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JNJ Seeks Label Expansion of Multiple Myeloma Drug Tecvayli in the EU
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Key Takeaways
JNJ submitted a type II variation to the EMA to expand Tecvayli monotherapy for RRMM patients.
JNJ's phase III MajesTEC-9 showed 71% lower progression or death risk and 40% lower death risk.
Johnson & Johnson reported $670M Tecvayli sales in 2025, up 22%, driven by expansion into community settings.
Johnson & Johnson (JNJ - Free Report) announced that it has submitted a type II variation application to the European Medicines Agency (EMA) seeking approval for the expanded use of Tecvayli (teclistamab). The application seeks to expand Tecvayli’s label as a monotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy.
Tecvayli is currently approved in Europe for treating patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have shown disease progression on the last therapy.
Over the past year, JNJ’s shares have risen 49.6% compared with the industry’s 14.3% growth.
Image Source: Zacks Investment Research
EMA Submission Backed by JNJ’s Phase III MajesTEC-9 Study
The type II variation application for Tecvayli is supported by data from the ongoing phase III MajesTEC-9 study, which evaluated the efficacy and safety of the drug versus standard-of-care regimens including pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with RRMM.
Results showed that teclistamab significantly improved outcomes compared with the standard of care, delivering superior progression-free survival and overall survival as early as the second-line setting. The therapy reduced the risk of disease progression or death by 71% and lowered the risk of death by 40% in a patient population that was largely refractory to anti-CD38 monoclonal antibodies and lenalidomide.
Tecvayli monotherapy showed a manageable safety profile consistent with previously reported data, with no new safety signals identified.
More on JNJ’s Tecvayli
Tecvayli is also approved in the United States for the treatment of RRMM, both as monotherapy in heavily pretreated patients and in combination therapy in earlier treatment lines.
The FDA granted accelerated approval in October 2022 for adults with RRMM who had received at least four prior lines of therapy.
Earlier this month, the FDA also approved the drug in combination with Darzalex Faspro for the treatment of adults with RRMM who have received at least one prior line of therapy, including an immunomodulatory agent and a proteasome inhibitor.
In January, JNJ submitted a type II variation application to the EMA seeking approval for the expanded use of Tecvayli in combination with the Darzalex subcutaneous (daratumumab SC) formulation for the treatment of adult patients with RRMM who have received at least one prior therapy. The application is supported by data from the phase III MajesTEC-3 study.
Tecvayli recorded global sales of $670 million in 2025, up 22% year over year, driven by continued expansion into the community setting.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.82. CPRX shares have gained 16.9% over the past year.
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 ANI Pharmaceuticals’ earnings per share have increased from $8.28 to $9.00 for 2026. Over the past year, shares of ANIP have surged 20%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.11 to $1.06. CSTL shares have risen 35.5% over the past year.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 34.69%.
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JNJ Seeks Label Expansion of Multiple Myeloma Drug Tecvayli in the EU
Key Takeaways
Johnson & Johnson (JNJ - Free Report) announced that it has submitted a type II variation application to the European Medicines Agency (EMA) seeking approval for the expanded use of Tecvayli (teclistamab). The application seeks to expand Tecvayli’s label as a monotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy.
Tecvayli is currently approved in Europe for treating patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have shown disease progression on the last therapy.
Over the past year, JNJ’s shares have risen 49.6% compared with the industry’s 14.3% growth.
Image Source: Zacks Investment Research
EMA Submission Backed by JNJ’s Phase III MajesTEC-9 Study
The type II variation application for Tecvayli is supported by data from the ongoing phase III MajesTEC-9 study, which evaluated the efficacy and safety of the drug versus standard-of-care regimens including pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with RRMM.
Results showed that teclistamab significantly improved outcomes compared with the standard of care, delivering superior progression-free survival and overall survival as early as the second-line setting. The therapy reduced the risk of disease progression or death by 71% and lowered the risk of death by 40% in a patient population that was largely refractory to anti-CD38 monoclonal antibodies and lenalidomide.
Tecvayli monotherapy showed a manageable safety profile consistent with previously reported data, with no new safety signals identified.
More on JNJ’s Tecvayli
Tecvayli is also approved in the United States for the treatment of RRMM, both as monotherapy in heavily pretreated patients and in combination therapy in earlier treatment lines.
The FDA granted accelerated approval in October 2022 for adults with RRMM who had received at least four prior lines of therapy.
Earlier this month, the FDA also approved the drug in combination with Darzalex Faspro for the treatment of adults with RRMM who have received at least one prior line of therapy, including an immunomodulatory agent and a proteasome inhibitor.
In January, JNJ submitted a type II variation application to the EMA seeking approval for the expanded use of Tecvayli in combination with the Darzalex subcutaneous (daratumumab SC) formulation for the treatment of adult patients with RRMM who have received at least one prior therapy. The application is supported by data from the phase III MajesTEC-3 study.
Tecvayli recorded global sales of $670 million in 2025, up 22% year over year, driven by continued expansion into the community setting.
JNJ’s Zacks Rank & Stocks to Consider
JNJ currently carries a Zacks Rank #3 (Hold).
Some top-ranked stocks in the biotech sector are Catalyst Pharmaceuticals (CPRX - Free Report) , which currently sports a Zacks Rank #1 (Strong Buy), and ANI Pharmaceuticals (ANIP - Free Report) and Castle Biosciences (CSTL - Free Report) , both of which carry a Zacks Rank #2 (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 $2.82. CPRX shares have gained 16.9% over the past year.
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 ANI Pharmaceuticals’ earnings per share have increased from $8.28 to $9.00 for 2026. Over the past year, shares of ANIP have surged 20%.
ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.11 to $1.06. CSTL shares have risen 35.5% over the past year.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 34.69%.