FDA Accepts SNY Filing for Expanded Use of T1D Drug in Young Children

Sanofi SNY announced that the FDA has accepted a regulatory filing seeking to expand the use of its type 1 diabetes (T1D) drug, Tzield (teplizumab), in individuals aged one year and older. The agency has granted priority review to this filing, with a final decision expected by April 29, 2026.

If approved, Tzield will be the first disease-modifying therapy to delay the onset of stage 3 T1D in children aged one year and older with stage 2 disease. The drug is currently approved for use in the same indication across patients aged eight years and older.

Patients suffering from stage 3 T1D eventually require constant monitoring and insulin injections for life. This stage is marked by the destruction of a significant portion of the beta cells and reaching the point of clinical hyperglycaemia (high blood sugar).

The regulatory filing is supported by positive interim data from the ongoing phase IV PETITE-T1D study, which is evaluating Tzield in children under eight years diagnosed with stage 2 T1D.

SNY’s Stock Performance

In the past year, shares of Sanofi have declined 2% against the industry’s 19% growth.

More on SNY’s Tzield

Tzield was added to Sanofi’s portfolio in 2023 after it acquired Provention Bio for $2.9 billion. The drug was originally developed by MacroGenics MGNX. Provention Bio had acquired this drug from MacroGenics under an asset purchase agreement signed in 2018.

A regulatory filing for the drug is also under review in the European Union, seeking approval to delay the onset of stage 3 T1D in patients aged eight and older diagnosed with stage 2 of the disease. If approved, Sanofi will market the drug in the region under the brand name Teizeild. A regulatory decision is expected soon.

SNY’s Zacks Rank

Sanofi currently carries a Zacks Rank #3 (Hold).

Sanofi Price

 

Sanofi price | Sanofi Quote

Key Picks Among Biotech Stocks

Some better-ranked stocks from the sector are ANI Pharmaceuticals ANIP and CorMedix CRMD, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $7.29 to $7.56. EPS estimates for 2026 have increased from $7.81 to $8.08 during the same period. In the past year, shares of ANIP have surged nearly 44%.

ANIP’s earnings beat estimates in the trailing four quarters, delivering an average surprise of 21.24%.

Estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87 over the past 60 days, while the same for 2026 has increased from $2.49 to $2.88. CRMD shares have risen 53% in the past year.

CorMedix’s earnings beat estimates in the trailing four quarters, delivering an average surprise of 27.04%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research