Bladder cancer Pipeline Assessment 2024: FDA Approvals, Clinical Trials, Therapies and Companies by DelveInsight | Aura Biosciences, BeiGene, Incyte, CG Oncology, FKD Therapies

Bladder cancer Pipeline Assessment 2024: FDA Approvals, Clinical Trials, Therapies and Companies by DelveInsight | Aura Biosciences, BeiGene, Incyte, CG Oncology, FKD Therapies

“Bladder cancer Pipeline”

(Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Bladder cancer pipeline constitutes 100+ key companies continuously working towards developing 100+ Bladder cancer treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

The Bladder cancer Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.


Bladder cancer Pipeline Insight, 2024 report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Bladder cancer Market.


Some of the key takeaways from the Bladder cancer Pipeline Report:

  • Companies across the globe are diligently working toward developing novel Bladder cancer treatment therapies with a considerable amount of success over the years. 
  • Bladder cancer companies working in the treatment market are Ractigen Therapeutics, XNK Therapeutics, Vaxiion Therapeutics, Vyriad, Inc., Istari Oncology Inc., Theralase Technologies Inc., Taiho Oncology, Inc., Lepu Biopharma CO.,Ltd., Janssen Research & Development, LLC, Asieris Pharmaceuticals, ImmunityBio, CG Oncology, UroGen, G1 Therapeutics, BeiGene, and others, are developing therapies for the Bladder cancer treatment 
  • Emerging Bladder cancer therapies in the different phases of clinical trials are- RAG-01, XNK03, VAX014, MV-NIS, Lerapolturev, TLD-1433, Futibatinib, HX-008, TAR-200, APL-1202, N-803, CG0070, UGN-102, Trilaciclib, Tislelizumab, and others are expected to have a significant impact on the Bladder cancer market in the coming years.   
  • In July 2022, The FDA has acknowledged receipt of a Biologics License Application (BLA) submitted by ImmunityBio, Inc. (NASDAQ: IBRX), for its antibody cytokine fusion protein proposed as a therapy for patients diagnosed with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) accompanied by Ta or T1 disease or without. ImmunityBio, a prominent clinical-stage immunotherapy company, filed the BLA citing promising outcomes from various studies on the investigational treatment, including the ongoing QUILT 3.032 trial. The Prescription Drug User Fee Act (PDUFA) target action date is slated for May 23, 2023.
  • In June 2022, CG Oncology disclosed preliminary findings from two ongoing clinical investigations to be showcased at The American Society of Clinical Oncology (ASCO) 2022 Annual Meeting. The initial presentation focuses on efficacy and safety outcomes from a global Phase 2 study (CORE1) assessing CG0070 combined with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for treating patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). The second presentation centers on a Phase 1b/2 study (CORE2) investigating CG0070 combined with OPDIVO® (nivolumab) as a neoadjuvant immunotherapy for Muscle-Invasive Bladder Cancer (MIBC) in cisplatin-ineligible patients.
  • In July 2022, Nanostics Inc. initiated a prospective clinical research endeavor aimed at confirming the efficacy of ClarityDX Bladder, a pioneering and less invasive diagnostic test for bladder cancer. This study leverages Nanostics’ ClarityDX diagnostic platform and is conducted in collaboration with the University of Alberta’s Alberta Prostate Cancer Research Initiative (APCaRI) and DynaLIFE Medical Labs.
  • In May 2022, Asieris Pharmaceuticals disclosed that the ANTICIPATE Study will be showcased at the 2022 American Society of Clinical Oncology (ASCO) annual meeting held from June 3-7, 2022, in Chicago. The study evaluates the administration of oral APL-1202 combined with BeiGene’s tislelizumab versus the sole use of tislelizumab as neoadjuvant therapy (NAC) in individuals diagnosed with muscle invasive bladder cancer (MIBC).
  • In March 2022, Protara Therapeutics, Inc. declared the dosing of the initial patient in ADVANCED-1, a Phase 1 clinical study assessing TARA-002, an investigational cell-based immunopotentiator developed for treating non-muscle invasive bladder cancer (NMIBC).
  • In January 2022, Vaxiion Therapeutics shared that the U.S. Food and Drug Administration (FDA) approved the company’s Investigational New Drug application (IND) for VAX014, allowing its investigative use for treating solid tumors resistant to conventional therapies through intralesional treatment. VAX014 represents a pioneering recombinant bacterial minicell-based oncolytic immunotherapy.


Bladder cancer Overview

The most prevalent tumor of the urinary tract is bladder cancer (BC). The bladder wall is composed of many layers. Different cell types make up each layer, and bladder cancer (BC) starts when normal bladder lining cells, most often urothelial cells, alter and proliferate uncontrollably to create masses known as tumors.


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Emerging Bladder cancer Drugs Under Different Phases of Clinical Development Include:

  • RAG-01: Ractigen Therapeutics
  • XNK03: XNK Therapeutics
  • VAX014: Vaxiion Therapeutics
  • MV-NIS: Vyriad, Inc.
  • Lerapolturev: Istari Oncology Inc.
  • TLD-1433: Theralase Technologies Inc.
  • Futibatinib: Taiho Oncology, Inc.
  • HX-008: Lepu Biopharma CO.,Ltd.
  • TAR-200: Janssen Research & Development, LLC
  • APL-1202: Asieris Pharmaceuticals
  • N-803: ImmunityBio
  • CG0070: CG Oncology
  • UGN-102: UroGen
  • Trilaciclib: G1 Therapeutics
  • Tislelizumab: BeiGene


Bladder cancer Route of Administration

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 

  • Inhalation
  • Inhalation/Intravenous/Oral
  • Intranasal
  • Intravenous
  • Intravenous/ Subcutaneous
  • NA
  • Oral
  • Oral/intranasal/subcutaneous
  • Parenteral
  • Subcutaneous


Bladder cancer Molecule Type

Bladder cancer Products have been categorized under various Molecule types, such as

  • Antibody
  • Antisense oligonucleotides
  • Immunotherapy
  • Monoclonal antibody
  • Peptides
  • Protein
  • Recombinant protein
  • Small molecule
  • Stem Cell
  • Vaccine


Bladder cancer Pipeline Therapeutics Assessment

  • Bladder cancer Assessment by Product Type
  • Bladder cancer By Stage and Product Type
  • Bladder cancer Assessment by Route of Administration
  • Bladder cancer By Stage and Route of Administration
  • Bladder cancer Assessment by Molecule Type
  • Bladder cancer by Stage and Molecule Type


DelveInsight’s Bladder cancer Report covers around 100+ products under different phases of clinical development like

  • Late-stage products (Phase III)
  • Mid-stage products (Phase II)
  • Early-stage product (Phase I)
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates
  • Route of Administration


Further Bladder cancer product details are provided in the report. Download the Bladder cancer pipeline report to learn more about the emerging Bladder cancer therapies


Some of the key companies in the Bladder cancer Therapeutics Market include:

Key companies developing therapies for Bladder cancer are – Janssen Research & Development, LLC, Astellas Pharma, RemeGen Co., Ltd., UroGen Pharma Ltd., Flame Biosciences, Aura Biosciences, BeiGene, Incyte Corporation, CG Oncology, FKD Therapies, Bristol-Myers Squibb, LintonPharm Co., Ltd., ImmunityBio, Inc., Hamlet Pharma AB, Asieris Pharmaceuticals, Pfizer, Taizhou Hanzhong biomedical co. LTD, Protara Therapeutics, CicloMed LLC, enGene, Inc., Emtora Biosciences, Theralase Inc.,  Vaxiion Therapeutics, QED Therapeutics, G1 Therapeutics, AN0025, Kyowa Kirin, Inc., Infinity Pharmaceuticals, Shanghai Hengrui Pharmaceutical Co., Ltd., HiberCell, Inc., Ikena Oncology, Genentech, Fusion Pharmaceuticals, GI Innovation,SOTIO Biotech AG, Celon Pharma SA, 4D Pharma PLC, and others.


Bladder cancer Pipeline Analysis:

The Bladder cancer pipeline report provides insights into 

  • The report provides detailed insights about companies that are developing therapies for the treatment of 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 Bladder cancer Treatment.
  • Bladder cancer key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • 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 Bladder cancer market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.


Download Sample PDF Report to know more about Bladder cancer drugs and therapies


Bladder cancer Pipeline Market Drivers

  • Increase in the number of patients suffering from non-muscle invasive bladder cancer, development of novel therapies and favorable government policies are some of the important factors that are fueling the Bladder cancer Market.


Bladder cancer Pipeline Market Barriers

  • However, identifying the patient population with specific mutations for targeted therapy regimens, lack of awareness about the advanced cancer therapies and other factors are creating obstacles in the Bladder cancer Market growth.


Scope of Bladder cancer Pipeline Drug Insight    

  • Coverage: Global
  • Key Bladder cancer Companies: Ractigen Therapeutics, XNK Therapeutics, Vaxiion Therapeutics, Vyriad, Inc., Istari Oncology Inc., Theralase Technologies Inc., Taiho Oncology, Inc., Lepu Biopharma CO.,Ltd., Janssen Research & Development, LLC, Asieris Pharmaceuticals, ImmunityBio, CG Oncology, UroGen, G1 Therapeutics, BeiGene, and others
  • Key Bladder cancer Therapies: RAG-01, XNK03, VAX014, MV-NIS, Lerapolturev, TLD-1433, Futibatinib, HX-008, TAR-200, APL-1202, N-803, CG0070, UGN-102, Trilaciclib, Tislelizumab, and others
  • Bladder cancer Therapeutic Assessment: Bladder cancer current marketed and Bladder cancer emerging therapies
  • Bladder cancer Market Dynamics: Bladder cancer market drivers and Bladder cancer market barriers 


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Table of Contents

1. Bladder cancer Report Introduction

2. Bladder cancer Executive Summary

3. Bladder cancer Overview

4. Bladder cancer- Analytical Perspective In-depth Commercial Assessment

5. Bladder cancer Pipeline Therapeutics

6. Bladder cancer Late Stage Products (Phase II/III)

7. Bladder cancer Mid Stage Products (Phase II)

8. Bladder cancer Early Stage Products (Phase I)

9. Bladder cancer Preclinical Stage Products

10. Bladder cancer Therapeutics Assessment

11. Bladder cancer Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Bladder cancer Key Companies

14. Bladder cancer Key Products

15. Bladder cancer Unmet Needs

16 . Bladder cancer Market Drivers and Barriers

17. Bladder cancer Future Perspectives and Conclusion

18. Bladder cancer Analyst Views

19. Appendix

20. About DelveInsight


About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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