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J&J (JNJ) Seeks Full FDA Nod for Balversa in Urothelial Cancer
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Johnson & Johnson (JNJ - Free Report) announced that it has submitted a supplemental new drug application (sNDA) to the FDA seeking full approval for Balversa (erdafitinib) as a treatment for patients with metastatic or unresectable urothelial carcinoma (UC), a type of bladder cancer.
Balversa, a kinase inhibitor, was approved by the FDA under the accelerated pathway in 2019 for the treatment of adults with locally advanced or metastatic UC which has susceptible FGFR3 or FGFR2 genetic alterations and who progressed during or following treatment. Balversa was the first FGFR kinase inhibitor to receive FDA approval in 2019.
The sNDA is based on positive data from cohort I of the phase III THOR study. 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.
Shares of J&J have lost 7.0% year to date against the industry’s 7.5% growth.
Image Source: Zacks Investment Research
Apart from THOR study, JNJ is also evaluating Balversa in a couple of other studies for treating bladder cancer. One is a mid-stage THOR-2 study in patients who earlier received Bacillus Calmette-Guérin vaccine and recurred with high-risk non-muscle-invasive bladder cancer. The other is an early-stage study in patients with non-muscle invasive or muscle invasive bladder cancer with select FGFR alterations.
In the past 90 days, the Zacks Consensus Estimate forANI Pharmaceuticals’ earnings has gone up from $3.31 per share to $3.73 for 2023. The bottom-line estimate has increased from $4.32 to $4.35 for 2024 during the same time frame. Shares of the company have rallied 56% year to date.
ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise 91.56%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to $2.77 for 2024 during the same time frame. Shares of the company have lost 7.3% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
In the past 90 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 58.6% 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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J&J (JNJ) Seeks Full FDA Nod for Balversa in Urothelial Cancer
Johnson & Johnson (JNJ - Free Report) announced that it has submitted a supplemental new drug application (sNDA) to the FDA seeking full approval for Balversa (erdafitinib) as a treatment for patients with metastatic or unresectable urothelial carcinoma (UC), a type of bladder cancer.
Balversa, a kinase inhibitor, was approved by the FDA under the accelerated pathway in 2019 for the treatment of adults with locally advanced or metastatic UC which has susceptible FGFR3 or FGFR2 genetic alterations and who progressed during or following treatment. Balversa was the first FGFR kinase inhibitor to receive FDA approval in 2019.
The sNDA is based on positive data from cohort I of the phase III THOR study. 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.
Shares of J&J have lost 7.0% year to date against the industry’s 7.5% growth.
Image Source: Zacks Investment Research
Apart from THOR study, JNJ is also evaluating Balversa in a couple of other studies for treating bladder cancer. One is a mid-stage THOR-2 study in patients who earlier received Bacillus Calmette-Guérin vaccine and recurred with high-risk non-muscle-invasive bladder cancer. The other is an early-stage study in patients with non-muscle invasive or muscle invasive bladder cancer with select FGFR alterations.
Johnson & Johnson Price and Consensus
Johnson & Johnson price-consensus-chart | Johnson & Johnson Quote
Zacks Rank & Other Stocks to Consider
JNJ currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the same industry are ANI Pharmaceuticals (ANIP - Free Report) , Annovis Bio (ANVS - Free Report) and Corcept Therapeutics (CORT - Free Report) , each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate forANI Pharmaceuticals’ earnings has gone up from $3.31 per share to $3.73 for 2023. The bottom-line estimate has increased from $4.32 to $4.35 for 2024 during the same time frame. Shares of the company have rallied 56% year to date.
ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise 91.56%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to $2.77 for 2024 during the same time frame. Shares of the company have lost 7.3% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
In the past 90 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 58.6% 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%.