first half of 2026, though timing unce ...
Novartis Extends Growth Visibility, Reinforces Confidence in Pharma Momentum
Investing· 2025-11-20 07:05
Group 1 - The article provides a market analysis focusing on Novartis AG ADR, highlighting its performance and potential investment opportunities within the healthcare sector [1] - The Health Care Select Sector SPDR® Fund is discussed as a key investment vehicle, reflecting trends and movements in the healthcare industry [1] - iShares Genomics Immunology and Healthcare ETF is analyzed for its role in capturing growth in genomics and immunology, indicating a shift towards innovative healthcare solutions [1]
Avidity Biosciences Announces U.S. Managed Access Program (MAP) for Investigational Therapy del-zota in DMD44
Prnewswire· 2025-11-19 14:13
Core Insights - Avidity Biosciences has launched a Managed Access Program (MAP) for its investigational therapy delpacibart zotadirsen (del-zota) aimed at individuals with Duchenne muscular dystrophy mutations amenable to exon 44 skipping (DMD44) in the U.S. [1][2] - The MAP is designed to provide del-zota to eligible patients quickly, with enrollment expected to begin by the end of 2025 [2][3] - Avidity plans to submit a Biologics License Application (BLA) for del-zota in 2026 following a pre-BLA meeting with the FDA [3] Company Overview - Avidity Biosciences focuses on developing a new class of RNA therapeutics known as Antibody Oligonucleotide Conjugates (AOCs) [6] - The company aims to address previously unreachable targets and diseases using its proprietary AOC platform [6] - Avidity is advancing clinical programs for rare muscle diseases, including Duchenne muscular dystrophy, and has received multiple designations from the FDA for del-zota [5][6] Product Details - Del-zota is designed to skip exon 44 of the dystrophin gene, enabling dystrophin production in patients with DMD44 [5] - The Phase 1/2 EXPLORE44 trial demonstrated significant increases in dystrophin production and improvements in muscle function, with a favorable safety profile [5] - Del-zota has received designations such as Rare Pediatric Disease, Orphan Drug, Fast Track, and Breakthrough Therapy from the FDA [5]
Avidity Biosciences, Inc. (RNA) Reports Q3 Loss, Beats Revenue Estimates
ZACKS· 2025-11-11 00:56
Core Insights - Avidity Biosciences reported a quarterly loss of $1.27 per share, which was worse than the Zacks Consensus Estimate of a loss of $1.05, and a significant increase from a loss of $0.65 per share a year ago, indicating a negative earnings surprise of -20.95% [1] - The company achieved revenues of $12.48 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 399%, and showing substantial growth from $2.34 million in the same quarter last year [2] - Avidity Biosciences shares have increased by approximately 140.2% year-to-date, significantly outperforming the S&P 500's gain of 14.4% [3] Financial Performance - Over the last four quarters, Avidity Biosciences has surpassed consensus EPS estimates only once, while it has topped revenue estimates three times [2] - The current consensus EPS estimate for the upcoming quarter is -$1.00 on revenues of $2.65 million, and for the current fiscal year, it is -$4.30 on revenues of $8.79 million [7] Industry Context - Avidity Biosciences operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the top 36% of over 250 Zacks industries, suggesting a favorable industry outlook [8] - The performance of Avidity Biosciences' stock may be influenced by the overall industry trends, as empirical research indicates a strong correlation between near-term stock movements and earnings estimate revisions [5][8]
Avidity Biosciences(RNA) - 2025 Q3 - Quarterly Report
2025-11-10 21:12
Drug Development and Clinical Trials - The company is developing a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs) targeting previously untreatable diseases[85]. - Delpacibart zotadirsen (del-zota) is in Phase 2 development for Duchenne muscular dystrophy (DMD) and has shown a 25% increase in dystrophin production and over 80% reduction in creatine kinase levels compared to baseline[92]. - The FDA granted Breakthrough Therapy designation to del-zota for the treatment of DMD44 in July 2025[94]. - Delpacibart etedesiran (del-desiran) is currently in a global Phase 3 trial for myotonic dystrophy type 1 (DM1) with a focus on multiple key functional aspects[96]. - The HARBOR trial for del-desiran involves 159 participants and is designed to assess myotonia and muscle strength, with a primary endpoint of video hand opening time (vHOT)[96]. - The company plans to submit a protocol amendment for the HARBOR trial to extend the data cutoff from 30 weeks to 54 weeks, enhancing the safety and efficacy data[99]. - The Phase 3 HARBOR trial is fully enrolled with 159 participants, and multiple updates from the del-desiran program are expected[100]. - The del-brax program received FDA alignment on accelerated and full approval pathways, with positive topline Phase 1/2 data showing improvements compared to placebo[101]. - Topline data from the FORTITUDE biomarker cohort is anticipated in Q2 2026, while FORTITUDE-3 data readout and global regulatory submissions are expected in 2028[102]. - The FORTITUDE-3 study will evaluate del-brax in approximately 200 participants, assessing key FSHD-related endpoints over 18 months[108]. Financial Performance and Funding - The company reported net losses of $322.3 million and $212.2 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $1.3 billion as of September 30, 2025[112]. - Existing cash, cash equivalents, and marketable securities amount to approximately $1.9 billion, expected to fund operations for at least 12 months[114]. - The company entered into a collaboration with Bristol Myers Squibb, receiving approximately $100 million upfront and potential milestone payments totaling up to $1.35 billion[115]. - Under the collaboration with Eli Lilly, the company is eligible for up to $60 million in development milestone payments per target and tiered royalties on net sales[116]. - Revenue increased by $10.1 million and $10.0 million for the three and nine months ended September 30, 2025, primarily due to the recognition of a $10.0 million milestone under the Lilly Agreement[128]. - Research and development expenses increased by $77.8 million for the three months ended September 30, 2025, primarily due to increased external costs associated with clinical trials and preclinical studies[130]. - General and administrative expenses increased by $23.1 million for the three months ended September 30, 2025, primarily due to $11.4 million in higher personnel costs[131]. - Other income decreased by $3.4 million for the three months ended September 30, 2025, primarily due to lower interest income earned on marketable securities[132]. - Net cash used in operating activities was $480.7 million for the nine months ended September 30, 2025, primarily due to increased research and development costs[140]. - Net cash used in investing activities was $245.3 million for the nine months ended September 30, 2025, primarily for purchases of marketable securities[141]. - Net cash provided by financing activities was $856.1 million for the nine months ended September 30, 2025, consisting of $837.4 million in net proceeds from sales of common stock[142]. - The company sold 5,646,583 shares of common stock under the 2024 Sales Agreement, receiving net proceeds of $185.5 million[133]. - On September 15, 2025, the company completed a public offering of 17,250,000 shares at a price of $40.00 per share, netting approximately $651.4 million[134]. Mergers and Agreements - A merger agreement with Novartis AG was entered into on October 25, 2025, with expected closure in the first half of 2026[86]. - The merger includes a spin-off of early-stage precision cardiology programs, with a proposed distribution ratio of 1 share of SpinCo for every 10 shares of the company’s common stock[87]. - A termination fee of $450 million is stipulated in the merger agreement, while a reverse termination fee of $600 million is applicable under certain conditions[88]. Operational Commitments and Changes - The company entered into a sublease agreement in April 2024 with total future lease commitments of approximately $79.2 million, commencing in August 2025[145]. - An additional 80,000 square feet was rented under an amended sublease agreement, with future lease commitments of approximately $53.7 million[145]. - A manufacturing agreement was established in August 2025 with a CMO, requiring minimum purchase obligations totaling approximately $621.6 million from 2026 to 2028[146]. - There have been no material changes to contractual obligations outside the ordinary course of business as of September 30, 2025[148]. - As of September 30, 2025, there have been no material changes in market risk from the previous annual report[150].
Avidity Biosciences(RNA) - 2025 Q3 - Quarterly Results
2025-11-10 21:07
Merger and Acquisition - Avidity entered into a definitive merger agreement with Novartis for a total equity value of approximately $12 billion[1]. - The expected closing of the Novartis acquisition is in the first half of 2026, contingent on the separation of Avidity's early-stage precision cardiology programs into a new public company, SpinCo[3]. Financial Performance - Collaboration revenues for Q3 2025 were $12.5 million, compared to $2.3 million for Q3 2024, primarily driven by a $10 million milestone from Eli Lilly[6]. - Collaboration revenue for Q3 2025 was $12.475 million, a significant increase from $2.336 million in Q3 2024, representing a growth of 434%[16]. - Total operating expenses for Q3 2025 reached $201.281 million, compared to $100.470 million in Q3 2024, indicating a 100% increase[16]. - Net loss for Q3 2025 was $174.442 million, compared to a net loss of $80.398 million in Q3 2024, reflecting a 117% increase in losses[16]. - Cash and cash equivalents as of September 30, 2025, were $350.158 million, up from $219.868 million at the end of 2024, showing a 59% increase[16]. - Total assets increased to $2.134 billion as of September 30, 2025, from $1.563 billion at the end of 2024, representing a growth of 36.5%[16]. - Total liabilities rose to $247.944 million as of September 30, 2025, compared to $138.936 million at the end of 2024, indicating an increase of 78.5%[16]. - The company reported other income of $14.364 million in Q3 2025, down from $17.736 million in Q3 2024, a decrease of 19.5%[16]. Research and Development - Research and development expenses for Q3 2025 were $154.9 million, up from $77.2 million in Q3 2024, reflecting increased costs for del-desiran, del-brax, and del-zota[6]. - Research and development expenses for the nine months ended September 30, 2025, were $392.563 million, up from $207.968 million in the same period of 2024, a 89% increase[16]. - Avidity plans to submit a BLA for del-zota in 2026 following a successful pre-BLA meeting with the FDA[4]. - Del-zota demonstrated sustained muscle protection and meaningful improvement in disease progression across multiple functional measures after one year of treatment[4]. - Avidity's del-desiran Phase 3 HARBOR trial completed enrollment in July 2025, with topline data expected in the second half of 2026[4]. - Avidity's del-brax is aligned with the FDA on accelerated and full approval pathways, with global regulatory submissions expected in 2028[4]. Administrative Expenses - General and administrative expenses for Q3 2025 were $46.3 million, compared to $23.3 million in Q3 2024, due to higher personnel and commercial infrastructure costs[6]. - General and administrative expenses for the nine months ended September 30, 2025, totaled $116.797 million, compared to $57.902 million in 2024, reflecting a 101% increase[16]. Shareholder Information - The weighted-average shares outstanding for Q3 2025 were 137.895 million, compared to 123.375 million in Q3 2024, an increase of 11.8%[16].
Avidity Biosciences Reports Third Quarter 2025 Financial Results and Recent Highlights
Prnewswire· 2025-11-10 21:05
Core Insights - Avidity Biosciences has entered into a definitive merger agreement with Novartis for a total equity value of approximately $12 billion, which is expected to maximize value for investors and enhance the global reach of Avidity's neuroscience pipeline [1][2][6] - Avidity's del-zota program has shown promising one-year data, demonstrating sustained muscle protection and significant improvement in disease progression for patients with Duchenne muscular dystrophy [1][6] - The company reported a strong balance sheet with approximately $1.9 billion in cash, cash equivalents, and marketable securities as of September 30, 2025, which is expected to fund operations until mid-2028 [1][6] Company Announcements - The merger with Novartis is set to close in the first half of 2026, following the separation of Avidity's early-stage precision cardiology programs into a new public company, SpinCo [1][6] - Avidity's CEO, Sarah Boyce, will transition to chair of the board of SpinCo, while Kathleen Gallagher will lead SpinCo as CEO [6] Financial Results - For the third quarter of 2025, Avidity reported collaboration revenues of $12.5 million, a significant increase from $2.3 million in the same period of 2024 [13] - Research and development expenses for Q3 2025 were $154.9 million, compared to $77.2 million in Q3 2024, reflecting increased costs associated with advancing key programs [13] - The net loss for Q3 2025 was $174.4 million, compared to a net loss of $80.4 million in Q3 2024 [13] Clinical Development Progress - Avidity's del-zota program has received Breakthrough Therapy designation from the FDA and is on track for a BLA submission in 2026 [6] - The company is advancing its del-desiran program for myotonic dystrophy type 1, with topline data from the Phase 3 HARBOR trial expected in the second half of 2026 [6] - Avidity is also progressing its del-brax program for facioscapulohumeral muscular dystrophy, with data readouts expected in 2026 [6]
Purpose In The Pressure: Catherine Dargan On Building Billion-Dollar Deals
Forbes· 2025-11-04 15:05
Core Insights - Catherine Dargan, a partner at Covington, is recognized for her leadership in multibillion-dollar mergers and acquisitions, particularly in the life sciences sector [1][2] - Dargan has built a premier M&A practice over 25 years, representing major clients like Merck and Novartis, and has led significant deals such as Novartis' $12 billion acquisition of Avidity Biosciences [2] - The M&A landscape is expected to remain active despite external challenges, with a focus on acquiring innovative products in medical, technology, and AI sectors [3] Company Overview - Covington's Corporate Practice, under Dargan's leadership, has a strong regulatory background that benefits its life sciences niche [2] - The firm emphasizes collaboration and expertise to help clients navigate risks in an uncertain economic environment [4] Industry Trends - There is tight competition for innovative products, prompting companies to pursue acquisitions proactively [3] - Dargan's role extends beyond legal counsel to being a trusted advisor for corporations considering megadeals [3][4]