Ongoing screening in CATT1 Phase 3 trial evaluating cadisegliatin in patients with type 1 diabetes (T1D) Topline Phase 3 data for cadisegliatin expected in 2H 2026 HIGH POINT, N.C., May 15, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes (T1D), today reported financial results for the first ...

Core Insights - Insulet Corporation has recently outperformed in the S&P 500, with its stock price rising over 24% in the past five days, driven by strong earnings and an upgraded financial outlook [2][4][8] Financial Performance - Insulet reported Q1 2025 total revenue of $569 million, a 28.8% year-over-year increase, exceeding analyst expectations of $543.20 million [4] - Adjusted earnings per share (EPS) for Q1 2025 were $1.02, surpassing the consensus estimate of $0.81 [4] - Total Omnipod revenue reached $554.1 million, reflecting a 28.0% year-over-year growth [5] - Gross margin improved by 240 basis points to 71.9%, with operating income at $88.8 million, or 15.6% of revenue [5] Guidance and Projections - Full-year 2025 revenue growth is now expected to be between 19%-22% in constant currency, with Omnipod revenue growth guidance raised to 20%-23% [6] - Gross margin guidance has been improved to 71% [6] Product Innovation and Market Strategy - The Omnipod 5 Automated Insulin Delivery system, featuring SmartAdjust™ technology, is central to Insulet's success, allowing for insulin adjustments every five minutes [7] - The company has expanded the Omnipod 5 to 14 countries, targeting both Type 1 and Type 2 diabetes patients, with its tubeless design as a key differentiator [7][8] Market Position and Future Outlook - Insulet's strong Q1 earnings and increased projections indicate effective market capture in the growing diabetes care sector [8] - The company's focus on innovation and global expansion positions it for long-term growth in the diabetes management market [8]

Summary of Sana Biotechnology Conference Call Company Overview - **Company**: Sana Biotechnology (SANA) - **Event**: 2025 Bank of America Healthcare Conference - **Date**: May 13, 2025 Key Points on Type One Diabetes - **Disease Impact**: Type one diabetes affects approximately nine million people globally, leading to a reduced lifespan of 10-15 years and significant daily challenges for patients [4][5] - **Unmet Medical Need**: No new drug has been developed for type one diabetes since insulin in 1923, indicating a substantial unmet need for better treatment options [5] - **Current Research**: Sana is focusing on gene-modified pluripotent stem cells to create a scalable source of pancreatic islets for transplantation, aiming to eliminate the need for immunosuppression [10][12] Recent Data and Developments - **Clinical Data**: A patient treated with gene-modified islet cells has been insulin-free for over 30 years, with no signs of immunologic response after 12 weeks [10][12] - **Future Plans**: An Investigational New Drug (IND) application is anticipated next year, with the goal of beginning human treatments [11][12] Challenges and Considerations - **Scaling Production**: Significant work is required to scale the production of gene-modified islets to meet the needs of the nine million affected individuals [18][20] - **Manufacturing Process**: The manufacturing process must be locked in before starting pivotal studies, which is expected to take about a year [29] Other Pipeline Assets - **CAR T Cell Therapy**: Sana is applying hypoimmune technology to develop allogeneic CAR T cells, addressing challenges in the autoimmune setting and aiming for improved patient convenience [31][32] - **Ongoing Studies**: Two studies, Gleam and Vivid, are ongoing, with data expected later this year [30] Market and Financial Considerations - **Investment Landscape**: The company acknowledges the need for increased investment to continue development, particularly in the competitive field of cell and gene therapy [39][40] - **Return on Investment**: The potential for high ROI is emphasized, contingent on successful scaling and safety of the diabetes treatment [43][44] Regulatory Environment - **FDA Interactions**: The company is optimistic about upcoming meetings with the FDA to confirm testing protocols for their gene-modified therapies [17] Conclusion - **Commitment to Diabetes Asset**: Sana Biotechnology is committed to advancing its diabetes treatment while navigating the complexities of scaling production and ensuring safety [42]

Senseonics (SENS) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Company Participants Jeremy Feffer - Managing DirectorTimothy Goodnow - President & Chief Executive OfficerRick Sullivan - CFOAnthony Petrone - Managing Director Equity Research Conference Call Participants Sam Eiber - Vice President and Medical Technology Analyst Operator Please stand by. Your program is about to begin. Good day, everyone, and welcome to the Senseonics First Quarter twenty twenty five Earnings Call. At this time, all particip ...

7 May 2025 - Financial report for the period 1 January 2025 to 31 March 2025 Operating profit increased by 22% in Danish kroner and by 20% at constant exchange rates (CER) to DKK 38.8 billion.Sales in US Operations increased by 20% in Danish kroner (17% at CER). Sales in International Operations increased by 18% in Danish kroner (19% at CER).Sales within Diabetes and Obesity care increased by 21% in Danish kroner to DKK 73.5 billion (19% at CER), mainly driven by Obesity care growth of 67% in Danish kron ...

Data suggest BP1001-A prevents fatty acid-induced insulin resistance in cellsHOUSTON, May 01, 2025 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (OTCQB:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer and obesity drugs, today reported the achievement of a third milestone from recent preclinical studies of BP1001-A that provide additional support for its potential as a treatment for obesity. ...

Novo Nordisk (NVO) is expected to beat estimates when it reports its first-quarter 2025 results before the opening bell on May 7, 2025. The Zacks Consensus Estimate for quarterly revenues in the to-be-reported quarter is pegged at $11.33 billion, while the same for earnings is pinned at 91 cents per share. (See the Zacks Earnings Calendar to stay ahead of market-making news.)In the past 30 days, the Zacks Consensus Estimate for Novo Nordisk’s 2025 earnings per share (EPS) declined from $3.88 to $3.81. Durin ...

Core Insights - Medtronic has received FDA approval for the Simplera Sync™ sensor, enhancing the MiniMed™ 780G system's capabilities in the U.S. market [1][3] - The Simplera Sync™ sensor is a disposable, all-in-one device that eliminates the need for fingersticks and simplifies the insertion process, providing greater flexibility for users [2][6] - The MiniMed™ 780G system features an adaptive algorithm that adjusts glucose levels every 5 minutes, utilizing Meal Detection™ technology to optimize insulin delivery [2][3] Product Features - The Simplera Sync™ sensor is designed to work seamlessly with the MiniMed™ 780G system, which can now utilize both the Guardian™ 4 sensor and the new Simplera Sync™ sensor [1][3] - The system allows for flexible glucose targets as low as 100 mg/dL and has shown real-world data indicating users achieve over 70% time in range when using optimal settings [2][6] - The MiniMed™ 780G system is the only one that can be paired with an infusion set lasting up to 7 days, significantly reducing the frequency of injections [2][6] Company Commitment - Medtronic is dedicated to innovating diabetes management technologies to improve the quality of life for individuals living with diabetes [3][4] - The company plans a limited launch of the Simplera Sync™ sensor in the U.S. in fall 2025, further expanding its CGM options [3][4] - Medtronic has a long history of pioneering diabetes technology and aims to continue leading in this field through advanced sensors and intelligent dosing systems [4][5]

The U.S. Food and Drug Administration approved DexCom, Inc.’s DXCM Dexcom G7 15-Day Continuous Glucose Monitoring System for people over 18 with diabetes.With an overall Mean Absolute Relative Difference (MARD) of 8.0%, Dexcom G7 15 Day builds on the performance of Dexcom CGM, which is clinically proven to lower A1C, reduce hyper- and hypoglycemia, and increase time in range.Also Read: Trump Tariffs Spare Drugmakers But Threaten Diabetes Device IndustryNew with Dexcom G7 15 DayLongest lasting CGM system wit ...

Core Viewpoint - Vertex Pharmaceuticals is advancing its investigational candidates for type 1 diabetes, specifically zimislecel and VX-264, with significant updates on their development status [1][4][6]. Group 1: Zimislecel Development - Zimislecel is in pivotal late-stage development for treating patients with type 1 diabetes who experience severe hypoglycemic events and impaired awareness of hypoglycemia [2][4]. - The company plans to complete enrollment and dosing in the ongoing phase I/II/III study by the first half of 2025, with regulatory filings for approval expected in 2026 [4]. - Initial approval for zimislecel could potentially benefit around 60,000 patients globally suffering from severe type 1 diabetes [5]. Group 2: VX-264 Development - VX-264 was being evaluated in a phase I/II study, but Vertex has decided to halt further development due to failure to meet efficacy endpoints, specifically not showing meaningful increases in C-peptide levels [6][8]. - The study's primary endpoints included safety and changes in peak C-peptide during a mixed-meal tolerance test, which did not yield the required results [6][8]. Group 3: Stock Performance - Year to date, Vertex shares have increased by 20.4%, significantly outperforming the industry average rise of 3.5% [3].