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Sanofi Wins FDA Nod for Expanded Use of T1D Drug in Children
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Key Takeaways
Sanofi's Tzield gained FDA accelerated approval for children 8-17 with newly diagnosed stage 3 T1D.
Tzield slowed C-peptide decline in phase III PROTECT, a marker of insulin production.
Sanofi is enrolling the confirmatory late-stage BETA-PRESERVE study to support full approval.
Sanofi (SNY - Free Report) announced that the FDA has approved its type I diabetes (T1D) drug, Tzield (teplizumab), for a new indication under the accelerated pathway. The agency has cleared the therapy to delay the loss of the body’s own insulin production for pediatric patients aged eight to 17 years who were recently diagnosed with Stage 3 T1D.
Per the company, the latest approval makes Tzield the first disease-modifying therapy for this patient population. The drug is already approved to delay the onset of stage 3 T1D in children aged one year and older with stage 2 disease.
The FDA’s decision is supported by positive results from the phase III PROTECT study, which showed that treatment with the drug slowed the decline in C-peptide levels, an indicator of how much insulin the body is still producing. Sanofi is currently enrolling patients in the late-stage BETA-PRESERVE study, which will serve as a confirmatory study required for full approval.
SNY’s Stock Performance
Year to date, shares of the company have declined nearly 9% against the industry’s 5% growth.
Image Source: Zacks Investment Research
How Sanofi Benefits From Tzield’s Label Expansion?
The latest label expansion broadens the drug's addressable market by allowing Sanofi to treat children who have already progressed to stage 3 T1D following diagnosis.
While stage 2 T1D can be identified through proactive screening before symptoms emerge, widespread screening remains uncommon because patients are typically asymptomatic at this stage. In contrast, many patients are diagnosed only after progressing to stage 3 and developing clinical symptoms, potentially making the newly approved patient population easier to identify and treat.
Patients with stage 3 T1D eventually require constant monitoring and insulin injections for life. This stage is marked by the destruction of a significant portion of insulin-producing beta cells and reaching the point of clinical hyperglycaemia (high blood sugar).
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 - Free Report) . Provention Bio had acquired this drug from MacroGenics under an asset purchase agreement signed in 2018.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents. Over the same period, estimates for 2027 EPS have risen from 24 cents to 87 cents. IMCR’s shares have lost nearly 17% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 46.66%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen from $3.66 to $4.27. INDV’s shares are up more than 7% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.
View the Zacks #1 Rank List
Image: Bigstock
Sanofi Wins FDA Nod for Expanded Use of T1D Drug in Children
Key Takeaways
Sanofi (SNY - Free Report) announced that the FDA has approved its type I diabetes (T1D) drug, Tzield (teplizumab), for a new indication under the accelerated pathway. The agency has cleared the therapy to delay the loss of the body’s own insulin production for pediatric patients aged eight to 17 years who were recently diagnosed with Stage 3 T1D.
Per the company, the latest approval makes Tzield the first disease-modifying therapy for this patient population. The drug is already approved to delay the onset of stage 3 T1D in children aged one year and older with stage 2 disease.
The FDA’s decision is supported by positive results from the phase III PROTECT study, which showed that treatment with the drug slowed the decline in C-peptide levels, an indicator of how much insulin the body is still producing. Sanofi is currently enrolling patients in the late-stage BETA-PRESERVE study, which will serve as a confirmatory study required for full approval.
SNY’s Stock Performance
Year to date, shares of the company have declined nearly 9% against the industry’s 5% growth.
Image Source: Zacks Investment Research
How Sanofi Benefits From Tzield’s Label Expansion?
The latest label expansion broadens the drug's addressable market by allowing Sanofi to treat children who have already progressed to stage 3 T1D following diagnosis.
While stage 2 T1D can be identified through proactive screening before symptoms emerge, widespread screening remains uncommon because patients are typically asymptomatic at this stage. In contrast, many patients are diagnosed only after progressing to stage 3 and developing clinical symptoms, potentially making the newly approved patient population easier to identify and treat.
Patients with stage 3 T1D eventually require constant monitoring and insulin injections for life. This stage is marked by the destruction of a significant portion of insulin-producing beta cells and reaching the point of clinical hyperglycaemia (high blood sugar).
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 - Free Report) . Provention Bio had acquired this drug from MacroGenics under an asset purchase agreement signed in 2018.
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 Immunocore (IMCR - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents. Over the same period, estimates for 2027 EPS have risen from 24 cents to 87 cents. IMCR’s shares have lost nearly 17% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 46.66%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen from $3.66 to $4.27. INDV’s shares are up more than 7% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.