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ImmunityBio Takes Another Shot At FDA Approval For Its Cancer Drug

MarketDash
The biotech company has resubmitted its application for expanded use of ANKTIVA in bladder cancer, hoping to overcome a previous regulatory rejection.

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Shares of ImmunityBio Inc. (IBRX) were trading lower on Monday, but the real story is what the company is trying to do: get its lead drug approved for more patients.

The company announced it has resubmitted its supplemental Biologics License Application (sBLA) for ANKTIVA to the FDA. This is for using the drug, in combination with another therapy called BCG, to treat a type of bladder cancer known as BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease.

Think of it as a second attempt. The FDA has acknowledged receipt of the new application, which follows months of discussions that started back in January. The agency had asked for more data, which ImmunityBio provided in March.

This whole process kicked off because of a setback last year. In May 2025, the FDA sent ImmunityBio a "Refusal to File" letter for this exact application. That's essentially the regulator saying, "We're not even going to review this yet because the application isn't complete." It was a pause, not necessarily a denial of the drug's merits, but it meant the company had to go back and gather more information to make its case.

What the Charts Are Saying

While the company navigates the regulatory maze, the stock tells its own story. Technically, it's a bit of a mixed bag right now.

The stock is trading slightly below its 20-day average but is sitting a hefty 41.3% above its 100-day average. That suggests the longer-term trend has been very strong, even if there's some short-term softness. That long-term strength is backed up by the numbers: shares are up a staggering 184.54% over the past 12 months and are trading much closer to their 52-week highs than their lows.

Digging into the indicators, the Relative Strength Index (RSI) is at 55.12, which is right in neutral territory—the stock isn't considered overbought or oversold. However, the MACD indicator is showing a bearish signal, sitting below its signal line. So, you have neutral momentum from one measure and a hint of bearish pressure from another. It paints a picture of a stock that has run up a lot and might be taking a breather as traders wait for the next catalyst, like news from the FDA.

On the chart, traders are watching key resistance at $12.50 and key support at $7.00.

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Weekly insights + SMS (optional)

What the Analysts Think

The analyst community hasn't been scared off by the regulatory hurdles. The consensus rating on the stock is a Buy, with an average price target of $12.50. Recent moves show continued optimism:

  • Piper Sandler: Overweight rating, raised price target to $12.00 (March 4).
  • HC Wainwright & Co.: Buy rating, raised price target to $15.00 (February 23).
  • D. Boral Capital: Buy rating, maintained a price target of $23.00 (February 23).

Market data also shows the stock has a very strong momentum score compared to the broader market, indicating it has been a notable outperformer.

For ETF investors, the stock has notable exposure in the Virtus LifeSci Biotech Products ETF (BBP), where it carries a 4.03% weight.

When the market closed on Monday, ImmunityBio shares were down 1.56% at $8.53. All eyes are now on the FDA's response to this resubmission, which will determine the next chapter for the company's flagship drug.

ImmunityBio Takes Another Shot At FDA Approval For Its Cancer Drug

MarketDash
The biotech company has resubmitted its application for expanded use of ANKTIVA in bladder cancer, hoping to overcome a previous regulatory rejection.

Get Market Alerts

Weekly insights + SMS alerts

Shares of ImmunityBio Inc. (IBRX) were trading lower on Monday, but the real story is what the company is trying to do: get its lead drug approved for more patients.

The company announced it has resubmitted its supplemental Biologics License Application (sBLA) for ANKTIVA to the FDA. This is for using the drug, in combination with another therapy called BCG, to treat a type of bladder cancer known as BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease.

Think of it as a second attempt. The FDA has acknowledged receipt of the new application, which follows months of discussions that started back in January. The agency had asked for more data, which ImmunityBio provided in March.

This whole process kicked off because of a setback last year. In May 2025, the FDA sent ImmunityBio a "Refusal to File" letter for this exact application. That's essentially the regulator saying, "We're not even going to review this yet because the application isn't complete." It was a pause, not necessarily a denial of the drug's merits, but it meant the company had to go back and gather more information to make its case.

What the Charts Are Saying

While the company navigates the regulatory maze, the stock tells its own story. Technically, it's a bit of a mixed bag right now.

The stock is trading slightly below its 20-day average but is sitting a hefty 41.3% above its 100-day average. That suggests the longer-term trend has been very strong, even if there's some short-term softness. That long-term strength is backed up by the numbers: shares are up a staggering 184.54% over the past 12 months and are trading much closer to their 52-week highs than their lows.

Digging into the indicators, the Relative Strength Index (RSI) is at 55.12, which is right in neutral territory—the stock isn't considered overbought or oversold. However, the MACD indicator is showing a bearish signal, sitting below its signal line. So, you have neutral momentum from one measure and a hint of bearish pressure from another. It paints a picture of a stock that has run up a lot and might be taking a breather as traders wait for the next catalyst, like news from the FDA.

On the chart, traders are watching key resistance at $12.50 and key support at $7.00.

Get Market Alerts

Weekly insights + SMS (optional)

What the Analysts Think

The analyst community hasn't been scared off by the regulatory hurdles. The consensus rating on the stock is a Buy, with an average price target of $12.50. Recent moves show continued optimism:

  • Piper Sandler: Overweight rating, raised price target to $12.00 (March 4).
  • HC Wainwright & Co.: Buy rating, raised price target to $15.00 (February 23).
  • D. Boral Capital: Buy rating, maintained a price target of $23.00 (February 23).

Market data also shows the stock has a very strong momentum score compared to the broader market, indicating it has been a notable outperformer.

For ETF investors, the stock has notable exposure in the Virtus LifeSci Biotech Products ETF (BBP), where it carries a 4.03% weight.

When the market closed on Monday, ImmunityBio shares were down 1.56% at $8.53. All eyes are now on the FDA's response to this resubmission, which will determine the next chapter for the company's flagship drug.