ImmunityBio, Inc. 8-K

What Happened

• On January 14, 2026 ImmunityBio, Inc. (IBRX) announced that the Saudi Food and Drug Authority (SFDA) has granted accelerated approval for ANKTIVA® for two indications in Saudi Arabia: (1) in combination with immune checkpoint inhibitors for adult patients with metastatic non‑small cell lung cancer (NSCLC) whose disease progressed after standard‑of‑care therapy; and (2) 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). The company furnished related press releases as exhibits to the Form 8‑K.

Key Details

• Date of filing/announcement: January 14, 2026.
• Regulator: Saudi Food and Drug Authority (SFDA) – granted accelerated approvals.
• Indications approved: metastatic NSCLC (in combination with immune checkpoint inhibitors) and BCG‑unresponsive non‑muscle invasive bladder cancer (ANKTIVA + BCG).
• Press releases attached to the 8‑K as Exhibits 99.1 and 99.2.

Why It Matters

• These SFDA accelerated approvals are regulatory milestones for ImmunityBio in Saudi Arabia for ANKTIVA. Regulatory approvals can expand the company’s market access in a new geography and are important steps toward potential commercialization and patient access in that country. Investors should view this as a product‑level regulatory advancement; any commercial impact will depend on subsequent market launch, pricing, reimbursement and broader regulatory status in other markets.