U.S. markets closed
  • S&P Futures

    -23.25 (-0.56%)
  • Dow Futures

    -68.00 (-0.20%)
  • Nasdaq Futures

    -147.00 (-1.10%)
  • Russell 2000 Futures

    -23.30 (-1.05%)
  • Crude Oil

    -0.38 (-0.59%)
  • Gold

    -1.30 (-0.07%)
  • Silver

    -0.10 (-0.37%)

    +0.0009 (+0.07%)
  • 10-Yr Bond

    +0.0250 (+1.59%)
  • Vix

    +2.97 (+17.80%)

    -0.0006 (-0.04%)

    +0.0740 (+0.07%)

    -2,999.23 (-5.11%)
  • CMC Crypto 200

    -96.86 (-6.20%)
  • FTSE 100

    -6.03 (-0.08%)
  • Nikkei 225

    -635.90 (-2.15%)

J&J Files NDA for Erdafitinib in Urothelial Cancer Indication

  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
Zacks Equity Research
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.

Johnson & Johnson JNJ 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 and Merck’s MRK immuno-oncology therapies, Bavencio and Keytruda, respectively are already approved for the UC. Eli Lilly LLY 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>>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Johnson & Johnson (JNJ) : Free Stock Analysis Report
Eli Lilly and Company (LLY) : Free Stock Analysis Report
Merck & Co., Inc. (MRK) : Free Stock Analysis Report
Pfizer Inc. (PFE) : Free Stock Analysis Report
To read this article on Zacks.com click here.