ImmunityBio, Inc.

1 products tracked · names used in filings: ImmunityBio, Inc., Immunitybio Ireland Limited

Upcoming milestones

Wed 06 Jan 2027🇺🇸 PDUFA datecompany-announcedin 53 days

ANKTIVA: PDUFA target action date (BCG-unresponsive NMIBC with papillary disease without CIS (ANKTIVA plus BCG))

ImmunityBio, Inc. (IBRX); sBLA; status: set; "…The FDA accepted for review the Company’s supplemental Biologics License Application (sBLA) for ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC with papillary disease without CIS and assigned a PDUFA target action date of January 6, 2027 • Continued advancement across the clinical pipeline, with multiple…"; filed 2026-08-04 · source

Recent milestones

Mon 16 Feb 2026🇪🇺 EU approval (EC decision)

Anktiva (nogapendekin alfa inbakicept) approved in the EU

Marketing authorisation to Immunitybio Ireland Limited; Conditional, Additional monitoring · source

Thu 11 Dec 2025🇪🇺 CHMP positive opinion

Anktiva (nogapendekin alfa inbakicept): CHMP positive opinion

Immunitybio Ireland Limited; Conditional, Additional monitoring · source

Products

	Product	Status	Approved
🇪🇺	Anktiva nogapendekin alfa inbakicept	Authorised	2026-02-16

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.