U.S. Markets open in 6 hrs 14 mins
  • S&P Futures

    +12.50 (+0.27%)
  • Dow Futures

    +71.00 (+0.20%)
  • Nasdaq Futures

    +54.00 (+0.33%)
  • Russell 2000 Futures

    +10.40 (+0.46%)
  • Crude Oil

    -0.64 (-0.89%)
  • Gold

    +5.50 (+0.31%)
  • Silver

    -0.07 (-0.30%)

    +0.0015 (+0.1355%)
  • 10-Yr Bond

    0.0000 (0.00%)
  • Vix

    -6.06 (-21.68%)

    +0.0004 (+0.0305%)

    -0.0970 (-0.0854%)

    -453.04 (-0.89%)
  • CMC Crypto 200

    -125.54 (-8.71%)
  • FTSE 100

    +5.11 (+0.07%)
  • Nikkei 225

    +405.02 (+1.42%)

Infinity's IPI-549 Gets Fast Track Tag for Urothelial Cancer

  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
·3 min read
In this article:
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.

Shares of Infinity Pharmaceuticals, Inc. INFI were up 12% yesterday after the FDA granted a Fast Track designation to the combo of IPI-549 plus Bristol Myers’ BMY Opdivo (nivolumab) for the treatment of advanced urothelial cancer, a type of bladder cancer.

However, the stock has plunged 48.2% in the past year compared with the industry’s decrease of 30.3%.


The fast track tag from the FDA is designed to provide certain benefits for new drugs/vaccines and expedite its review time for the same that treats serious or life-threatening conditions and demonstrates the potential to address the unmet medical needs.

Notably, during the fourth quarter of 2019, the company initiated MARIO-275, an ongoing, global, randomized, controlled phase II study in collaboration with Bristol-Myers Squibb, to evaluate IPI-549 in combination with the latter’s PD-1 immune checkpoint inhibitor Opdivo in platinum-refractory, I/O-naive patients with advanced urothelial cancer. Infinity is currently enrolling patients in the study. Completion of recruitment is expected in 2020 and data, by mid-2021.

We remind investors that Infinity is currently focused on developing its lead immuno-oncology candidate, IPI-549.

The company is evaluating IPI-549 as a monotherapy and in combination with Bristol-Myers’ Opdivo in a phase I/Ib study (MARIO-1) in about 200 patients afflicted with advanced solid tumors. The company completed enrolment in MARIO-1 during the fourth quarter. Additional findings from the study is expected later this year.

This apart, in September 2019, Infinity initiated a phase II MARIO-3 study in collaboration with Roche AG RHHBY evaluating IPI-549 in combination with Tecentriq and Abraxane (nab-paclitaxel) for the treatment of front-line triple negative breast cancer (TNBC). The above-mentioned study also includes a cohort evaluating IPI-549 in combination with Tecentriq and Avastin (bevacizumab) for front-line PDL1+ and PDL1- renal cell cancer (RCC) patients. Infinity plans to present the outcomes from the same later in 2020.

Meanwhile, Infinity in collaboration with Arcus Biosciences RCUS is conducting an early-stage study to evaluate IPI-549 in combination with AB298, the latter's dual adenosine receptor antagonist, and Doxil, a chemotherapy, for treating patients with advanced TNBC.

If successfully developed in any of the studies and approved by the concerned regulatory agencies, IPI-549 will offer a huge boost to Infinity in the days ahead.

Zacks Rank

Infinity currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Just Released: Zacks’ 7 Best Stocks for Today

Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.5% per year.

These 7 were selected because of their superior potential for immediate breakout.

See these time-sensitive tickers now >>

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
Roche Holding AG (RHHBY) : Free Stock Analysis Report
Bristol-Myers Squibb Company (BMY) : Free Stock Analysis Report
Infinity Pharmaceuticals, Inc. (INFI) : Free Stock Analysis Report
Arcus Biosciences, Inc. (RCUS) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research