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SNY's Tzield Gets FDA Nod for Kids, Sarclisa SC BLA Faces Delay
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Key Takeaways
Sanofi gains FDA approval to expand Tzield use to children aged one and older with stage 2 T1D.
SNY's Sarclisa SC review is delayed by the FDA, with the new action date set on July 23, 2026.
Sarclisa SC aims to offer first on-body injector delivery if approved across MM indications.
Sanofi (SNY - Free Report) announced that the FDA has approved the supplemental biologic license application (sBLA) seeking to expand the use of Tzield (teplizumab) to delay the onset of stage 3 T1D in individuals aged one year and older with stage 2 disease.
Separately, the FDA has extended the review timeline for the BLA seeking approval for a subcutaneous (SC) formulation of its cancer drug, Sarclisa, for treating multiple myeloma (MM) by up to three months.
Regulatory Update on SNY’s Sarclisa SC
The BLA seeks approval for the use of Sarclisa SC in combination with established standard-of-care regimens across all currently approved U.S. indications of the intravenous (IV) formulation in MM.
The FDA has set a revised target action date of July 23, 2026. If approved, Sarclisa would become the first anticancer therapy to be delivered via an on-body injector (OBI).
In the United States, the Sarclisa IV formulation is approved in combination with bortezomib, lenalidomide and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant. The drug is also approved in combination with pomalidomide and dexamethasone for patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have progressed on their last treatment. Sarclisa is approved in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
The SC formulation of Sarclisa for the treatment of MM is also under review in the European Union. In March 2026, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of the SC formulation of Sarclisa for administration via both an OBI and manual injection.
Year to date, SNY’s shares have declined 3.2% compared with the industry’s 5.5% fall.
Image Source: Zacks Investment Research
FDA Approves Expanded Use of Sanofi’s Tzield for Kids
The FDA approval for Tzield’s expanded use in young children is based on positive interim data from the phase IV PETITE-T1D study, evaluating Tzield in children under eight years of age diagnosed with stage 2 T1D.
With this approval, Tzield has become 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 in patients aged eight years and older.
Besides the United States, Tzield is also approved in the European Union and several other countries for delaying the onset of stage 3 T1D in adults and children aged eight years and older with stage 2 T1D. Sanofi markets the drug under the brand name of “Teizeild” in the European Union.
Teizeild was added to Sanofi’s portfolio in 2023, following its $2.9 billion acquisition of Provention Bio. The drug was originally developed by MacroGenics (MGNX - Free Report) . Provention Bio acquired this drug from MacroGenics under an asset purchase agreement signed in 2018.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. Over the same period, EPS estimates for 2027 have surged from $2.85 to $3.25. CPRX shares have gained 11.2% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08. Over the same period, EPS estimates for 2027 have surged from $3.22 to $3.41. INDV shares have gained 1.9% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.
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SNY's Tzield Gets FDA Nod for Kids, Sarclisa SC BLA Faces Delay
Key Takeaways
Sanofi (SNY - Free Report) announced that the FDA has approved the supplemental biologic license application (sBLA) seeking to expand the use of Tzield (teplizumab) to delay the onset of stage 3 T1D in individuals aged one year and older with stage 2 disease.
Separately, the FDA has extended the review timeline for the BLA seeking approval for a subcutaneous (SC) formulation of its cancer drug, Sarclisa, for treating multiple myeloma (MM) by up to three months.
Regulatory Update on SNY’s Sarclisa SC
The BLA seeks approval for the use of Sarclisa SC in combination with established standard-of-care regimens across all currently approved U.S. indications of the intravenous (IV) formulation in MM.
The FDA has set a revised target action date of July 23, 2026. If approved, Sarclisa would become the first anticancer therapy to be delivered via an on-body injector (OBI).
In the United States, the Sarclisa IV formulation is approved in combination with bortezomib, lenalidomide and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant. The drug is also approved in combination with pomalidomide and dexamethasone for patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have progressed on their last treatment. Sarclisa is approved in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
The SC formulation of Sarclisa for the treatment of MM is also under review in the European Union. In March 2026, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of the SC formulation of Sarclisa for administration via both an OBI and manual injection.
Year to date, SNY’s shares have declined 3.2% compared with the industry’s 5.5% fall.
Image Source: Zacks Investment Research
FDA Approves Expanded Use of Sanofi’s Tzield for Kids
The FDA approval for Tzield’s expanded use in young children is based on positive interim data from the phase IV PETITE-T1D study, evaluating Tzield in children under eight years of age diagnosed with stage 2 T1D.
With this approval, Tzield has become 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 in patients aged eight years and older.
Besides the United States, Tzield is also approved in the European Union and several other countries for delaying the onset of stage 3 T1D in adults and children aged eight years and older with stage 2 T1D. Sanofi markets the drug under the brand name of “Teizeild” in the European Union.
Teizeild was added to Sanofi’s portfolio in 2023, following its $2.9 billion acquisition of Provention Bio. The drug was originally developed by MacroGenics (MGNX - Free Report) . Provention Bio acquired this drug from MacroGenics under an asset purchase agreement signed in 2018.
Sanofi’s Zacks Rank & Stocks to Consider
SNY currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals (CPRX - 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 Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. Over the same period, EPS estimates for 2027 have surged from $2.85 to $3.25. CPRX shares have gained 11.2% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08. Over the same period, EPS estimates for 2027 have surged from $3.22 to $3.41. INDV shares have gained 1.9% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.