Abbott Gains FDA Approval for Tendyne™, Strengthening Its Minimally Invasive Heart Portfolio
Abbott Laboratories (NYSE:ABT) has received FDA approval today for its Tendyne™ transcatheter mitral valve replacement (TMVR) system, the first device of its kind approved in the US to treat mitral valve disease without open-heart surgery.
Tendyne is specifically designed for patients who are not suitable candidates for surgical valve repair or replacement. The product perfectly fits the aging population trends and the demand for less invasive treatments, implying that it could become a significant cash cow for ABT.
An operating room with a doctor monitoring a patient's vital signs during surgery with a medical device.
The approval gives Abbott Laboratories (NYSE:ABT) a competitive edge in the growing structural heart market, valued at around $15 billion globally, and will likely accelerate the company's growth. The Medical Devices segment accounts for 47% of total revenue in Q1 2025 and is the fastest growing segment - the US revenues posted 15% growth YoY, meaning that the segment is already central to the growth story.
The announcement comes weeks after ABT reiterated its organic revenue growth guidance at 7.5% to 8.5% for FY2025, while the street consensus expects only 6.4% total revenue growth. This raises the odds of positive surprises later in the year, which could propel ABT shares even higher. For reference, ABT already outperforms the broad market by a massive 17% year-to-date, highlighting its strong momentum.
Abbott Laboratories (NYSE:ABT) is a global healthcare company that owns a portfolio of life-changing technologies across diagnostics, medical devices, nutritionals, and branded generic medicines.
While we acknowledge the potential of ABT as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than ABT and that has 100x upside potential, check out our report about this cheapest AI stock.
READ NEXT: and
Disclosure: None.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Insider
21 minutes ago
- Business Insider
Bank of America Securities Keeps Their Hold Rating on Nio (NIO)
Bank of America Securities analyst Ming-Hsun Lee maintained a Hold rating on Nio (NIO – Research Report) today and set a price target of $4.30. The company's shares closed today at $3.53. Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter According to TipRanks, Lee is a 4-star analyst with an average return of 19.9% and a 40.45% success rate. Lee covers the Consumer Cyclical sector, focusing on stocks such as Nio, Li Auto, and XPeng, Inc. ADR. In addition to Bank of America Securities, Nio also received a Hold from Mizuho Securities's Vijay Rakesh in a report issued today. However, on the same day, Morgan Stanley reiterated a Buy rating on Nio (NYSE: NIO). The company has a one-year high of $7.71 and a one-year low of $3.02. Currently, Nio has an average volume of 49.41M.
Yahoo
23 minutes ago
- Yahoo
Ascletis Announces Phase III Trial of Denifanstat (ASC40), a First-in-Class, Once-Daily Oral FASN Inhibitor for Acne, Meets All Endpoints
Denifanstat (ASC40), a once-daily oral fatty acid synthase (FASN) inhibitor, demonstrated statistically significant and clinically meaningful improvement compared to placebo in all primary, key secondary, and secondary endpoints Denifanstat demonstrated a favorable safety and tolerability profile Denifanstat was 98% and 178% more effective than U.S. Food and Drug Administration (FDA)-approved sarecycline and doxycycline with regard to placebo-adjusted percent treatment success, respectively, 18.6% for denifanstat versus 9.4% for sarecycline, 18.6% versus 6.7% for doxycycline Denifanstat was 60% more effective than FDA-approved clascoterone cream with regard to placebo-adjusted percent treatment success, 18.6% for denifanstat versus 11.6% for clascoterone cream, respectively The exceptional efficacy of denifanstat coupled with its favorable safety profile in the Phase III trial provides a potential major break-through for the treatment of acne HONG KONG, June 3, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor, meets all primary, key secondary, and secondary endpoints in the Phase III clinical trial for the treatment of moderate to severe acne vulgaris (NCT06192264). The Phase III clinical trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of denifanstat once-daily oral tablet in 480 patients with moderate to severe acne vulgaris. Patients were enrolled and randomized into one active treatment arm and one placebo control arm at the ratio of 1:1 to receive 50 mg denifanstat oral tablet once daily or matching placebo for 12 weeks. Baseline characteristics were well balanced between denifanstat and placebo arms. Table 1 summarizes some of baseline characteristics. Primary, key secondary, and secondary endpoints can be found in Table 2. Primary endpoints included the percent treatment success (defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease in IGA from baseline at week 12), the percent reduction from baseline in total lesion count, and the percent reduction from baseline in inflammatory lesion count. At week 12, percent treatment success was 33.2% compared to 14.6% for placebo, p<0.0001, percent reduction from baseline in total lesion count was 57.4% compared to 35.4% for placebo, p<0.0001, and percent reduction from baseline in inflammatory lesion count was 63.5% compared to 43.2% for placebo, p<0.0001. The key secondary endpoint, percent reduction from baseline in non-inflammatory lesion count at week 12, was 51.9% compared to 28.9% for placebo, p<0.0001. Denifanstat demonstrated a favorable safety and tolerability profile following 12 weeks of once-daily oral administration at 50 mg. The incidence rates of treatment-emergent adverse events (TEAEs) were comparable between denifanstat and placebo. No incidence rates of TEAEs related to study drug in any category exceeded 10%. Only two categories of TEAEs had an incidence rate of more than 5% (6.3% dry skin in denifanstat-treated patients versus 2.9% in the placebo group; 5.9% dry eye in denifanstat-treated patients versus 3.8% in the placebo group). All denifanstat-related adverse events (AEs) were mild or moderate. There were no denifanstat-related grade 3 or 4 AEs and no denifanstat-related serious AEs (SAEs). No deaths were reported. The mechanisms of action of denifanstat for the treatment of acne are (1) direct inhibition of facial sebum production, through inhibition of de novo lipogenesis (DNL) in human sebocytes; and (2) inhibition of inflammation, through decreasing cytokine secretion and Th17 differentiation. Denifanstat's unique mechanism of action directly reduces one of the main underlying causes of acne which is the overproduction of sebum. This makes denifanstat unique as most other acne treatments do not treat the underlying cause of the condition. "We are extremely pleased with the topline results of our Phase III trial. Denifanstat tablets demonstrated impressive efficacy beyond treatment success, showing significant reductions in total lesion count, inflammatory lesion count, and non-inflammatory lesion count. We are excited to be submitting this innovative treatment with the China National Medical Products Administration (NMPA) soon." said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis. Table 3 highlights the excellent efficacy of denifanstat in a non-head-to-head comparison to other commonly used oral and topical acne treatments. Denifanstat demonstrated its exceptional efficacy across multiple key metrics compared to sarecycline, doxycycline and clascoterone cream. With regard to the placebo-adjusted percent treatment success and the placebo-adjusted percent reduction from baseline in inflammatory lesion count, denifanstat was 98% and 30% more effective than sarecycline, respectively, 178% and 178% more effective than doxycycline, respectively, and 60% and 59% more effective than clascoterone cream, respectively. With regard to the placebo-adjusted percent reduction from baseline in total lesion count, denifanstat was 189% and 85% more effective than doxycycline and clascoterone cream, respectively. With regard to the placebo-adjusted percent reduction from baseline in non-inflammatory lesion count, denifanstat was 411% and 102% more effective than sarecycline and clascoterone cream, respectively. Denifanstat has the potential to be a first-in-class, once-daily, oral acne therapeutic, potentially offering both exceptional efficacy and patient compliance with a favorable safety and tolerability profile. Compared to other oral acne treatments, denifanstat provides outstanding efficacy with excellent safety. There is no potential for antibiotic resistance or off target effects which can occur with tetracycline derivatives and no reported denifanstat-related severe AEs such as hepatotoxicity, hearing impairment and depression which are seen with isotretinoin. Denifanstat should also provide better adherence to treatment compared to topical therapies: an estimated 30% to 40% of patients do not adhere to their topical treatments[1]. Denifanstat is licensed from Sagimet Biosciences Inc. (Nasdaq: SGMT) for exclusive rights in Greater China. "The Phase III clinical trial results for denifanstat are highly encouraging. The data demonstrate statistically significant improvements in treatment outcomes for moderate-to-severe acne patients, with percent treatment success of 33.2%, total lesion count reduction of 57.4% from baseline, inflammatory and non-inflammatory lesion counts decreasing by 63.5% and 51.9%, respectively, while maintaining a favorable safety and tolerability profile. Denifanstat's first-in-class mechanism targeting FASN directly addresses a key cause for acne, establishing it as a groundbreaking therapeutic approach in acne treatment." said Prof. Leihong Xiang, Chief Physician of Dermatological Department, Huashan Hospital, Fudan University, Executive Deputy Director of Institute of Dermatology, Fudan University, Deputy Director of Dermatology Division of Chinese Medical Doctor Association and principal investigator of denifanstat Phase III trial for moderate to severe acne. [1] Purvis CG, Balogh EA, Feldman SR. Clascoterone: How the Novel Androgen Receptor Inhibitor Fits Into the Acne Treatment Paradigm. Ann Pharmacother. 2021;55(10):1297-1299. doi:10.1177/1060028021992055. Table 1. Baseline characteristics of Phase III trial of denifanstat Baseline characteristics 50 mg denifanstat, oral, oncedaily (n=240) Placebo, oral, once daily (n=240) Total lesion count 102.2 102.1 Inflammatory lesion count 42.1 43.1 IGA=3 (moderate), % 85.8 85.8 IGA=4 (severe), % 14.2 14.2 Table 2. Efficacy endpoints of 50 mg denifanstat oral, once daily at week 12 versus placebo (intent-to-treat, ITT, analysis) Efficacy endpoints (1) 50 mg denifanstat, oral, once daily (n=240) Placebo, oral,once daily (n=240) Placebo adjusted p value Percent treatment success (2) (primary endpoint) 33.2 14.6 18.6 <0.0001 Percent reduction from baseline in total lesion count (primary endpoint) 57.4 35.4 22.0 <0.0001 Percent reduction from baseline ininflammatory lesion count (primary endpoint) 63.5 43.2 20.3 <0.0001 Percent reduction from baseline in non-inflammatory lesion count (key secondary endpoint) 51.9 28.9 23.0 <0.0001 Absolute reduction from baseline intotal lesion count (secondary endpoint) 58.3 36.2 22.1 <0.0001 Absolute reduction from baseline in inflammatory lesion count (secondaryendpoint) 26.6 18.4 8.2 <0.0001 Notes: (1) All efficacy endpoints are least square means.(2) Treatment success is defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease in IGA from baseline at week 12. Table 3. Denifanstat compared to other commonly used acne treatments (not head-to-head comparison) Category Denifanstat (n=240) Sarecycline(1) (n=1002) Doxycycline(2) (n=216) Clascoterone cream(3) (n=722) Baseline characteristics Total lesion count 102.2 72.4 71.7 103.6 Inflammatory lesion count 42.1 30.0 33.6 42.7 IGA=3 (moderate), % 85.8 85.2 93.5 82.7 IGA=4 (severe), % 14.2 14.9 6.5 17.3 Efficacy endpoints at week 12 Placebo-adjusted percenttreatment success 18.6 9.4 6.7 11.6 Placebo-adjusted percent reductionfrom baseline in total lesion count 22.0 NA 7.6 11.9 Placebo-adjusted percent reductionfrom baseline in inflammatorylesion count 20.3 15.6 7.3 12.8 Placebo-adjusted percent reduction from baseline in non-inflammatorylesion count 23.0 4.5 NA 11.4 Notes: (1) The sarecycline data represent an analysis of its two Phase III clinical trials, with values expressed as means. The data are from Moore, A., et al., J Drugs Dermatol 2018 Vol. 17 Issue 9 Pages 987-996. The non- inflammatory lesion count data are from FDA ( The doxycycline data at week 16 are from Moore, A., et al., J Drugs Dermatol 2015 Vol. 14 Issue 6 Pages 581-6.(3) The clascoterone cream (1%) data represent an analysis of its two Phase III clinical trials, with values expressed as means. The data are from Hebert. A, et al., JAMA Dermatology 2020 Vol. 156 Issue 6, DOI: 10.1001/jamadermatol.2020.0465. About Ascletis Pharma Inc. Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange ( covering the entire value chain from discovery and development to GMP manufacturing. Led by a management team with deep expertise and a proven track record, Ascletis is focused on metabolic diseases by addressing unmet medical needs from a global perspective. Ascletis has multiple clinical stage drug candidates in its metabolic disease pipeline. For more information, please visit Contact: Peter VozzoICR Healthcare443-231-0505 (U.S.) Ascletis Pharma Inc. PR and IR teams+86-181-0650-9129 (China)pr@ ir@ View original content: SOURCE Ascletis Pharma Inc. Sign in to access your portfolio
Yahoo
29 minutes ago
- Yahoo
3 Growth Companies With High Insider Ownership And Up To 37% Revenue Growth
The market has climbed by 2.0% over the past week, with every sector up, contributing to a 12% increase over the last 12 months. In this context of overall growth and an optimistic forecast for earnings to grow by 14% annually, companies that exhibit both substantial revenue growth and high insider ownership can be particularly appealing for investors seeking alignment between management interests and shareholder value. Name Insider Ownership Earnings Growth Atour Lifestyle Holdings (NasdaqGS:ATAT) 22.7% 24.1% Super Micro Computer (NasdaqGS:SMCI) 16.2% 39.1% Duolingo (NasdaqGS:DUOL) 14.3% 39.9% FTC Solar (NasdaqCM:FTCI) 27.9% 62.5% Credo Technology Group Holding (NasdaqGS:CRDO) 12.1% 65.1% Astera Labs (NasdaqGS:ALAB) 15.1% 44.4% Enovix (NasdaqGS:ENVX) 12.1% 58.4% BBB Foods (NYSE:TBBB) 12.9% 30.2% OS Therapies (NYSEAM:OSTX) 23.2% 67.2% Zapp Electric Vehicles Group (OTCPK:ZAPP.F) 16.1% 120.2% Click here to see the full list of 191 stocks from our Fast Growing US Companies With High Insider Ownership screener. Here's a peek at a few of the choices from the screener. Simply Wall St Growth Rating: ★★★★★☆ Overview: Applied Digital Corporation designs, develops, and operates digital infrastructure solutions and cloud services for high-performance computing and artificial intelligence industries in North America, with a market cap of approximately $1.53 billion. Operations: The company's revenue is derived from two main segments: Cloud Services, contributing $88.11 million, and Datacenter Hosting, generating $133.08 million. Insider Ownership: 10% Revenue Growth Forecast: 37.4% p.a. Applied Digital is poised for significant growth with its revenue forecast to increase by 37.4% annually, outpacing the US market. The company recently secured two 15-year lease agreements with CoreWeave, projected to generate approximately US$7 billion in revenue. Despite past shareholder dilution and a volatile share price, Applied Digital's strategic positioning in AI and HPC infrastructure development at its Ellendale campus highlights its potential as an emerging leader in the data center ecosystem. Click here and access our complete growth analysis report to understand the dynamics of Applied Digital. The valuation report we've compiled suggests that Applied Digital's current price could be inflated. Simply Wall St Growth Rating: ★★★★★★ Overview: Super Micro Computer, Inc. develops and sells high-performance server and storage solutions based on modular and open architecture across the United States, Europe, Asia, and internationally, with a market cap of approximately $23.88 billion. Operations: The company generates revenue of $21.57 billion from developing and providing high-performance server solutions based on modular and open architecture across various regions including the United States, Europe, and Asia. Insider Ownership: 16.2% Revenue Growth Forecast: 26.4% p.a. Super Micro Computer is positioned for robust growth, with earnings expected to rise significantly at 39.1% annually, surpassing the US market's average. Recent strategic partnerships, including collaborations with Digi Power X and DataVolt, highlight its expansion in AI and data center solutions. Despite a volatile share price and reduced profit margins compared to last year, Supermicro's revenue is forecast to grow rapidly at 26.4% per year, reflecting its strong market potential in high-performance computing infrastructure. Navigate through the intricacies of Super Micro Computer with our comprehensive analyst estimates report here. According our valuation report, there's an indication that Super Micro Computer's share price might be on the cheaper side. Simply Wall St Growth Rating: ★★★★★☆ Overview: Ryan Specialty Holdings, Inc. provides specialty products and solutions for insurance brokers, agents, and carriers across multiple regions including the United States, Canada, the United Kingdom, Europe, India, and Singapore with a market cap of $18.78 billion. Operations: Ryan Specialty Holdings generates $2.59 billion in revenue from its insurance brokers segment. Insider Ownership: 15.5% Revenue Growth Forecast: 16.7% p.a. Ryan Specialty Holdings is poised for substantial growth, with earnings projected to increase significantly at 91% annually, outpacing the US market. Despite a recent net loss of US$4.39 million in Q1 2025, revenue grew to US$690.17 million from the previous year. The company maintains its organic revenue growth outlook between 11-13% for 2025 and continues exploring M&A opportunities despite high leverage levels, supported by strong free cash flow and balance sheet flexibility. Get an in-depth perspective on Ryan Specialty Holdings' performance by reading our analyst estimates report here. Our expertly prepared valuation report Ryan Specialty Holdings implies its share price may be too high. Discover the full array of 191 Fast Growing US Companies With High Insider Ownership right here. Ready To Venture Into Other Investment Styles? Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. 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 analysis only considers stock directly held by insiders. It does not include indirectly owned stock through other vehicles such as corporate and/or trust entities. All forecast revenue and earnings growth rates quoted are in terms of annualised (per annum) growth rates over 1-3 years. Companies discussed in this article include NasdaqGS:APLD NasdaqGS:SMCI and NYSE:RYAN. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@
