ImmunityBio (NASDAQ: IBRX) wins Saudi accelerated approval for ANKTIVA in two cancer indications

Rhea-AI Filing Summary

ImmunityBio, Inc. reported that the Saudi Food and Drug Authority has granted accelerated approval for its immunotherapy ANKTIVA in two cancer indications. ANKTIVA was approved for use with immune checkpoint inhibitors to treat adult patients with metastatic non-small cell lung cancer whose disease has progressed after standard-of-care therapy. It was also approved in combination with BCG for adult patients with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, with or without papillary disease. The company disclosed these updates through press releases that are furnished as exhibits.

Positive

• Saudi SFDA accelerated approval of ANKTIVA in two adult cancer indications (metastatic NSCLC with checkpoint inhibitors and BCG-unresponsive NMIBC with BCG) expands its regulatory footprint.

Negative

• None.

Insights

Biotech and regulatory analyst

Accelerated Saudi approval for ANKTIVA in two cancer settings.

ImmunityBio received accelerated approval from the Saudi Food and Drug Authority for ANKTIVA in metastatic non-small cell lung cancer and BCG-unresponsive non-muscle invasive bladder cancer. In lung cancer, ANKTIVA is cleared for use with immune checkpoint inhibitors in adults whose disease progressed after standard-of-care treatment. In bladder cancer, it is approved with BCG for carcinoma in situ, with or without papillary disease, in adults who did not respond to prior BCG.

Accelerated approval in two distinct indications signals regulatory recognition of ANKTIVA’s potential clinical role in Saudi Arabia, though commercial uptake will depend on physician adoption and access decisions that are not described here. Future company disclosures may provide details on implementation, such as launch timing, pricing, or any post-approval study requirements associated with the accelerated pathway.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 14, 2026

ImmunityBio, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-37507

43-1979754

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

3530 John Hopkins Court

San Diego, California 92121

(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code: (844) 696-5235

Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

IBRX

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01    Other Events.

On January 14, 2026, ImmunityBio, Inc. (“ImmunityBio” or the “Company”) issued press releases announcing that The Saudi Food and Drug Authority (SFDA) has granted accelerated approval of:

•ANKTIVA® for use in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic non-small cell lung cancer whose disease has progressed following standard-of-care therapy; and

•ANKTIVA® plus Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, with or without papillary disease.

Copies of the press releases are attached hereto as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K and are furnished as Exhibit 99.1 and Exhibit 99.2 hereto.

The information in this Item 8.01, including Exhibit 99.1 and Exhibit 99.2 attached hereto, shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.

Item 9.01    Financial Statements and Exhibits.

(d)Exhibits

Exhibit Number						Description of Exhibit
99.1**						Press release dated January 14, 2026.
99.2**						Press release dated January 14, 2026.
104						Cover Page Interactive Data File (embedded within the Inline XBRL document).

_______________

**    Furnished herewith.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

									IMMUNITYBIO, INC.
									Registrant
Date: January 14, 2026			By:						/s/ David C. Sachs
									David C. Sachs
									Chief Financial Officer

FAQ

What did ImmunityBio (IBRX) announce in this 8-K?

ImmunityBio reported that the Saudi Food and Drug Authority granted accelerated approval of ANKTIVA in combination regimens for two adult cancer indications, and it furnished related press releases as exhibits.

For which lung cancer indication did Saudi regulators approve ANKTIVA?

ANKTIVA received accelerated approval for use with immune checkpoint inhibitors to treat adult patients with metastatic non-small cell lung cancer whose disease has progressed following standard-of-care therapy.

How will ANKTIVA be used in bladder cancer according to the Saudi approval?

The approval covers ANKTIVA plus Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, with or without papillary disease.

Are the ANKTIVA press releases part of this ImmunityBio 8-K?

Yes. The company states that copies of the press releases are attached and furnished as Exhibits 99.1 and 99.2 to the Form 8-K.

Does ImmunityBio treat the ANKTIVA press releases as filed or furnished?

The company specifies that the information in Item 8.01, including Exhibits 99.1 and 99.2, is furnished, not filed, for purposes of liability under Section 18 of the Exchange Act.

Which exhibits are included with this ImmunityBio 8-K?

The 8-K lists Exhibit 99.1 and 99.2 as press releases dated January 14, 2026, and Exhibit 104 as the cover page interactive data file embedded in the Inline XBRL document.