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]

Core Insights - ImmunityBio, Inc. is advancing discussions with the FDA regarding its clinical development pipeline for non-muscle invasive bladder cancer (NMIBC) and non-small cell lung cancer (NSCLC) [1] Group 1: NMIBC BCG Unresponsive Papillary Disease - The company is preparing to submit a supplemental Biologics License Application (sBLA) in 2025 for its treatment targeting BCG unresponsive NMIBC in the papillary indication [4] - The primary endpoint was met with a disease-free rate of 55% at 12 months, 51% at 18 months, and 48% at 24 months, as published in the Chamie 2022 NEJM publication [4] - Patients receiving Anktiva+BCG achieved a 93% avoidance of cystectomy with a median follow-up of 20.7 months [4] Group 2: Alternative Source of BCG - In collaboration with the Serum Institute of India, ImmunityBio plans a regulatory submission for an alternative source of BCG in the first quarter of 2025 [4] - The Serum Institute's GMP capacity to manufacture large-scale volumes of BCG has already been tested for safety and efficacy in clinical trials in Europe for subjects with NMIBC [4] - This initiative aims to address the shortage of BCG [4]

Core Insights - The article discusses ImmunityBio's (NASDAQ: IBRX) commercial strategy and the launch of ANKTIVA for treating BCG-unresponsive non-muscle invasive bladder cancer, highlighting the company's focus on innovative therapies [2]. Company Overview - ImmunityBio is positioned in the biotech sector, focusing on breakthrough therapies and pharmaceuticals, particularly in the oncology space [2]. Investment Strategy - The article emphasizes the importance of a strong commercial strategy and clinical data in driving investment opportunities within the healthcare sector, particularly for companies like ImmunityBio [2].

Group 1 - The article discusses ImmunityBio (NASDAQ: IBRX), highlighting its founder Dr. Patrick Soon-Shiong, who holds approximately 76% of the company's common stock [2] - ImmunityBio has recently received approval for its vaccine-style cancer drug, Anktiva, which is a significant development for the company [2] - The investing group Haggerston BioHealth provides insights for both novice and experienced biotech investors, including catalysts to watch for and buy/sell ratings [2] Group 2 - The article emphasizes the importance of detailed financial models and research available through the Haggerston BioHealth marketplace channel, which includes product sales forecasts for major pharmaceutical companies [2] - The analyst has extensive experience in the biotech, healthcare, and pharma sectors, having compiled detailed reports on over 1,000 companies [2]

Core Viewpoint - ImmunityBio, Inc. has announced a public offering of 33,333,334 shares of common stock at a price of $3.00 per share, aiming to raise approximately $100 million in gross proceeds [1][3]. Group 1: Offering Details - The underwriters have a 30-day option to purchase an additional 5,000,000 shares at the public offering price [1]. - The offering is expected to close on or about December 12, 2024, subject to customary closing conditions [1]. - Jefferies and Piper Sandler are acting as joint book-running managers for the offering, with BTIG and H.C. Wainwright & Co. as co-lead managers [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to advance the commercialization of ANKTIVA® for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) and to fund trials in BCG-naïve NMIBC and non-small cell lung cancer (NSCLC) [3]. - Additional uses include further research and development, working capital needs, and other general corporate purposes [3]. Group 3: Company Overview - ImmunityBio is a biotechnology company focused on developing immunotherapies that enhance the natural immune system to combat cancers and infectious diseases [5]. - ANKTIVA® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS, designed to activate natural killer cells and T cells for a prolonged immune response [5].

Core Insights - ImmunityBio, Inc. and nCartes, Inc. have entered a collaboration to automate and streamline the data fulfillment process for clinical trials, aiming to enhance efficiency and reduce costs for trial investigators [1][2][3] Group 1: Collaboration Details - The collaboration will utilize digital information from electronic medical record (EMR) systems to directly populate Electronic Data Capture (EDC) systems, replacing the traditional manual data entry process [2][3] - This new approach is expected to reduce delays in clinical trials, improve data quality by minimizing entry errors, and lower costs associated with source data verification [3][4] Group 2: Company Profiles - ImmunityBio is a vertically-integrated biotechnology company focused on developing therapies and vaccines that enhance the immune system to combat cancers and infectious diseases, with a notable product being ANKTIVA®, the first FDA-approved immunotherapy for non-muscle invasive bladder cancer [5] - nCartes is a cloud software platform provider that enables clinical research sponsors to automate data capture for clinical trials and other applications, leveraging electronic health systems [4][5]

Core Viewpoint - ImmunityBio (IBRX) shares have increased by 41.1% in the past four weeks, closing at $5.01, with a mean price target of $14.25 suggesting a potential upside of 184.4% [1] Price Targets - The average price target consists of three estimates ranging from a low of $4.75 to a high of $30, with a standard deviation of $13.74, indicating variability among analysts [2] - The lowest estimate suggests a decline of 5.2%, while the highest indicates a potential upside of 498.8% [2] Analyst Sentiment - Analysts show strong agreement on IBRX's ability to report better earnings than previously predicted, which supports the potential for stock upside [4] - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 2.9%, with one estimate moving higher and no negative revisions [10] Zacks Rank - IBRX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, indicating a strong potential upside [11] Earnings Estimate Revisions - There is a strong correlation between trends in earnings estimate revisions and near-term stock price movements, suggesting that the positive revisions could lead to stock price increases [9]

Group 1 - Schubert Jonckheer & Kolbe LLP is investigating potential legal claims related to ImmunityBio, Inc.'s unsuccessful efforts to secure regulatory approval for its product Anktiva, which is intended for bladder cancer treatment [1] - A class action complaint has been filed against ImmunityBio, alleging that the company misled investors about the prospects of obtaining FDA approval for Anktiva by concealing issues related to recordkeeping, quality control, and sanitation at its contract manufacturer [2] - Following the revelation of these issues in May 2023, ImmunityBio's stock experienced a significant decline of 55% [2] Group 2 - The Schubert firm is looking into potential wrongdoing by ImmunityBio's officers and directors in connection with the allegations made in the class action complaint [3] - Current shareholders of ImmunityBio are encouraged to seek additional information regarding their legal rights [3]

ImmunityBio (IBRX) came out with a quarterly loss of $0.14 per share versus the Zacks Consensus Estimate of a loss of $0.18. This compares to loss of $0.19 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 22.22%. A quarter ago, it was expected that this immunotherapy company would post a loss of $0.17 per share when it actually produced a loss of $0.20, delivering a surprise of -17.65%.Over the last four quarters, the company h ...

NEW YORK, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against ImmunityBio, Inc. (NASDAQ: IBRX) on behalf of long-term stockholders following a class action complaint that was filed against ImmunityBio on June 30, 2023 with a Class Period from May 23, 2022 to May 10, 2023. Our investigation concerns whether the board of directors of ImmunityBio have breached their fiduciary duties to the company. Immunit ...