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  • Regulatory Milestone Propels ImmunityBio (IBRX) Stock Upward

    Regulatory Milestone Propels ImmunityBio (IBRX) Stock Upward

    After receiving a significant regulatory approval, ImmunityBio, Inc. (NASDAQ: IBRX) saw a sharp rise in the value of its shares. IBRX shares rose 18.25% to $3.96 as of the most recent market check. In reaction to the FDA’s approval of an Expanded Access Program (EAP) that will enable a different source of Bacillus Calmette-Guérin (BCG), a vital therapy for bladder cancer, the spike has occurred.

    Resolving Serious Deficits in the Treatment of Bladder Cancer

    TICE BCG is the standard-of-care treatment for non-muscle invasive bladder cancer (NMIBC), and the United States has been struggling with ongoing shortages. According to a recent Sermo poll of 100 urologists nationwide, 57% of participants reported having trouble treating patients in the last 12 months as a result of a lack of BCG supplies.

    The treatment efficiently targets malignant cells by inducing an immunological response in the bladder. Supply chain vulnerabilities have been exacerbated by the U.S.’s exclusive reliance on Merck & Co. for domestic manufacture of TICE BCG, despite its extensive use.

    Partnership with the Indian Serum Institute

    ImmunityBio has teamed up with the Serum Institute of India, the biggest vaccine producer in the world by volume, to help alleviate the supply shortage. The goal of this partnership is to present a different source of BCG that has shown encouraging outcomes in clinical studies conducted in Europe.

    Compared to earlier formulations, the recombinant BCG vaccination has demonstrated improved safety and increased immunogenicity, activating both CD8+ and CD4+ T cells.

    Maintaining Constant Access to Essential Medical Care

    The continuous scarcity of necessary medications emphasizes how the biopharmaceutical sector needs to innovate. The move by ImmunityBio, in collaboration with the FDA and the Serum Institute of India, is a big step in ensuring that patients with bladder cancer have a steady supply of BCG.

    Further demonstrating its dedication to developing treatments for bladder cancer, ImmunityBio (IBRX) has also obtained many patents for the combination of BCG and ANKTIVA.

  • ImmunityBio (IBRX) Stock Extends Pre-Hour Rally Following Clinical Trial News

    ImmunityBio (IBRX) Stock Extends Pre-Hour Rally Following Clinical Trial News

    Pre-market trading for ImmunityBio, Inc. (NASDAQ: IBRX) shows a noteworthy continuation of the company’s current rising trend. As of the last check, IBRX stock was increasing by 5.46% during pre-market session to $4.44 after closing at $4.21 the previous day with a significant rise of 21.68%. This spike comes after the first dosage in a clinical trial was announced, which greatly increased investor confidence.

    CAR-NK Cell Therapy Pioneering

    ImmunityBio’s (IBRX) clinical advances are highlighted by the start of a groundbreaking investigation to assess the efficacy of IBRX’s CAR-NK cell therapy, which precisely targets CD-19, for the treatment of non-Hodgkin’s lymphoma (NHL).

    The QUILT 106 trial will examine the efficacy and safety of CD19-targeted high-affinity natural killer (t-haNK) cells. They will be examined first as a monotherapy and then in conjunction with the standard NHL treatment, rituximab. For this phase 1 open-label experiment, up to 10 participants are needed from Johannesburg, Pretoria, and Bloemfontein, South Africa.

    Addressing a Critical Healthcare Need

    Being the first cellular-targeted natural killer (NK) cell treatment research carried out in South Africa, this trial represents an important milestone. Non-Hodgkin’s lymphoma is the sixth most prevalent cancer in Sub-Saharan Africa, the fourth most frequent illness in men, and the fifth most common in women, according to the Cancer Association of South Africa. This investigation may provide important clinical insights given the high diagnostic rates and lack of approved therapies in the area.

    Future Prospects and Implications

    The QUILT 106 trial is pivotal for ImmunityBio, representing its inaugural clinical study of the CAR-NK, CD19 t-haNK cell line and its first investigation into liquid tumors. The company has undertaken this research in response to the often-overlooked Sub-Saharan African populations, highlighting the pressing need for innovative immunotherapies in the area.

    Full patient enrollment for this Phase 1 study is anticipated by the first quarter of 2025, with topline data expected in the latter half of the same year. This study parallels U.S.-based QUILT 3.092 trial of ImmunityBio, reinforcing the company’s commitment to advancing cancer treatment options globally.

  • Navigating Regulatory Hurdles: ImmunityBio (IBRX) Gains Market Traction

    Navigating Regulatory Hurdles: ImmunityBio (IBRX) Gains Market Traction

    The stock of ImmunityBio, Inc. (NASDAQ: IBRX) is experiencing a notable surge, exhibiting a substantial uptick of 7.94% during the current trading session, reaching $5.33. This significant rise in IBRX stock price closely follows the regulatory clearance of one of its pharmaceutical products.

    The FDA has approved ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) in conjunction with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) accompanied by carcinoma in situ (CIS), with or without papillary tumors, ImmunityBio (IBRX) shared yesterday.

    The approval of ANKTIVA by the FDA signals the arrival of a next-generation immunotherapy that will outperform checkpoint drugs. ANKTIVA not only stimulates the proliferation and activation of the patient’s innate NK cells and CD8+ cytotoxic T cells but also triggers CD4+ T helper cells, thereby amplifying the expansion of memory cytotoxic T cells.

    This innovative mode of action, akin to dendritic cell biology, initiates the progression of immunotherapy beyond solely targeting T cells. The amalgamation of enhanced proliferation of crucial anti-cancer immune cells, alongside the activation of memory T cells, culminates in enduring complete responses.

    The ‘triangle offense’ of immune system-mediated tumor cell eradication coupled with sustained memory underscores the cornerstone of endeavors to craft a therapeutic cancer vaccine spanning various tumor types, irrespective of their origin. The complete response rate for the 77 assessable patients stood at 62%, with the upper limit of the confidence interval reaching 73%.

    The persistence of complete response surpassing 47 months as of the November 2023 assessment, and ongoing to date, surpasses the threshold for clinically meaningful outcomes suggested by an expert panel at the IBCG.

    The protracted duration of complete response, exceeding 24 months with ANKTIVA and BCG, heralds a paradigm shift for NMIBC patients, offering compelling clinical evidence of ANKTIVA’s efficacy for individuals historically confronted with high recurrence rates and substantial decline in quality of life due to radical surgical interventions.

    With this endorsement, ANKTIVA may potentially establish a new treatment standard for NMIBC patients, potentially revolutionizing the management of bladder cancer. ANKTIVA is slated to be accessible in the U.S. by mid-May 2024.

  • ImmunityBio, Inc. (IBRX) gained in the after-hours; here is why?

    ImmunityBio, Inc. (IBRX) gained in the after-hours; here is why?

    The stock of ImmunityBio, Inc. (IBRX) gained in the after-hours when the company announced its promising results for its study. IBRX values at around $6.20, gaining more than 6.5% from the previously closed value. The stock closed at $5.82 at the end of the previously closed session. The stock volume traded in the last trading session was around 1.97 million shares.

    IBRX announced clinical study results.

    ImmunityBio, Inc. (IBRX) today announced promising study results. ImmunityBio’s (IBRX) IL-15 superagonist shows to activate CD4+ and CD8+ T cells as well as natural killer (NK) cells in HIV patients (N-803). Anktiva activates latent HIV replication in CD4 memory cells, allowing CD8 and NK cells to detect and kill previously concealed infected cells. This method is critical for killing latent virus-carrying cells, lowering viral reservoirs in ART-suppressed HIV patients, and finally eliminating the virus from the body.

    Three functions of ImmunityBio’s IL-15 superagonist Anktiva shows to aid the immune system to eradicate HIV reservoirs and manage virus rebound:

    • Anktiva demonstrates to reverse HIV latency (where the virus’ genetic code persists, but no virus generates), allowing infected cells to elude identification and destruction by the immune system.
    • It activates NK cells and CD8+ T cells, two immune system components that target virus-infected cells.
    • It allows NK cells and CD8+ T cells to migrate into lymphoid organs, where they are more likely to encounter and kill HIV-infected cells.

    The effect on the stock 

    IBRX stock gained in the after-hours when they announced its results for the clinical study. Investors are responding positively to the significant development in the study. The stock is volatile after-hours, but it may increase more when the regular trading session starts.

    Conclusion

    ImmunityBio, Inc. (IBRX) is now in the later stage of drug development. Those companies that reach the trials’ final stages manage to get the FDA approval. IBRX may also get that approval. Investors are betting on the stock seeing the results.