We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
J&J Files NDA for Erdafitinib in Urothelial Cancer Indication
Read MoreHide Full Article
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.
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.
Image: Bigstock
J&J Files NDA for Erdafitinib in Urothelial Cancer Indication
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.
Johnson & Johnson Price
Johnson & Johnson Price | Johnson & Johnson Quote
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>>