Tandem Diabetes Stock Price, News & Analysis

Tandem Diabetes Care (NASDAQ: TNDM) announced that its t:slim X2 insulin pump with Control-IQ+ automated insulin delivery technology has received clearance for use with Lyumjev ultra-rapid acting insulin in the United States. The approval applies to people with type 1 diabetes ages 2 and above and all adults with type 2 diabetes.

The clearance was supported by a 13-week multicenter study involving 179 individuals, demonstrating high satisfaction and quality of life benefits. The t:slim X2 pump is now compatible with three insulin types: Humalog, Novolog, and Lyumjev U-100. Notably, Lyumjev is accessible through Lilly's Insulin Value Program at $35 monthly for those with commercial insurance or no insurance.

Tandem Diabetes Care (NASDAQ: TNDM) announced a significant study publication in Diabetes Care showing that their Control-IQ+ automated insulin delivery (AID) system benefits adults with type 2 diabetes regardless of their C-peptide levels. The sub-analysis of the 2IQP trial, involving 254 participants, demonstrated that patients using the t:slim X2 insulin pump with Control-IQ+ technology experienced a mean HbA1c decrease of 0.8% from baseline, significantly outperforming the control group.

The study challenges current Center for Medicare and Medicaid Services (CMS) criteria, which requires low C-peptide levels for insulin pump coverage. The research found equal benefits in both high C-peptide (N=195) and low C-peptide (N=59) groups, suggesting that C-peptide thresholds should not restrict access to AID therapy.

Tandem Diabetes Care (NASDAQ: TNDM) has received Health Canada authorization for its t:slim mobile application for both Android and iPhone platforms. The app enables users to deliver insulin boluses from their smartphones and upload pump data to the cloud-based Tandem Source platform.

The mobile app, expected to launch later in 2025, will display 24-hour glucose trends, pump status changes, insulin therapy data, and alerts when paired with a t:slim X2 insulin pump. Importantly, the t:slim X2 insulin pump operates independently from the app, ensuring users can always manage their therapy directly from the pump.

Tandem Diabetes Care (NASDAQ: TNDM) has issued a voluntary medical device correction for select t:slim X2 insulin pumps due to a critical speaker-related issue. The problem can trigger a Malfunction 16 alarm that stops insulin delivery and CGM communication, potentially leading to dangerous hyperglycemia.

The company has reported 700 confirmed adverse events and 59 reported injuries, with no deaths. Between July 22-24, 2025, affected U.S. customers received direct notifications. Tandem plans to release a software update to enhance early speaker failure detection and implement persistent vibration alerts to reduce safety risks.

Tandem Diabetes Care (NASDAQ: TNDM) reported its Q2 2025 financial results and updated full-year guidance. The company achieved record Q2 sales of $240.7 million, including $70.5 million from international markets. Q2 highlights include improved gross margins of 52% and pump shipments of 21,000 units in the U.S. and 9,000 internationally.

The company expects to reach a significant milestone of $1 billion in worldwide sales for 2025, with $700 million from U.S. sales and $300 million from international markets. However, TNDM reported a GAAP operating loss of $51.8 million (22% of sales) and adjusted its EBITDA margin guidance to negative 5% for the full year.

Notable developments include initiating an early access program for t:slim X2 with Control-IQ+ technology integrated with Abbott's FreeStyle Libre 3 Plus, receiving CE Mark for Tandem Mobi, and advancing pharmacy benefit initiatives for Q4 2025.

Tandem Diabetes Care (NASDAQ:TNDM), a leading insulin delivery and diabetes technology company, has announced its participation in three upcoming investor conferences in August and September 2025.

The company will present at the Canaccord Genuity Growth Conference on August 12 at 1:00 PM ET, the Morgan Stanley Global Healthcare Conference on September 10 at 9:15 AM ET, and will host meetings at the Bernstein Healthcare Forum on September 24. All presentations will be available via webcast on the company's investor relations website for 30 days.

Tandem Diabetes Care (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, has scheduled its second quarter 2025 financial results announcement for August 6, 2025 after market close.

The company will host a conference call and webcast at 4:30 PM Eastern Time on the same day to discuss the quarterly results. Investors can access the live webcast through Tandem's Investor Center website, with a recording available for 30 days afterward.

Tandem Diabetes Care (NASDAQ: TNDM) has announced compatibility between its t:slim X2 insulin pump with Control-IQ+ technology and Abbott's FreeStyle Libre 3 Plus sensor in the US. The integration enables automatic glucose readings every minute directly to the pump, with a 15-day sensor wear time. The Control-IQ+ technology adjusts insulin every 5 minutes based on predicted glucose values and features the unique AutoBolus feature for missed meal corrections. The company has launched an early access program and plans to expand availability in the second half of 2025. This integration aligns with American Diabetes Association recommendations for automated insulin delivery systems as the preferred method for type 1 and insulin-deficient diabetes management. The company plans to extend this compatibility to international markets later in the year.

Tandem Diabetes Care (NASDAQ: TNDM) has announced a strategic partnership with Abbott to develop and commercialize integrated diabetes management solutions. The collaboration will combine Abbott's upcoming dual glucose-ketone sensor with Tandem's insulin delivery systems. The innovative sensor under development will feature both glucose and ketone sensing capabilities, aimed at early detection of ketone rise to prevent diabetic ketoacidosis, a life-threatening condition. This integration represents a significant advancement in diabetes care technology, potentially enabling patients to make faster and more informed decisions about their health management.