Culver City immunotherapy player ImmunityBio spent January on a tear, riding a run of regulatory wins and a productive stretch with U.S. regulators that yanked its stock out of the low single digits and up past $7. Anktiva, the company’s lead therapy, is billed as both a bladder-sparing treatment and a broader immune-restoring platform, and executives are moving quickly to turn approvals into sales. Between new market sign-offs and a planned regional office, the company’s local footprint is suddenly wired into a global growth story.
Saudi sign-offs and a regional push
On Jan. 14, ImmunityBio said Saudi regulators had cleared Anktiva for new uses, and the company announced plans to open a regional office and partner with Biopharma Cigalah to distribute the drug across the Middle East and North Africa, according to Nasdaq. Executives framed the strategy as pairing regulatory access with local commercial muscle to speed patient access across the region. The updates covered both the company’s bladder program and its lung program, signaling a push that reaches well beyond the U.S. market.
Where Anktiva already stands
Anktiva first won U.S. approval in April 2024, according to the company’s SEC filing (SEC filing). The MHRA approved the therapy for BCG-unresponsive non-muscle-invasive bladder cancer in mid-2025, and the European Medicines Agency’s committee adopted a positive opinion recommending conditional marketing authorization in December 2025, per the EMA. Together, those regulatory milestones have helped ImmunityBio argue for wider indications and a broader international rollout.
FDA meeting and next steps
On Jan. 20 ImmunityBio said it held a Type B end-of-phase meeting with the U.S. Food and Drug Administration about a supplemental Biologics License Application to extend Anktiva’s label to papillary bladder tumors. The company reported that the FDA recommended providing additional information for the agency’s consideration and did not request a new clinical trial, and ImmunityBio said it would submit the requested materials within 30 days, according to ImmunityBio. That exchange set a clearer near-term regulatory path that investors quickly latched onto, even as the agency’s final decision still depends on the resubmission review.
Money and market reaction
The regulatory momentum helped fuel a January surge that sent shares from roughly $2.82 on Jan. 13 to a peak above $7 later in the month as trading volume spiked. ImmunityBio also reported preliminary net product revenue of about $113 million for fiscal 2025, and, as CEO Richard Adcock put it, “We delivered strong quarter-over-quarter revenue growth, reflecting accelerating adoption of ANKTIVA and the continued execution of our commercial strategy,” per the company update (ImmunityBio). The company cited a 700 increase year over year. The mix of new approvals, rising sales and the FDA sit-down boosted analyst attention and left the stock sitting far higher than it was a month earlier, according to Los Angeles Business Journal.
What Culver City should watch next
Locally, the company’s Culver City operations will be focused on enrollment and the resubmission timeline: ImmunityBio says its registrational trial is nearing completion and it expects additional filings and regulatory activity through 2026. Analysts have already revised price targets and are tracking the resubmission and Europe’s final decision, according to reporting by Benzinga. For patients, clinicians and local biotech workers, the coming months will show whether all these approvals turn into sustained sales, manufacturing growth and new hiring.
