ImmunityBio's Bladder Cancer Drug Drives Record Sales as Legal Deadline Approaches

ImmunityBio reports record $44.2M quarterly sales for its cancer drug ANKTIVA, but faces shareholder lawsuits after an FDA warning letter triggered a 21% stock drop.

ImmunityBio is navigating a stark contrast between its commercial success and a growing legal challenge. The biotech firm reported its strongest quarterly sales to date for its bladder cancer drug ANKTIVA, while simultaneously facing a wave of shareholder lawsuits triggered by a regulatory rebuke. This dual narrative has created significant volatility for the stock.

The company's preliminary net product revenue for the first quarter of 2026 reached approximately $44.2 million. This figure represents a staggering 168% increase year-over-year and a sequential gain of 15% from the fourth quarter of 2025, marking the highest quarterly sales since the drug's launch. Financially, the company is robust, ending the period with a strong liquidity position of nearly $381 million, a substantial increase from roughly $243 million at the end of the previous quarter.

This operational strength is fueled by ANKTIVA's expanding global footprint. The therapy is now approved in five regulatory jurisdictions covering about 34 countries. In a significant expansion, Saudi Arabia granted the first approval for non-small cell lung cancer in January. Clinically, the pivotal BCG-naive CIS trial is fully enrolled, with a supplemental Biologics License Application submission planned for 2026.

However, a legal cloud formed in March. On March 24, 2026, a warning letter from the U.S. Food and Drug Administration (FDA) dated March 13 became public. The letter, addressed directly to CEO Richard Adcock, cited misleading promotional claims about ANKTIVA in a TV advertisement and a podcast, alleging violations of drug marketing laws. The stock reacted violently, plunging 21% in a single session and erasing nearly $2 billion in market capitalization.

That sharp decline prompted immediate legal action. By April 16, at least two law firms had initiated securities class actions. Kessler Topaz Meltzer & Check filed a fraud complaint covering the period from January 19 to March 24, 2026, while Hagens Berman announced an investigation into potential federal securities law violations. In total, five prominent firms are now soliciting lead plaintiffs, with a deadline of May 26, 2026, for investors to come forward. The appointed lead plaintiff will play a decisive role in steering the litigation strategy and any potential settlement talks.

In response to the FDA, ImmunityBio submitted a comprehensive reply on April 6. The company stated it removed the cited podcast, asserted the TV commercial never aired, and pledged to implement stricter internal review processes alongside external regulatory oversight.

The stock's performance reflects this tug-of-war. While shares have gained over 260% since the start of the year, they have shed approximately 13% over the past 30 days. With the pending 10-Q filing and the May 26 legal deadline on the horizon, investors are weighing record-breaking commercial execution against unresolved legal and regulatory risks.