DelveInsight’s, “Non Muscle Invasive Bladder Cancer Pipeline Insight 2026” report provides comprehensive insights about 20+ companies and 22+ pipeline drugs in the Non Muscle Invasive Bladder Cancer pipeline landscape. It covers the Non Muscle Invasive Bladder Cancer pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Non Muscle Invasive Bladder Cancer pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Curious about the latest updates in the NMIBC Pipeline? Click here to explore the therapies and trials making headlines @ NMIBC Pipeline Outlook Report

Key Takeaways from the NMIBC Pipeline Report

• On March 24, 2026- Merck Sharp & Dohme LLC announced a phase 2 study are to learn if people who receive V940 with BCG live longer and without the cancer growing, spreading, or coming back compared to people who receive BCG alone. The standard treatment for HR NMIBC is a procedure to remove the tumor called transurethral resection of the bladder tumor (TURBT) followed by Bacillus Calmette-Guerin (BCG). Standard treatment is something that is considered the first line of treatment for a condition. BCG is an immunotherapy, which is a treatment that helps the immune system fight cancer.
• On March 20, 2026- ImmunityBio Inc. initiated a Phase Ib/IIb study includes a dose escalation phase (phase Ib) and an expansion phase (phase IIb). In the phase Ib, patients will be treated with intravesical N-803 in combination with BCG. The purpose of the phase Ib portion of the study is to evaluate the safety, identify the Maximum Tolerated Dose (MTD) of N-803 and determine the Recommended Dose (RD) level of N-803 in combination with BCG for the phase IIb expansion.
• On March 20, 2026- Verity Pharmaceuticals Inc. conducted a study is to evaluate the effect of Verity-BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) and to compare our findings to the standard of care BCG formulation, OncoTICE (BCG) in order to examine our hypothesis that Verity-BCG is at least non-inferior to OncoTICE in achieving 24-month Recurrence Free Survival in NMIBC patients who are at high risk of recurrence and have never been treated with intradermal or intravesical BCG before, with the exception of tuberculosis vaccination in childhood.
• On March 19, 2026- Tyra Biosciences Inc. conducted a phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer.
• On March 18, 2026- Ferring Pharmaceuticals initiated a phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC).
• On March 17, 2026- Janssen Research & Development LLC announced a phase 3 study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator’s choice of single agent intravesical chemotherapy.
• On March 16, 2026- CG Oncology Inc. announced a Phase 3, open-label, single arm trial designed to evaluate Cretostimogene patients with NMIBC who have failed prior BCG therapy. Up to approximately 115 CIS bladder cancer patients with or without HG Ta or HG T1 papillary disease will be enrolled under the original protocol through Amendment 4, which will comprise Cohort C. Cohort C is closed to enrollment.
• DelveInsight’s Non Muscle Invasive Bladder Cancer pipeline report depicts a robust space with 20+ active players working to develop 22+ pipeline therapies for Non Muscle Invasive Bladder Cancer treatment.
• The leading Non Muscle Invasive Bladder Cancer Companies such as CG Oncology, Janssen Research & Development, LLC, Tyra Biosciences, Inc, UroGen Pharma Ltd., Prokarium Ltd, Protara Therapeutics, ImmVira Pharma Co. Ltd, Trigone Pharma Ltd., Hoffmann-La Roche, Aura Biosciences, enGene Holdings Inc., Atonco Pharma and others.
• Promising Non Muscle Invasive Bladder Cancer Therapies such as PF-06801591, Bacillus Calmette-Guerin, CG0070, Gemcitabine, APL-1202 treatment, Durvalumab, eRapa, Epirubicin Hydrochloride, Cabazitaxel, Gemcitabine, Cisplatin and others.

Want to know which companies are leading innovation in Non-Muscle Invasive Bladder Cancer? Dive into the full pipeline insights @ NMIBC Clinical Trials Assessment

The NMIBC Pipeline Report provides disease overview, pipeline scenario and therapeutic assessment of the key pipeline therapies in this domain. The NMIBC Pipeline Report also highlights the unmet needs with respect to the development of Non Muscle Invasive Bladder Cancer.

NMIBC Overview

Non-muscle invasive bladder cancer (NMIBC) is cancer found in the tissue that lines the inner surface of the bladder. The bladder muscle is not involved. Bladder cancer is the 6th most common cancer in the United States. Nearly 81,000 people will be diagnosed in the United States with bladder cancer in 2020. Bladder cancer is more common in males than females.

Non Muscle Invasive Bladder Cancer Emerging Drugs Profile

• Cretostimogene grenadenorepvec: CG Oncology

Cretostimogene grenadenorepvec is an oncolytic immunotherapy with a dual mechanism of action that selectively replicates in and lyses cancer cells while simultaneously amplifying the immune response against bladder tumors. Cretostimogene enters the tumor by binding to Coxsackievirus and Adenovirus Receptors (CAR) and integrin αvβ5present in specialized intracellular junctions and tight junctions of polarized epithelial cells. There are two modifications made to cretostimogene for tumor selectivity and potency. The first modification is the insertion of an E2F-1 promoter in cretostimogene which acts as a safety mechanism to selectively replicate and lyse Rb-E2F altered tumor cells rather than healthy cells which have intact Rb-E2F pathways. The second modification is the insertion of the gene for the cytokine granulocyte-macrophage colony stimulation factor (GM-CSF).

• TAR-210: Janssen Research & Development, LLC

TAR‑210 is an innovative intravesical targeted drug delivery system designed for patients with non–muscle-invasive bladder cancer (NMIBC) harboring FGFR alterations. The therapy utilizes a small, bladder-resident device that slowly releases erdafitinib, a potent FGFR tyrosine kinase inhibitor, directly into the bladder, achieving high local drug concentrations while minimizing systemic exposure. This localized delivery approach is intended to maximize anti-tumor activity within the bladder lining and enhance bladder preservation, making TAR‑210 a promising bladder-sparing option for patients who are unresponsive to BCG and ineligible or unwilling to undergo radical cystectomy. Currently, the drug is in Phase III stage of its development for the treatment of Non Muscle Invasive Bladder Cancer.

• TYRA-300: Tyra Biosciences, Inc

TYRA-300 is the Tyra Biosciences’ 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, including achondroplasia and hypochondroplasia. In oncology, TYRA-300 is being evaluated in metastatic urothelial cancer (mUC) and intermediate risk non-muscle invasive bladder cancer (IR NMIBC). Currently, the drug is in Phase II stage of its development for the treatment of Non Muscle Invasive Bladder Cancer.

• UGN-301: UroGen Pharma Ltd.

UGN-301 is an anti-CTLA-4 monoclonal antibody (zalifrelimab), originally licensed from Agenus Inc. in 2019. It is formulated with RTGel, our proprietary reverse-thermal hydrogel, for intravesical administration into the bladder. Intravesical administration of UGN-301 is designed to increase drug concentrations in the bladder without significant systemic exposure, potentially diminishing the systemic toxicity associated with CTLA-4 blockade. UroGen is evaluating UGN-301 in a multi-arm Phase I study of UGN-301 as monotherapy and in combination with other agents. The safety of UGN-301 is being evaluated in the monotherapy arm of the study as combination therapy for HG-NMIBC. Currently, the drug is in Phase I stage of its development for the treatment of Non Muscle Invasive Bladder Cancer.

NMIBC Market Drivers

• Increasing NMIBC Prevalence
• Advancements in Bladder Cancer Treatment

NMIBC Market Barriers

• Increasing use of Biologics and Targeted Therapies
• High Cost associated with the disease

The Non Muscle Invasive Bladder Cancer Pipeline report provides insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Non Muscle Invasive Bladder Cancer with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Non Muscle Invasive Bladder Cancer Treatment.
• Non Muscle Invasive Bladder Cancer Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Non Muscle Invasive Bladder Cancer Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Non Muscle Invasive Bladder Cancer market.

If you’re tracking ongoing NMIBC clinical trials, this press release is a must-read. Tap to see the breakthroughs @ NMIBC Treatment Drugs

Non Muscle Invasive Bladder Cancer Companies

CG Oncology, Janssen Research & Development, LLC, Tyra Biosciences, Inc, UroGen Pharma Ltd., Prokarium Ltd, Protara Therapeutics, ImmVira Pharma Co. Ltd, Trigone Pharma Ltd., Hoffmann-La Roche, Aura Biosciences, enGene Holdings Inc., Atonco Pharma and others.

Non Muscle Invasive Bladder Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Non Muscle Invasive Bladder Cancer Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

From emerging drug candidates to competitive intelligence, the NMIBC Pipeline Report covers it all – check it out now @ NMIBC Market Drivers and Barriers, and Future Perspectives

Scope of the NMIBC Pipeline Report

• Coverage- Global
• NMIBC Companies- CG Oncology, Janssen Research & Development, LLC, Tyra Biosciences, Inc, UroGen Pharma Ltd., Prokarium Ltd, Protara Therapeutics, ImmVira Pharma Co. Ltd, Trigone Pharma Ltd., Hoffmann-La Roche, Aura Biosciences, enGene Holdings Inc., Atonco Pharma and others.
• NMIBC Therapies- PF-06801591, Bacillus Calmette-Guerin, CG0070, Gemcitabine, APL-1202 treatment, Durvalumab, eRapa, Epirubicin Hydrochloride, Cabazitaxel, Gemcitabine, Cisplatin and others.
• NMIBC Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• NMIBC Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Stay ahead in oncology research – discover what’s next for the NMIBC treatment landscape in this detailed analysis @ NMIBC Emerging Drugs and Major Players

Table of Contents

1. Introduction

2. Executive Summary

3. Non Muscle Invasive Bladder Cancer: Overview

4. Pipeline Therapeutics

5. Therapeutic Assessment

6. Non Muscle Invasive Bladder Cancer– DelveInsight’s Analytical Perspective

7. Late Stage Products (Phase III)

8. Cretostimogene grenadenorepvec: CG Oncology

9. Mid Stage Products (Phase II)

10. TYRA-300: Tyra Biosciences, Inc

11. Early Stage Products (Phase I)

12. UGN-301: UroGen Pharma Ltd.

13. Preclinical and Discovery Stage Products

14. Drug Name: Company Name

15. Inactive Products

16. Non Muscle Invasive Bladder Cancer Key Companies

17. Non Muscle Invasive Bladder Cancer Key Products

18. Non Muscle Invasive Bladder Cancer- Unmet Needs

19. Non Muscle Invasive Bladder Cancer- Market Drivers and Barriers

20. Non Muscle Invasive Bladder Cancer- Future Perspectives and Conclusion

21. Non Muscle Invasive Bladder Cancer Analyst Views

22. Non Muscle Invasive Bladder Cancer Key Companies

23. Appendix

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