Uveal Melanoma Pipeline 2025: FDA Updates, Therapy Innovations, And Clinical Trial Landscape Analysis By Delveinsight Novartis, Foghorn Therapeutics Inc., Trisalus Life Sciences, Inc., Astrazeneca

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(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Uveal Melanoma pipeline constitutes 25+ key companies continuously working towards developing 30+ Uveal Melanoma treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

“Uveal Melanoma Pipeline Insight, 2025 " report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Uveal Melanoma Market.

The Uveal Melanoma 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.

Some of the key takeaways from the Uveal Melanoma Pipeline Report:

• Companies across the globe are diligently working toward developing novel Uveal Melanoma treatment therapies with a considerable amount of success over the years.

• Uveal Melanoma companies working in the treatment market areAura Biosciences, IDEAYA Biosciences, Replimune, Linnaeus Therapeutics, Novartis, TriSalus Life Sciences, Delcath Systems, Immunocore, and others , are developing therapies for the Uveal Melanoma treatment

• Emerging Uveal Melanoma therapies in the different phases of clinical trials are- Belzupacap sarotalocan, Darovasertib, RP2, LNS8801, DYP688, Nelitolimod, HEPZATO KIT (melphalan), KIMMTRAK (tebentafusp-tebn), and others are expected to have a significant impact on the Uveal Melanoma market in the coming years.

• In April 2025, IDEAYA Biosciences announced a successful FDA Type D meeting on the Phase III registrational trial design that will assess the safety and efficacy of darovasertib for potential regulatory approval as neoadjuvant therapy for primary uveal melanoma. IDEAYA is targeting to initiate the Phase III randomized clinical trial evaluating neoadjuvant darovasertib in primary uveal melanoma in the first half of 2025.

• In March 2025, IDEAYA Biosciences announced that the FDA has granted darovasertib, a potential first-in-class PKC inhibitor, BTD for the potential treatment of adult patients with primary uveal melanoma for whom enucleation has been recommended.

• In February 2025, the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology to recommend HEPZATO KIT as a Category 2A treatment option for patients with hepatic-dominant metastatic uveal melanoma.

• In December 2024, IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision oncology company advancing targeted therapies, announced that the Independent Data Monitoring Committee (IDMC) has endorsed a recommended dose and confirmed the completion of Part 2a dose optimization. This decision is consistent with the U.S. FDA's Project Optimus framework and paves the way for a potential registration-enabling Phase 2/3 trial evaluating the combination of darovasertib and crizotinib in first-line (1L) treatment for HLA-A2-negative (HLA-A2(-)) metastatic uveal melanoma (MUM).

Uveal Melanoma Overview

Uveal melanoma is a type of cancer that occurs in the uvea, which is the middle layer of the eye. The uvea consists of the iris (colored part of the eye), the ciliary body (a ring of tissue behind the iris), and the choroid (a layer of blood vessels that nourishes the retina).

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Emerging Uveal Melanoma Drugs Under Different Phases of Clinical Development Include:

• Belzupacap sarotalocan: Aura Biosciences

• Darovasertib: IDEAYA Biosciences

• RP2: Replimune

• LNS8801: Linnaeus Therapeutics

• DYP688: Novartis

• Nelitolimod: TriSalus Life Sciences

• HEPZATO KIT (melphalan): Delcath Systems

• KIMMTRAK (tebentafusp-tebn): Immunocore

Uveal Melanoma Route of Administration

Uveal Melanoma 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

• Subcutaneous

• Intravenous

• Intramuscular

Uveal Melanoma Molecule Type

Uveal Melanoma Products have been categorized under various Molecule types, such as

• Bispecific Antibody

• Peptides

• Small molecule

• Gene therapy

Uveal Melanoma Pipeline Therapeutics Assessment

• Uveal Melanoma Assessment by Product Type

• Uveal Melanoma By Stage and Product Type

• Uveal Melanoma Assessment by Route of Administration

• Uveal Melanoma By Stage and Route of Administration

• Uveal Melanoma Assessment by Molecule Type

• Uveal Melanoma by Stage and Molecule Type

DelveInsight's Uveal Melanoma Report covers around 30+ 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 Uveal Melanoma product details are provided in the report. Download the Uveal Melanoma pipeline report to learn more about the emerging Uveal Melanoma therapies

Some of the key companies in the Uveal Melanoma Therapeutics Market include:

Key companies developing therapies for Uveal Melanoma are - Novartis, Foghorn Therapeutics Inc., TriSalus Life Sciences, Inc., AstraZeneca, IDEAYA Biosciences, Verastem, Inc., Pfizer, Acrotech Biopharma Inc., Bristol-Myers Squibb, Iovance Biotherapeutics, Inc., Modulation Therapeutics, Inc., BioMed Valley Discoveries, Inc, Bellicum Pharmaceuticals, Merck Sharp & Dohme LLC, Eisai Inc., Delcath Systems Inc., Vanquish Oncology, Inc., and others.

Uveal Melanoma Pipeline Analysis:

The Uveal Melanoma pipeline report provides insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Uveal Melanoma 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 Uveal Melanoma Treatment.

• Uveal Melanoma key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

• Uveal Melanoma 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 Uveal Melanoma 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 Uveal Melanoma drugs and therapies

Uveal Melanoma Pipeline Market Drivers

• Increasing Prevalence of the eye cancer, increase in research and developmental activities are some of the important factors that are fueling the Uveal Melanoma Market.

Uveal Melanoma Pipeline Market Barriers

• However, high-cost associated with the disease, lack of awareness about the disease and other factors are creating obstacles in the Uveal Melanoma Market growth.

Scope of Uveal Melanoma Pipeline Drug Insight

• Coverage: Global

• Key Uveal Melanoma Companies: Aura Biosciences, IDEAYA Biosciences, Replimune, Linnaeus Therapeutics, Novartis, TriSalus Life Sciences, Delcath Systems, Immunocore, and others

• Key Uveal Melanoma Therapies: Belzupacap sarotalocan, Darovasertib, RP2, LNS8801, DYP688, Nelitolimod, HEPZATO KIT (melphalan), KIMMTRAK (tebentafusp-tebn), and others

• Uveal Melanoma Therapeutic Assessment: Uveal Melanoma current marketed and Uveal Melanoma emerging therapies

• Uveal Melanoma Market Dynamics: Uveal Melanoma market drivers and Uveal Melanoma market barriers

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Table of Contents

1. Uveal Melanoma Report Introduction

2. Uveal Melanoma Executive Summary

3. Uveal Melanoma Overview

4. Uveal Melanoma- Analytical Perspective In-depth Commercial Assessment

5. Uveal Melanoma Pipeline Therapeutics

6. Uveal Melanoma Late Stage Products (Phase II/III)

7. Uveal Melanoma Mid Stage Products (Phase II)

8. Uveal Melanoma Early Stage Products (Phase I)

9. Uveal Melanoma Preclinical Stage Products

10. Uveal Melanoma Therapeutics Assessment

11. Uveal Melanoma Inactive Products

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

13. Uveal Melanoma Key Companies

14. Uveal Melanoma Key Products

15. Uveal Melanoma Unmet Needs

16 . Uveal Melanoma Market Drivers and Barriers

17. Uveal Melanoma Future Perspectives and Conclusion

18. Uveal Melanoma 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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