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J&J (JNJ) Gets EU Approval for Bladder Cancer Drug Balversa
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Johnson & Johnson (JNJ - Free Report) announced that the European Commission has granted marketing approval to its drug Balversa (erdafitinib) for treating unresectable or metastatic urothelial carcinoma (UC), harboring susceptible FGFR3 genetic alterations.
The drug has been approved for UC patients who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting.
UC is the most common type of bladder cancer. Europe has the highest rate of bladder cancer cases than any other continent. Around 20% of patients with metastatic urothelial carcinoma have FGFR alterations, who until now have limited treatment options. This created the need for novel, targeted medicines like Balversa.
So far this year, J&J’s shares have risen 4.7% compared with the industry’s 27.4% increase.
Image Source: Zacks Investment Research
The approval was expected as, in June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended marketing authorization to Balversa, a kinase inhibitor, for the indication. The approval was based on results from cohort 1 of the phase III THOR study, which evaluated the efficacy and safety of Balversa versus chemotherapy. The THOR study met its primary endpoint of overall survival (OS). Data from the study showed that patients who received Balversa achieved a median OS of more than one year and Balversa reduced the risk of death in patients by 36% versus chemotherapy.
Balversa was approved by the FDA under the accelerated pathway in 2019 for FGFR-altered locally-advanced or metastatic UC. The accelerated approval was later converted to a full approval by the FDA in January this year.
Apart from the THOR study, J&J is also evaluating Balversa in several other studies in patients with bladder cancer.
In the past 30 days, 2024 earnings estimates for Roche have improved from $2.53 per share to $2.68 per share. For 2025, earnings estimates have improved from $2.73 per share to $2.87 per share over the same timeframe. Roche’s shares have risen 15.2% year to date.
In the past 30 days, loss estimates for 2024 for Arcturus Therapeutics have improved from $4.39 per share to $2.60 per share. Estimates for 2025 have improved from a loss of 45 cents per share to earnings of 21 cents per share. Year to date, shares of Arcturus Therapeutics have declined 30.3%.
Earnings of Arcturus Therapeutics beat estimates in each of the last four quarters. ARCT delivered a four-quarter average earnings surprise of 56.73%
Estimates for Lilly’s 2024 earnings have risen from $13.76 to $15.77 per share over the past 30 days. For 2025, earnings estimates have risen from $19.44 to $22.79 per share over the same timeframe. Year to date, Lilly’s stock has risen 63.5%.
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.
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J&J (JNJ) Gets EU Approval for Bladder Cancer Drug Balversa
Johnson & Johnson (JNJ - Free Report) announced that the European Commission has granted marketing approval to its drug Balversa (erdafitinib) for treating unresectable or metastatic urothelial carcinoma (UC), harboring susceptible FGFR3 genetic alterations.
The drug has been approved for UC patients who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting.
UC is the most common type of bladder cancer. Europe has the highest rate of bladder cancer cases than any other continent. Around 20% of patients with metastatic urothelial carcinoma have FGFR alterations, who until now have limited treatment options. This created the need for novel, targeted medicines like Balversa.
So far this year, J&J’s shares have risen 4.7% compared with the industry’s 27.4% increase.
Image Source: Zacks Investment Research
The approval was expected as, in June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended marketing authorization to Balversa, a kinase inhibitor, for the indication. The approval was based on results from cohort 1 of the phase III THOR study, which evaluated the efficacy and safety of Balversa versus chemotherapy. The THOR study met its primary endpoint of overall survival (OS). Data from the study showed that patients who received Balversa achieved a median OS of more than one year and Balversa reduced the risk of death in patients by 36% versus chemotherapy.
Balversa was approved by the FDA under the accelerated pathway in 2019 for FGFR-altered locally-advanced or metastatic UC. The accelerated approval was later converted to a full approval by the FDA in January this year.
Apart from the THOR study, J&J is also evaluating Balversa in several other studies in patients with bladder cancer.
Zacks Rank and Stocks to Consider
J&J currently has a Zacks Rank #4 (Sell).
Johnson & Johnson Price and Consensus
Johnson & Johnson price-consensus-chart | Johnson & Johnson Quote
Some better-ranked drug/biotech companies are Roche (RHHBY - Free Report) , Arcturus Therapeutics Holdings (ARCT - Free Report) and Eli Lilly (LLY - Free Report) . While Roche and Arcturus Therapeutics Holdings sport a Zacks Rank #1 (Strong Buy) each, Lilly has a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, 2024 earnings estimates for Roche have improved from $2.53 per share to $2.68 per share. For 2025, earnings estimates have improved from $2.73 per share to $2.87 per share over the same timeframe. Roche’s shares have risen 15.2% year to date.
In the past 30 days, loss estimates for 2024 for Arcturus Therapeutics have improved from $4.39 per share to $2.60 per share. Estimates for 2025 have improved from a loss of 45 cents per share to earnings of 21 cents per share. Year to date, shares of Arcturus Therapeutics have declined 30.3%.
Earnings of Arcturus Therapeutics beat estimates in each of the last four quarters. ARCT delivered a four-quarter average earnings surprise of 56.73%
Estimates for Lilly’s 2024 earnings have risen from $13.76 to $15.77 per share over the past 30 days. For 2025, earnings estimates have risen from $19.44 to $22.79 per share over the same timeframe. Year to date, Lilly’s stock has risen 63.5%.
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.