ImmunityBio Stock Soars 11% as Anktiva Momentum and FDA Catalyst Hopes Fuel Rally in Soon-Shiong's Biotech

NEW YORK — Shares of ImmunityBio Inc. jumped more than 11% on Wednesday, extending a volatile run for the cancer immunotherapy developer as investors bet on continued growth of its bladder cancer drug Anktiva and a key U.S. regulatory decision early next year.

The stock rose $1.01, or 11.44%, to $9.84 as of 11:43 a.m. Eastern time on the Nasdaq, putting it on track for one of its strongest sessions in weeks and pushing it closer to its 52-week high of $12.43.

The company did not issue a major announcement Wednesday morning, and there was no single confirmed catalyst for the move. The gain builds on a rally earlier in the week and comes as the San Diego-based biotech heads into a string of closely watched regulatory and commercial milestones.

Rally builds through the week

ImmunityBio shares have gained ground in each of the past several sessions. On Monday, the stock rose about 5% from a previous close of $8.44, according to MarketBeat data, which attributed the move to an analyst upgrade by Jefferies. Shares added to those gains on Tuesday before Wednesday's jump.

The stock has been one of the market's most volatile biotech names this year. It has swung between a 52-week low of $1.95 and a high of $12.43, and it was up roughly 300% year-to-date as of early September.

Short sellers remain heavily positioned against the company. Short interest stood at about 125.6 million shares, or roughly 31% of the float, according to recent data, which can amplify price swings when buyers step in.

Options activity has also been elevated. Earlier this month, call volume in ImmunityBio ran well above normal, a sign that some traders were positioning for further gains.

Anktiva sales accelerate

Much of the enthusiasm around ImmunityBio centers on Anktiva, its immunotherapy approved in combination with the tuberculosis vaccine BCG for certain patients with non-muscle invasive bladder cancer who no longer respond to BCG alone.

The company reported record net product revenue of $50.7 million for the second quarter of 2026, up 92% from a year earlier. First-half revenue rose 121% to $94.8 million, reflecting a steady climb from just $7.2 million in the fourth quarter of 2024.

The company still posted a loss for the quarter. ImmunityBio reported a loss of 22 cents per share, wider than analysts' consensus estimate of 8 cents, while revenue of $51.24 million topped forecasts of $49.70 million, according to MarketBeat.

Anktiva has expanded well beyond the U.S. market. The drug is approved in the United Kingdom, has received a conditional marketing authorization recommendation in the European Union, and recently won marketing authorization in the United Arab Emirates for bladder cancer and metastatic non-small cell lung cancer.

FDA decision on the horizon

Investors are also focused on an upcoming Food and Drug Administration decision that could significantly widen Anktiva's use.

The FDA accepted ImmunityBio's supplemental biologics license application for Anktiva plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease, setting a target action date of Jan. 6, 2027. Approval would expand the drug's label to a broader group of bladder cancer patients.

The company has also secured U.S. patents covering the combination of Anktiva and BCG with terms running through 2035, strengthening its intellectual property protection.

In addition, ImmunityBio has said it plans to submit a new biologics license application to the FDA during the fourth quarter of 2026.

International expansion

ImmunityBio's stock has also responded to signs of global expansion. Shares jumped nearly 10% on Sept. 22 after company founder Patrick Soon-Shiong met with Turkish President Recep Tayyip Erdogan, fueling optimism about the company's planned expansion into Turkey.

Soon-Shiong shared a photo of the meeting on social media with the caption: "Under his leadership, Turkey will be the center of excellence for patients with cancer in the region."

Soon-Shiong, a billionaire surgeon and biotech entrepreneur who also owns the Los Angeles Times, founded ImmunityBio in 2014. Insiders own about 66% of the company's stock.

Earlier this month, shares rose about 6% after Soon-Shiong's Nant Capital agreed to invest up to $22.3 million in PDS Biotech, with Soon-Shiong taking a seat on that company's board.

Regulatory and legal overhangs

Despite its commercial progress, ImmunityBio faces ongoing scrutiny. The FDA sent the company a warning letter in March over promotional materials for Anktiva, including a television ad and a podcast appearance by Soon-Shiong, saying the company presented the drug in a misleading way. The agency had previously issued two untitled letters over similar concerns in September 2025 and January 2026.

The warning letter triggered a sharp drop in the stock and led to a securities class action lawsuit. Defendants have since moved to dismiss the case, which centers on statements made in the podcast.

The regulatory issues did not affect Anktiva's approval status, but analysts have described the repeated FDA correspondence as a compliance risk for the company.

Analysts remain bullish

Wall Street sentiment toward the stock remains largely positive. Based on MarketBeat data, ImmunityBio holds a consensus rating of "Moderate Buy" with an average price target of $14.20, well above current trading levels. HC Wainwright has a buy rating and a $15 price target on the stock.

Not all analysts agree. Weiss Ratings maintains a sell rating on the shares, reflecting the company's continued losses and elevated volatility.

The company has a market value of more than $9 billion but has yet to turn a profit, leaving it vulnerable to sharp swings tied to regulatory news, sales trends and broader market sentiment.

ImmunityBio is expected to report its third-quarter results on Nov. 3, when investors will look for further evidence that Anktiva sales are continuing to accelerate.

Beyond that, the Jan. 6 FDA decision on the drug's expanded label stands as the company's biggest near-term catalyst. A positive ruling could open Anktiva to a significantly larger pool of bladder cancer patients, while any setback could test the stock's sharp gains this year.