ImmunityBio

ImmunityBio shares climbed 7.5% after ANKTIVA was approved in the United Arab Emirates. The approval covers ANKTIVA 0.4 mg in combination with BCG for the treatment of adult patients with BCG-unresponsive, non‑muscle‑invasive bladder cancer and ANKTIVA 1.2 mg with immune checkpoint inhibitors for metastatic non‑small‑cell lung cancer. The approval expands ANKTIVA’s regulatory presence to 34 countries and is based on the QUILT‑3.032 study (in NMIBC: 71% complete response rate in the CIS cohort; 12‑month DFR 58.2% in papillary tumors; 83% cystectomy‑free at 36 months) and QUILT‑3.055 (in checkpoint‑refractory NSCLC: median overall survival 14.6 months). » More on de.investing.com

A health economic analysis presented in Philadelphia shows that ANKTIVA combined with BCG achieves substantial cost savings over three years compared with TAR-200 for BCG-unresponsive, non–muscle-invasive bladder cancer. Savings per avoided cystectomy were $109,622 in year 1, $151,438 in year 2 and $60,393 in year 3; savings per cystectomy-free month were $9,370, $6,144 and $1,520 in years 1–3, respectively. The study attributed the cost reductions to lower acquisition and administration costs and slightly higher complete response rates (49.6% vs. 45.9%). Investors reacted positively; the stock has returned 272% in the past six months and is trading at $7.74. » More on de.investing.com

ImmunityBio has signed an exclusive development and supply agreement with Japan BCG Laboratory for the Tokio-172 BCG strain in the U.S. and could become the sole BLA applicant. The decision is based on Phase III SWOG S1602 data showing non-inferiority to TICE BCG (HR 0.82) and an estimated 5-year recurrence-free survival of 64% vs. 58%. Tokio-172 is not yet FDA-approved in the U.S.; ImmunityBio is in discussions with the FDA and research institutions about data use and plans regulatory steps. The company reports strong revenue growth but remains unprofitable, and analysts see further upside potential despite recent share gains. » More on de.investing.com