IBRX Stock Soars on Completing Filing for Cancer Therapy in EU & UK

Regulatory Progress and Approvals - ImmunityBio completed the regulatory filing process in the EU and the UK for Anktiva in combination with BCG to treat BCG-unresponsive NMIBC patients with CIS, with or without papillary tumors [1] - Acceptance of the applications by regulatory bodies in the EU and the UK is expected by Q4 2025, with final decisions anticipated by 2026 [2] - Anktiva, in combination with BCG, received FDA approval in April 2024 for the same indication in the US, and the product is now broadly available through commercial and government insurance programs [3] - The Centers for Medicare & Medicaid Services assigned a unique, permanent HCPCS J-code for Anktiva, simplifying reimbursement and increasing accessibility for over 240 million lives covered by insurance plans [4] Clinical Data and Pipeline Updates - ImmunityBio is preparing to submit a supplemental BLA in 2025 for Anktiva + BCG to treat BCG-unresponsive NMIBC in the papillary indication, with clinical data showing disease-free rates of 55% at 12 months, 51% at 18 months, and 48% at 24 months [8] - 93% of patients avoided cystectomy after a median follow-up of 20.7 months [8] - The company plans to submit a BLA for Anktiva as a monotherapy for second and third-line treatment of NSCLC patients progressing on checkpoint inhibitors, supported by mid-stage QUILT-3.055 study results showing median overall survival of 14.1 months for all patients and 15.8 months for PD-L1 negative patients [10] - Anktiva is being evaluated as a monotherapy or in combination with other agents for various cancer indications in separate clinical studies [11] Stock Performance and Industry Comparison - ImmunityBio shares rallied 27.2% following the regulatory filing announcement [1] - Over the past three months, ImmunityBio shares have lost 14.4%, compared to the industry's 12.2% decline [5] - The stock price rise was also fueled by substantial progress in ongoing discussions with the FDA regarding NMIBC and NSCLC pipeline programs [6] Competitor Analysis - Castle Biosciences (CSTL) has seen its 2024 earnings estimates remain constant at 34 cents per share, with a 23.2% share price decline over the past three months [13] - CytomX Therapeutics (CTMX) has maintained 2024 loss per share estimates at 5 cents, with shares losing 28.2% over the past three months [14] - BioMarin Pharmaceutical (BMRN) has seen 2024 earnings per share estimates improve from $3.28 to $3.29, with shares losing 12.6% over the past three months [15]