Tandem Diabetes Care reported significant regulatory news on Thursday, which led to a notable increase in its stock price. By the end of the trading day, the company’s shares had surged by over 4%, outperforming the 1.7% rise of the S&P 500 index.
The company announced that it had received approval from the European Medicines Agency (EMA) under the European Union (EU) framework. This approval allows Tandem’s t:slim X2 automated insulin delivery (AID) pump to be used for administering Eli Lilly’s ultra-rapid acting insulin product, Lyumjev. Lyumjev itself was approved in the EU back in 2020, but Tandem needed additional time to complete the stringent testing required by the EU for pump manufacturers. Eli Lilly and Tandem collaborated to conduct tests ensuring the compatibility of Lyumjev with the t:slim X2 delivery system.
In a press release, Jordan Pinsker, the Chief Medical Officer of Tandem, highlighted the benefits of rapid-acting insulin, stating, “Ultra-rapid-acting insulin is a popular choice for people living with diabetes due to its fast response time. We are proud to be able to offer Lyumjev compatibility with our t:slim X2 pump as part of an AID system in the EU, providing more flexibility for our customers in these countries.”
Approval in a large and diverse jurisdiction like the EU represents a significant milestone for any healthcare company. Building on this success, Tandem and Eli Lilly intend to seek approvals for Lyumjev compatibility with Tandem’s delivery systems in additional markets worldwide.
Eric Volkman, the author, disclosed that he holds no positions in the mentioned stocks, and The Motley Fool also indicated no positions in the mentioned stocks, maintaining a policy of transparency and disclosure.
