FDA expedites review of Sanofi’s Tzield for type 1 diabetes treatment

PARIS - The U.S. Food and Drug Administration has accepted Sanofi’s supplemental biologics license application for Tzield for expedited review under the Commissioner’s National Priority Voucher pilot program, potentially shortening the review process from 10-12 months to just 1-2 months. The news comes as Sanofi, with a market capitalization of $144.7 billion, continues to demonstrate strong market performance, with its stock up nearly 117% year-to-date according to InvestingPro data.

The application seeks approval for Tzield (teplizumab-mzwv) to delay the progression of stage 3 type 1 diabetes in adults and pediatric patients eight years and older who have been recently diagnosed with the condition.

The FDA selected Tzield for the expedited review program based on its potential to address a significant unmet medical need. If approved, Tzield would become the first disease-modifying therapy for this indication. With a P/E ratio of 10.27 and strong financial health metrics, Sanofi appears well-positioned to capitalize on this opportunity. InvestingPro analysis suggests the stock is currently trading below its Fair Value, making it potentially attractive for investors interested in healthcare innovation. Get access to 10 more exclusive ProTips and comprehensive analysis with an InvestingPro subscription.

The application is supported by results from the PROTECT phase 3 study, which met its primary endpoint of preserving beta cell function, as measured by significantly slowing the decrease in mean C-peptide levels compared to placebo.

"This is a recognition of the breakthrough innovative profile of Tzield, its ability to potentially prevent the natural progression of T1D, and the significant unmet medical need that remains in this area which has seen limited treatment advances in the last 100 years," said Olivier Charmeil, Executive Vice President of General Medicines at Sanofi.

The most common adverse events reported in the study were headache, nausea, rash, lymphopenia, leukopenia and gastrointestinal symptoms. According to the press release, 1.8% of patients who received Tzield developed cytokine release syndrome possibly or probably related to the treatment.

Tzield is currently approved in several countries, including the U.S., UK, China, and Canada, to delay the onset of stage 3 type 1 diabetes in patients diagnosed with stage 2 of the disease. Regulatory reviews are ongoing in the European Union and other jurisdictions worldwide.

The application is also being reviewed under the FDA’s accelerated approval program, which allows for faster review of therapies addressing serious conditions with unmet medical needs.

In other recent news, Banco Santander reported its second-quarter earnings for 2025, achieving a record first-half performance with a profit of €3.4 billion. Despite this achievement, the bank’s earnings per share of $0.2535 fell slightly below analysts’ expectations of $0.2569. Additionally, revenue for the quarter was $17.83 billion, which did not meet the anticipated $18.21 billion. In another development, Goldman Sachs reiterated its Buy rating on Banco Santander, setting a price target of EUR10.40. The investment bank maintains a positive outlook on Santander, citing expected benefits from economic growth in key markets. These recent developments highlight the ongoing interest and analysis from financial institutions regarding Banco Santander’s performance and future prospects.

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