J&J (JNJ) Seeks Approval for Bladder Cancer Drug in Europe
Johnson & Johnson JNJ announced that it has submitted a regulatory application to the European Medicines Agency (EMA) seeking approval for erdafitinib for treating FGFR-altered locally-advanced or metastatic urothelial cancer (UC) in Europe.
The marketing authorization application (MAA) was based on data from a cohort of a phase III study called THOR, which evaluated the efficacy and safety of erdafitinib, an investigational, once-daily oral FGFR tyrosine kinase inhibitor, versus chemotherapy. Data from this cohort of the THOR study showed that Balversa reduced the risk of death in patients with advanced, FGFR-altered UC by 36% versus chemotherapy. This data was presented at the annual meeting of the American Society of Clinical Oncology in June.
J&J’s stock has declined 9.1% so far this year against an increase of 8.4% for the industry
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Urothelial carcinoma (UC) is the most common form of bladder cancer. More than 90% of bladder cancers are UCs. In 2020, more than 203,000 individuals were diagnosed with bladder cancer in Europe. Around 20% of patients with metastatic UC (mUC) have alterations in their FGFR genes, creating significant demand for novel and targeted therapies for advanced UC patients, including those with FGFR-driven tumors.
Erdafitinib is already marketed as Balversa in the United States for FGFR-altered metastatic UC. Balversa was approved by the FDA under the accelerated pathway in 2019. Last month, J&J submitted a supplemental new drug application (sNDA) to the FDA to get the accelerated approval of Balversa converted to a full approval based on the same data from the cohort of the THOR study, as discussed above. Erdafitinib is being studied in several other phase II and III studies in patients with advanced UC.
Zacks Rank & Stocks to Consider
J&J currently has a Zacks Rank #3 (Hold).
Johnson & Johnson Price and Consensus
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In the past 60 days, the Zacks Consensus Estimate for Corcept’s earnings has gone up from 62 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 61 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 62.2% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
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