Tandem Diabetes stock rises on FDA clearance

Investing.com -- Shares of Tandem Diabetes Care, Inc. (NASDAQ:TNDM) climbed 7% following the FDA clearance of its Control-IQ+ technology for use in adults with type 2 diabetes. The approval marks an expansion of the company’s automated insulin delivery (AID) solutions, previously available for type 1 diabetes patients, and is anticipated to be accessible to U.S. customers in March 2025.

Tandem Diabetes announced the FDA’s authorization of Control-IQ+, an enhancement of their established Control-IQ algorithm, designed to accommodate a broader range of user inputs. The decision was backed by results from a pivotal trial involving over 300 participants, comparing the efficacy of the t:slim X2 pump with Control-IQ+ technology against a control group using multiple daily injections. Complete findings from the study will be presented at the International Conference on Advanced Technologies & Treatments for Diabetes in Amsterdam in March 2025.

John Sheridan, Tandem’s president and CEO, expressed confidence in the technology’s ability to improve health outcomes, citing its success with type 1 diabetes patients. The company’s t:slim X2 and Tandem Mobi systems, powered by Control-IQ technology, have demonstrated significant glycemic improvements in several studies.

Canaccord Genuity analyst William Plovanic commented on the development, highlighting the competitive advantage Tandem holds despite being approximately six months behind Insulet (NASDAQ:PODD) in obtaining the type 2 diabetes indication. Plovanic noted that with Medtronic (NYSE:MDT) not expected to receive FDA clearance until late 2025 or later, the situation effectively becomes a two-horse race. He emphasized the importance of the clearance as a "major multi-year catalyst for Tandem and the pump industry," given the substantial revenue potential it represents. Plovanic said, "We believe this is a major multi-year catalyst for Tandem and the pump industry given the significant incremental revenue opportunity."

Tandem is set to report its fourth-quarter earnings on February 26, 2025, after market close. The recent FDA clearance and upcoming presentation of the full study results are expected to remain focal points for investors and industry observers alike.

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