NEW YORK, May 18, 2026, 09:06 (EDT)
ImmunityBio shares were active before the Nasdaq bell on Monday after the company said five U.S. patents will protect its Anktiva-plus-BCG bladder cancer treatment into at least 2035. This statement followed Friday’s announcement of an exclusive U.S. supply deal with Japan BCG Laboratory. The stock last traded at $7.97, unchanged from Friday’s close, when it slipped 2.2% on volume of 11.3 million shares.
Nasdaq regular trading hadn’t started yet. The exchange’s posted hours run 9:30 a.m. to 4 p.m. Eastern, with pre-market trading open 4 a.m. to 9:30 a.m. Memorial Day, May 25, is the next scheduled U.S. market holiday in 2026.
ImmunityBio is pushing to expand Anktiva from its approved use in bladder cancer and cut its BCG supply risk, making timing key. BCG, or Bacillus Calmette-Guérin, is a live bacteria immunotherapy used inside the bladder for certain bladder cancers.
ImmunityBio said Saturday it secured exclusive U.S. rights to develop, import, and commercialize Tokyo-172 BCG from Japan BCG Laboratory. The company said it plans to work with the FDA on a regulatory path as the sole Biologics License Application applicant. A BLA is the filing used to seek FDA approval for a biologic drug. The Tokyo strain is still investigational in the U.S. and not approved by the FDA.
Japan BCG Laboratory President Seiichi Inoue said the company was “pleased to partner” with ImmunityBio. ImmunityBio CEO Richard Adcock said the deal offers a “second potential BCG source” for the U.S. ImmunityBio also pointed to Phase III SWOG S1602 data showing Tokyo-172 BCG was non-inferior to TICE BCG, meaning the trial was meant to show it was not worse by more than a preset amount. ImmunityBio
ImmunityBio’s patent news on Monday brings something new. The company said the patents cover how to treat non-muscle invasive bladder cancer, or NMIBC, plus compositions and two-vial kits for combining Anktiva with BCG. NMIBC means bladder cancer that hasn’t reached the muscle wall. Founder and Executive Chairman Patrick Soon-Shiong called the drug pairing the “backbone of our bladder cancer franchise.” ImmunityBio
Anktiva, known generically as nogapendekin alfa inbakicept-pmln, won FDA approval in April 2024. The drug is cleared for use with BCG in adults with BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumors. Carcinoma in situ is described as a flat, high-risk cancer on the bladder lining. The data used for the FDA nod showed a 62% complete response rate. Of those patients who responded, 58% kept their response for at least 12 months.
Merck’s Keytruda is already cleared for some patients with BCG-unresponsive, high-risk NMIBC who can’t or won’t have cystectomy. Ferring’s Adstiladrin is also listed by the FDA for high-grade BCG-unresponsive NMIBC. The competitive field here is tight but active. The Japan BCG deal looks more like a move on supply and positioning than a straight drug-to-drug matchup.
ImmunityBio posted new numbers for investors. On May 7, the company said first-quarter net product revenue jumped 168% from a year earlier to $44.2 million. At March 31, ImmunityBio had $380.9 million in cash, cash equivalents and marketable securities. Net loss for the quarter came in at $632.8 million, mostly from non-cash fair-value changes. The adjusted net loss was $86.2 million. Adjusted results exclude some items and are non-GAAP.
But risks are still clear. The FDA might not sign off on Tokyo-172 BCG or new supplements, ImmunityBio patents could face challenges or be worked around, and the company is still dealing with a March warning from the FDA over how it promoted Anktiva. Piper Sandler’s Edward Tenthoff told Reuters then, “we believe ImmunityBio can comply,” but that warning means regulatory messaging risk isn’t gone. ImmunityBio
Stock-index futures in the U.S. slipped early Monday. Treasury yields and oil prices went up, raising concerns among investors that inflation could leave borrowing costs elevated. “Higher yields can weigh on equity valuations,” eToro global market strategist Lale Akoner told Reuters. That’s particularly relevant to biotech firms with big spending on trials and commercialization. Reuters
ImmunityBio faces new challenges, with the focus now on whether it can use its patents and possible BCG supply to move forward on the regulatory front and keep Anktiva sales more stable. The company said it will have future updates on the Tokyo strain’s U.S. regulatory route, including talks with the FDA and any BLA timing.
