New York, May 16, 2026, 18:02 EDT
- ImmunityBio ended Friday at $7.97, losing 2.2% on the session and down roughly 6.3% for the week. U.S. stock markets were closed Saturday. Nasdaq’s normal trading hours run Monday through Friday, 9:30 a.m. to 4 p.m. EDT.
- ImmunityBio, Inc. said it has locked in exclusive U.S. rights with Japan BCG Laboratory for the Tokyo-172 strain, which is used in bladder-cancer treatment. The company said it will talk with the FDA about its regulatory plans.
- Investors face a new supply angle next week as they weigh FDA and funding risks. Q1 product revenue climbed to $44.2 million, and cash plus marketable securities hit $380.9 million.
ImmunityBio Inc. (IBRX.O) shares will react Monday to news of a fresh bladder-cancer supply agreement. The company said Saturday it now has exclusive U.S. rights to develop, import and sell the Tokyo-172 BCG strain from Japan BCG Laboratory.
ImmunityBio’s main drug Anktiva is already approved to be used with Bacillus Calmette-Guerin, or BCG, for some non-muscle invasive bladder cancers, meaning cancers that haven’t spread into the bladder wall. BCG was first developed as a tuberculosis vaccine but is also given in the bladder to kickstart the immune system against tumors. ImmunityBio said its new Japan deal could bring a second possible U.S. supply of BCG.
The news broke over the weekend. Nasdaq wasn’t open, so the stock stayed flat in regular trading; Monday will bring the reaction, after a tough Friday session for risk assets. The Nasdaq Composite gave up 1.54%. The SPDR S&P Biotech ETF lost 3.08%. ImmunityBio dropped 2.21%.
ImmunityBio shares slipped about 6.3% for the week, dropping from $8.51 on May 8 to $7.97 on May 15. Friday’s trading volume came in at 11.35 million shares, lighter than the week before when activity picked up around earnings.
Japan BCG Laboratory hasn’t launched a product yet. ImmunityBio said it will be the only applicant for a U.S. Biologics License Application and will take the lead in FDA marketing-approval filings for the biologic. The company said the Tokyo strain is still investigational in the U.S. and doesn’t have FDA approval.
ImmunityBio pointed to results from the SWOG S1602 Phase III trial, saying the data showed non-inferiority for Tokyo-172 BCG compared to TICE BCG in patients with BCG-naive high-grade non-muscle invasive bladder cancer. Founder and executive chairman Patrick Soon-Shiong called the study “rigorous, publicly funded science.” ImmunityBio, Inc.
ImmunityBio’s president and CEO Richard Adcock said urologists and patients in the U.S. have dealt with a “chronic BCG shortage for more than a decade.” He said the company is planning to work with the FDA on the regulatory route for the Tokyo strain. Recombinant BCG will still be offered for eligible patients through ImmunityBio’s expanded-access program. ImmunityBio, Inc.
ImmunityBio signed the supply deal after posting sharply higher Anktiva sales but still a deep quarterly loss. The company’s 10-Q showed first-quarter product revenue climbed to $44.2 million, up 168% from the prior year. Net loss attributable to common stockholders was much wider at $632.8 million, mainly because of non-cash fair-value changes in warrants, derivatives and a related-party convertible note.
Adcock said earlier this month the company had “strong demand for ANKTIVA.” Soon-Shiong pointed to progress on filings for bladder cancer and non-small cell lung cancer. The remarks keep the growth story out front, but traders are still pricing the stock as a volatile commercial-stage biotech, not a mature drugmaker. ImmunityBio, Inc.
The competitive set isn’t large. Merck & Co’s Keytruda has an FDA nod for some BCG-unresponsive high-risk non-muscle invasive bladder cancer. Ferring’s Adstiladrin is also FDA-listed for high-grade BCG-unresponsive non-muscle invasive bladder cancer. ImmunityBio is going a different route with Anktiva, which is approved in the U.S. only when used together with BCG.
FDA flags issues with ImmunityBio’s Anktiva ad; company faces funding questions
The risk for ImmunityBio is more than just market swings. In March, the FDA said an Anktiva TV ad and podcast were false or misleading, misbranded the drug, and gave an impression that Anktiva could cure or prevent all cancer. The agency told the company to fix the violations. ImmunityBio also said in its 10-Q filing it expects to need more funding for future operations, including commercialization and development work.
Piper Sandler’s Edward Tenthoff is sticking with his Anktiva sales call, even after the FDA warning letter. He told Reuters he thinks ImmunityBio can meet what the FDA wants and isn’t changing his revenue numbers.
Japan BCG’s deal puts Monday in focus for investors who want to see if this is a real supply move or just another sign that the wait for regulators goes on. Next, traders will watch for new FDA timing headlines. Biotech stocks still move with yields, inflation fears, and risk sentiment, especially in the wake of Friday’s selloff.
