Latest news with #bladdercancer
Yahoo
a day ago
- Business
- Yahoo
ImmunityBio's (IBRX) ANKTIVA Gets Approved by UK's Medicines and Healthcare Regulatory Agency
ImmunityBio, Inc. (NASDAQ:IBRX) is one of the . On July 8, ImmunityBio, Inc. (NASDAQ:IBRX) announced that the UK's Medicines and Healthcare products Regulatory Agency has approved ANKTIVA with Bacillus Calmette-Guérin for treating certain bladder cancer patients. This is significant as it marks the first approval for the company outside of the United States of America. Moreover, the drug is a first-in-class IL-15 agonist, which works by activating and multiplying immune cells, specifically NK cells and T cells that help the body fight cancer. A technician analyzing natural killer cells, as part of an immune system study and research into therapeutical agents. In addition, clinical studies have shown strong results as some patients maintained a complete response for over 47 months at the last review. ImmunityBio, Inc. (NASDAQ:IBRX) is a biopharmaceutical company that develops therapies and vaccines that boost the immune system to fight cancer and infectious diseases. While we acknowledge the potential of IBRX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Medscape
16-07-2025
- Health
- Medscape
Fact or Fiction: Bladder Cancer
Recent advances in immunotherapy, genomic profiling, and bladder-sparing techniques have begun to reshape diagnostic algorithms and treatment strategies across disease stages, from non-muscle-invasive to metastatic bladder cancer. Immunotherapies targeting PD-1 and PD-L1 have shown durable responses in certain subsets of patients, while next-generation sequencing helps guide decisions by identifying actionable mutations and molecular subtypes. Additionally, minimally invasive surgical techniques, improvements in intravesical therapies, and novel surveillance tools such as urinary biomarkers contribute to a more personalized, risk-adapted approach. As the field moves toward more integrated, multidisciplinary care, clinicians and care teams must stay abreast of these innovations to ensure optimal outcomes, improved quality of life, and equitable access to cutting-edge therapies. Checkpoint inhibitors such as atezolizumab, nivolumab, and pembrolizumab have been approved for patients with advanced or metastatic urothelial carcinoma, especially those ineligible for cisplatin-based chemotherapy or with disease progression after platinum therapy. These agents work by targeting PD-1 or PD-L1 pathways to enhance the immune system's ability to fight cancer. In recent years, nivolumab was approved for use in combination with cisplatin and gemcitabine as first-line treatment for unresectable or metastatic urothelial carcinoma, marking a major shift toward integrating immunotherapy earlier in treatment algorithms. Learn more about immunotherapy for bladder cancer. Cigarette smoking is the leading risk factor for bladder cancer, responsible for approximately 50% of all cases. Smokers are twice as likely to develop bladder cancer than nonsmokers. Smoking cessation significantly reduces risk over time, though former smokers remain at elevated risk compared to never-smokers. Occupational exposures, such as to benzidine and beta-naphthylamine, are also important, especially for long-term workers in underregulated environments. However, these exposures account for a smaller percentage of overall cases. Environmental exposures are increasingly being realized as a cause for bladder cancer. Pesticides and contaminated drinking water are concerns. Learn more about bladder cancer etiology. The majority of NMIBC cases are managed conservatively, starting with transurethral resection of bladder tumor (TURBT). At recurrence, however, intravesical therapy with instilled chemotherapy drugs, Bacillus Calmette-Guérin (BCG), and immediate radical cystectomy are options that should be discussed. Radical cystectomy is generally reserved for patients who are unresponsive to or who have high-grade T1 lesions with associated carcinoma in situ, lymphovascular invasion, or variant histology. Bladder preservation is a cornerstone of treatment for low- and intermediate-risk patients with NMIBC, aiming to maintain quality of life while achieving cancer control. Surveillance through periodic cystoscopy and urinary cytology is essential to detect recurrences, which are common. Learn more about treatment for NMIBC. Although several urinary biomarkers (eg, NMP22, UroVysion FISH, Cxbladder, bladder tumor antigen tests) are available, they have not replaced cystoscopy, which remains the cornerstone of surveillance. Cystoscopy provides direct visualization and allows for resection of visible tumors, whereas biomarkers have variable sensitivity and specificity with the potential for false positives. Urinary biomarkers are being incorporated as adjuncts to traditional surveillance, however, as they offer minimal discomfort and invasiveness for patients. Ongoing research is exploring novel biomarker panels and genomic assays to better personalize surveillance regimens and reduce the burden of routine cystoscopy without compromising oncologic safety. Learn more about long-term monitoring for bladder cancer. Neoadjuvant cisplatin-based chemotherapy, typically gemcitabine plus cisplatin (GC) or methotrexate-vinblastine-doxorubicin-cisplatin (MVAC), has been shown to improve overall survival, with some studies finding a 10% benefit in 5-year survival. As a result, neoadjuvant chemotherapy is considered a standard of care for eligible patients with muscle-invasive bladder cancer. For cisplatin-ineligible patients, ongoing trials are evaluating alternative treatment options in the neoadjuvant setting. Molecular subtyping, while there is not yet currently sufficient evidence to be the standard of care, may help to inform treatment decision-making and offer the potential for more targeted therapies. Learn more about neoadjuvant therapy for bladder cancer.
Yahoo
08-07-2025
- Business
- Yahoo
Tyra Biosciences Doses First Patient in Phase 2 Study of TYRA-300 in Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302)
-TYRA-300 is the only orally administered investigational agent in clinical development for IR NMIBC- -Initial 3-month complete response (CR) data expected to be reported in 1H 2026- CARLSBAD, Calif., June 30, 2025 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, announced today that the first patient has been dosed in the Phase 2 SURF302 clinical trial of TYRA-300 in low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC). TYRA-300 is a potential first-in-class, investigational, oral, FGFR3-selective inhibitor designed to minimize the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for FGFR3 gatekeeper mutations. FGFR3 is a frequently altered gene in IR NMIBC, with ~70% of low-grade IR NMIBC showing activating mutations. "Our goal is to develop TYRA-300 as the first once-daily oral treatment designed to reduce disease recurrence, as well as surgical procedural intervention and intravesical therapy, for people living with IR NMIBC," said Dr. Erik Goluboff, SVP of Clinical Development at TYRA. "We believe we are well-positioned to contribute meaningful advancements to the field of bladder cancer with SURF302, and we anticipate that the clinical data will offer valuable insights with the potential to enhance patient outcomes." SURF302 (NCT06995677) is an open-label Phase 2 clinical study evaluating the efficacy and safety of TYRA-300 in participants with FGFR3-altered low-grade, IR NMIBC. The study will enroll up to 90 participants at multiple sites primarily in the United States. Participants will be randomized initially to treatment with TYRA-300 at 50 mg once daily (QD) (Cohort 1) or treatment with TYRA-300 at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated. The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, the median duration of response, recurrence free survival (RFS), progression free survival (PFS), safety and tolerability. "I am excited that the Phase 2 trial evaluating oral TYRA-300 in IR NMIBC is now underway," said Dr. Tom Jayram, Director of the Advanced Therapeutics Center at Urology Associates in Nashville, TN. "IR NMIBC is a challenging disease for urologists and patients alike, with the potential for recurrence, progression, and the morbidity of multiple procedures for disease surveillance. Selective FGFR inhibitors are an exciting new option in this disease space that can allow a personalized approach to bladder cancer. TYRA-300 is an investigational, daily oral tablet that has shown encouraging preliminary safety and efficacy in an early phase trial and has the potential to be a paradigm shift in how urologists can treat bladder cancer." TYRA-300 will also be evaluated in pediatric achondroplasia in the BEACH301 Phase 2 study, which is open for enrollment and for which the Company now expects first child dosing in the second half of the year. About Non-Muscle Invasive Bladder Cancer In the United States, it is estimated that there are more than 730,000 people living with bladder cancer. Many of these patients have intermediate risk non-muscle invasive bladder cancer (IR NMIBC) and experience recurrence episodes throughout the course of their disease. Treatment for IR NMIBC and disease recurrence is a surgical procedure called transurethral resection of bladder tumor (TURBT) combined with intravesical-administered chemotherapy. Repeat TURBT procedures and intravesical-administered chemotherapy can impact patients' quality of life and overall health, leading to a significant unmet medical need for better tolerated therapeutic options. TYRA-300 is the only orally administered investigational agent in clinical development for IR NMIBC. About TYRA-300 TYRA-300 is the Company's lead precision medicine program stemming from its in-house SNÅP platform. TYRA-300 is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasia that has demonstrated interim clinical proof-of-concept results in metastatic urothelial cancer (mUC). TYRA-300's planned clinical development includes three Phase 2 clinical trials: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia and SURF301 for mUC. Please visit the Patients page of our website for more information on our clinical trials. About Tyra Biosciences Tyra Biosciences, Inc. (Nasdaq: TYRA) is a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in FGFR biology. The Company's in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies. TYRA's expertise in FGFR biology has created a differentiated pipeline with three clinical-stage programs in targeted oncology and genetically defined conditions. The Company's lead precision medicine stemming from SNÅP, TYRA-300, is a potential first-in-class selective FGFR3 inhibitor that is designed to avoid the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for FGFR3 gatekeeper mutations. TYRA-300's planned clinical development includes three Phase 2 studies: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia and SURF301 for metastatic urothelial cancer. TYRA is also developing TYRA-200, an oral, investigational, FGFR1/2/3 inhibitor, in the SURF201 study for metastatic intrahepatic cholangiocarcinoma, and TYRA-430, an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. TYRA is based in Carlsbad, CA. For more information about our science, pipeline and people, please visit and engage with us on LinkedIn. Forward-Looking Statements TYRA cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: expected reporting of data from the SURF302 study and the timing thereof; the design and goals of the SURF302 study; the potential to develop next-generation precision medicines and for TYRA-300 to be a first-in-class, once-daily oral treatment, and the potential safety and therapeutic benefits of TYRA-300; the expected timing and phase of development of TYRA-300, including the expected timing of dosing for the BEACH301 study in pediatric achondroplasia; and the potential for SNÅP to develop therapies. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: potential delays in the commencement, recruitment, enrollment, data readouts and completion of clinical trials and preclinical studies; results from preclinical studies or early clinical trials not necessarily being predictive of future results; interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient or final data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the potential for proof-of-concept results to fail to result in successful subsequent development of TYRA-300; later developments with the FDA may be inconsistent with prior feedback from the FDA; we are early in our development efforts, and the approach we are taking to discover and develop drugs based on our SNÅP platform is novel and unproven and it may never lead to product candidates that are successful in clinical development or approved products of commercial value; our dependence on third parties in connection with manufacturing, research and preclinical testing; acceptance by the FDA of INDs or of similar regulatory submissions by comparable foreign regulatory authorities for the conduct of clinical trials of our product candidates; an accelerated development or approval pathway may not be available for TYRA-300 or other product candidates and any such pathway may not lead to a faster development process; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; unfavorable results from preclinical studies; regulatory developments in the United States and foreign countries; our ability to obtain and maintain intellectual property protection for our product candidates and proprietary technologies; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact:Amy Conrad aconrad@ View original content to download multimedia: SOURCE Tyra Biosciences Sign in to access your portfolio
Yahoo
08-07-2025
- Business
- Yahoo
UK MHRA Approves ImmunityBio's ANKTIVA® Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ
ANKTIVA, a first-in-class, lymphocyte-stimulating agent, works synergistically with BCG to activate and proliferate natural killer (NK) and T cells, helping eliminate cancer Already approved in the U.S. and designated as a Breakthrough Therapy by the FDA, this marks ANKTIVA's first marketing approval outside the U.S. ANKTIVA plus BCG offers a new option for eligible patients among the 16,400 to 18,000 people diagnosed with NMIBC in the UK each year1 CULVER CITY, Calif., July 08, 2025--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX) today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of certain bladder cancer patients. This is the first marketing approval outside the U.S. for this novel lymphocyte-stimulating agent. "With the MHRA's authorization of ANKTIVA plus BCG, we can now offer our immunotherapy outside the U.S. to help patients with a disease that, if not effectively treated, can lead to bladder removal," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "This immune-boosting, lymphocyte-stimulating agent, the first of its kind, is central to our Cancer BioShield platform, which is designed to restore immune function and support long-term disease control." "ImmunityBio is honored to have received this important authorization from the UK MHRA. In light of the United States Most-Favored-Nation Prescription Drug Pricing policy implemented on May 12, 2025, we are actively evaluating our go-to-market strategy for the UK," said Richard Adcock, CEO and President of ImmunityBio. ANKTIVA is a first-in-class IL-15 agonist that activates and proliferates natural killer (NK) cells and CD4+ and CD8+ T cells. It is designed to restore immune competence by reversing lymphopenia—a condition in which cancer and conventional therapies, such as chemotherapy, radiation and checkpoint inhibitors, reduce the number and function of immune cells. Restoring immune function is essential for immunosurveillance, immunogenic cell death, and sustained tumor control. The BioShield platform's effectiveness can be monitored using a routine complete blood count (CBC). ANKTIVA was designated a Breakthrough Therapy by the FDA and received approval from both the FDA and MHRA based on its safety and efficacy outcomes of complete response (CR) and duration of response (DOR). In a single-arm, multicenter trial, 77 evaluable patients received ANKTIVA with BCG for up to 37 months. As of the November 2023 data cutoff, the duration of complete response for some patients exceeded 47 months and remains ongoing. These extended duration of complete responses beyond 24 months with ANKTIVA and BCG surpasses the benchmark for meaningful clinical results set by experts from the International Bladder Cancer Group. ImmunityBio has also submitted regulatory applications to the European Medicines Agency (EMA) to expand availability of ANKTIVA across the 27 European Union (EU) member states, as well as Iceland, Norway and Liechtenstein. About NMIBC CIS Bladder cancer is the 10th most commonly-diagnosed cancer globally,2 and in the UK, the Action Bladder Cancer UK estimates approximately 23,000 patients are diagnosed annually.1 At the time of diagnosis, about 80% of cases are non-muscle invasive bladder cancer (NMIBC), wherein the cancer is found only on the inner layer of the bladder wall.3 The standard therapy for NMIBC is intravesical instillation (delivery to the bladder via a catheter) of Bacillus Calmette-Guerin (BCG).4,5 BCG is a benign bacteria that induces an immune response in the bladder in proximity to the cancer cells, leading to clearance of the cancer in many patients. In ~30-40% of patients, however, BCG will fail, and in ~50% that initially respond, cancer will recur.6 About ANKTIVA The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo. ANKTIVA was approved by the FDA in 2024 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit INDICATION AND IMPORTANT SAFETY INFORMATION FROM THE FDA LABEL INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle invasive or metastatic bladder cancer, which can be lethal. If patient with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For lntravesical Use Only. Do not administer by subcutaneous or intravenous routes. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours. USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ADVERSE REACTIONS: The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills and pyrexia. For more information about ANKTIVA, please see the Full Prescribing Information at You are encouraged to report negative side effects of prescription drugs to FDA. Visit or call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482) About ImmunityBio ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The Company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates natural killer cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit (Founder's Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram. References: Action Bladder UK. Non-muscle invasive bladder cancer. May 2021. Available at: World Cancer Research Fund. Bladder Cancer Statistics. 2022. Available at: Aldousari S, Kassouf W. Update on the management of non-muscle invasive bladder cancer. Canadian Urological Association Journal, 4(1), 56–64. Holzbeierlein J, Bixler BR, Buckley DI, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline: 2024 amendment. J Urol. 2024;10.1097/JU.0000000000003846. Grabe-Heyne, et al. Intermediate and high-risk non-muscle-invasive bladder cancer: an overview of epidemiology, burden, and unmet needs. Front Oncol. 2023 Jun 2;13:1170124. doi: 10.3389/fonc.2023.1170124. Kodera A, Mohammed M, Lim P, Abdalla O, Elhadi M. The Management of Bacillus Calmette-Guérin (BCG) Failure in High-Risk Non-muscle Invasive Bladder Cancer: A Review Article. Cureus. 2023 Jun 26;15(6):e40962. doi: 10.7759/cureus.40962. PMID: 37503461; PMCID: PMC10369196. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding clinical trial data and potential results and implications to be drawn therefrom, the belief that the MHRA authorization leads to increased revenue, the expectation that the EAP as previously reported will enable access to ANKTIVA for patients across all solid tumor types who have exhausted first-line therapy including chemo, radiation or immunotherapy, the RMAT designation as previously reported and potential results therefrom and regulatory submissions in connection therewith, the belief that ALC levels and NLR levels obtained from a CBC are predictors of clinical benefit and outcomes relating to overall survival, the belief that improving ALC levels and NLR levels correlates with enhanced overall survival and clinical benefit, the belief that reversal of lymphopenia correlates with improved survival, clinical trial and expanded access program enrollment, data and potential results to be drawn therefrom, anticipated components of ImmunityBio's Cancer BioShield platform, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA alone or in combination with other therapeutic agents for the prevention or reversal of lymphopenia, potential future uses and applications of ANKTIVA alone or in combination with other therapeutic agents across multiple tumor types and indications and for potential applications beyond oncology, potential regulatory pathways and the regulatory review process and timing thereof, the application of the Company's science and platforms to treat cancers or develop cancer vaccines, immunotherapies and cell therapies that has the potential to change the paradigm in cancer care, and ImmunityBio's approved product and investigational agents as compared to existing treatment options, and the impact of the MHRA on the Company's ex-United States go to market strategy, including in light of the recently implemented United States Most Favored Nation pricing policy on the Company's go-to-market strategy in the United Kingdom, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as "anticipates," "believes," "continues," "goal," "could," "estimates," "scheduled," "expects," "intends," "may," "plans," "potential," "predicts," "indicate," "projects," "is," "seeks," "should," "will," "strategy," and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio's management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio's statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding the FDA regulatory submission, filing and review process and the timing thereof, (ii) risks and uncertainties regarding regulatory submissions in foreign jurisdictions, filing and review process and the timing thereof, (iii) whether the RMAT designation will lead to an accelerated review or approval, of which there can be no assurance, (iv) risks and uncertainties regarding commercial launch execution, success and timing, (v) risks and uncertainties regarding participation and enrollment and potential results from the expanded access clinical investigation program described herein, (vi) whether clinical trials will result in registrational pathways and the risks, (vii) whether clinical trial data will be accepted by regulatory agencies, (viii) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (iv) potential delays in product availability and regulatory approvals, (x) ImmunityBio's ability to retain and hire key personnel, (xi) ImmunityBio's ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xii) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xiii) ImmunityBio's ability to successfully commercialize its approved product and product candidates, (xiv) ImmunityBio's ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xv) ImmunityBio's ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio's business are described under the heading "Risk Factors" in the Company's Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 3, 2025, and the Company's Form 10-Q filed with the SEC on May 12, 2025, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website at ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. View source version on Contacts ImmunityBio Contacts: Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 Media Sarah Singleton ImmunityBio, Inc. +1 Sign in to access your portfolio
Yahoo
07-07-2025
- Business
- Yahoo
UroGen Pharma Receives FDA Approval for ZUSDURI for Recurrent Bladder Cancer
UroGen Pharma Ltd. (NASDAQ:URGN) is one of the best hot stocks to buy according to Wall Street analysts. In mid-June, UroGen Pharma announced that the US FDA had approved ZUSDURI (mitomycin) for intravesical solution. This marked ZUSDURI as the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ZUSDURI was formerly known as UGN-102 and is an innovative drug formulation of mitomycin combined with a sterile hydrogel, using UroGen's proprietary sustained-release RTGel technology. This design allows for potent tumor ablation through non-surgical means, delivered directly into the bladder via a urinary catheter in an outpatient procedure by a trained healthcare professional. A scientist examining a sample of hydrogel in a laboratory setting. The approval is supported by positive results from the pivotal Phase 3 ENVISION trial. The trial demonstrated that 78% of patients achieved a complete response at 3 months. Furthermore, 79% of those responders maintained their complete response at 12 months after the 3-month visit. The medication exhibited a manageable safety profile as well. UroGen Pharma Ltd. (NASDAQ:URGN) develops and commercializes solutions for urothelial and specialty cancers. While we acknowledge the potential of URGN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
