Johnson & Johnson (JNJ - Free Report) announced that its subsidiary Janssen has filed a new drug application (“NDA”) seeking approval of its pan-FGFR inhibitor, erdafitinib, as a treatment for metastatic urothelial cancer (“UC”), a type of bladder cancer. The NDA seeks approval of the candidate for treating UC in patients with certain fibroblast growth factor receptor (“FGFR”) genetic alterations and whose tumors have progressed after prior chemotherapy.
The candidate enjoys Breakthrough Therapy designation, which is expected to translate to a speedy review of the regulatory application once accepted by the FDA.
J&J stock has declined 0.6% this year so far against 6.2% increase recorded by the industry.
The NDA includes data from a phase II study, evaluating erdafitinib in advanced urothelial cancer indication and showed an overall response rate of 42%. The study data were presented at the annual meeting of ASCO 2018 and selected as "Best of ASCO".
Per the press release, urothelial cancer is the sixth most common cancer type affecting people in the United States. Bladder cancer is estimated to be diagnosed in 81,190 new patients in 2018 and will cause death of 17,240 patients. Moreover this patient population has witnessed poor outcomes when treated with available therapies. In fact, only 5% of the patients diagnosed with Stage IV metastatic bladder cancer survive beyond five years of treatment. Also, patients with FGFR mutation have poor prognosis and significant unmet need.
Pfizer’s (PFE - Free Report) and Merck’s (MRK - Free Report) immuno-oncology therapies, Bavencio and Keytruda, respectively are already approved for the UC. Eli Lilly (LLY - Free Report) is developing its cancer drug, Cyramza for UC in a late-stage study. Nektar Therapeutics and Bristol-Myers are developing a combination of immuno-oncology products, NKTR-214 and Opdivo, respectively in an early stage study. Several other pharma companies have approved drugs or developing candidates in their portfolio for treating UC.
Zacks Rank
J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Johnson & Johnson (JNJ - Free Report) announced that its subsidiary Janssen has filed a new drug application (“NDA”) seeking approval of its pan-FGFR inhibitor, erdafitinib, as a treatment for metastatic urothelial cancer (“UC”), a type of bladder cancer. The NDA seeks approval of the candidate for treating UC in patients with certain fibroblast growth factor receptor (“FGFR”) genetic alterations and whose tumors have progressed after prior chemotherapy.
The candidate enjoys Breakthrough Therapy designation, which is expected to translate to a speedy review of the regulatory application once accepted by the FDA.
J&J stock has declined 0.6% this year so far against 6.2% increase recorded by the industry.
The NDA includes data from a phase II study, evaluating erdafitinib in advanced urothelial cancer indication and showed an overall response rate of 42%. The study data were presented at the annual meeting of ASCO 2018 and selected as "Best of ASCO".
Per the press release, urothelial cancer is the sixth most common cancer type affecting people in the United States. Bladder cancer is estimated to be diagnosed in 81,190 new patients in 2018 and will cause death of 17,240 patients. Moreover this patient population has witnessed poor outcomes when treated with available therapies. In fact, only 5% of the patients diagnosed with Stage IV metastatic bladder cancer survive beyond five years of treatment. Also, patients with FGFR mutation have poor prognosis and significant unmet need.
Pfizer’s (PFE - Free Report) and Merck’s (MRK - Free Report) immuno-oncology therapies, Bavencio and Keytruda, respectively are already approved for the UC. Eli Lilly (LLY - Free Report) is developing its cancer drug, Cyramza for UC in a late-stage study. Nektar Therapeutics and Bristol-Myers are developing a combination of immuno-oncology products, NKTR-214 and Opdivo, respectively in an early stage study. Several other pharma companies have approved drugs or developing candidates in their portfolio for treating UC.
Zacks Rank
J&J currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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