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

The Primary Hyperoxaluria 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 Primary Hyperoxaluria Pipeline Report:

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

• Primary Hyperoxaluria companies working in the treatment market are Chinook Therapeutics, Cantero Therapeutics, BioMarin Pharmaceutical, Inc, OxThera, Dicerna Pharmaceuticals, Inc., and others, are developing therapies for the Primary Hyperoxaluria treatment

• Emerging Primary Hyperoxaluria therapies in the different phases of clinical trials are- CHK-336, BBP-711, BMN 255, Oxabact, Nedosiran, and others are expected to have a significant impact on the Primary Hyperoxaluria market in the coming years.

• In July 2025, Arbor Biotechnologies announced that the first patient has been treated in the Phase 1/2 redePHine trial (NCT06839235), evaluating ABO-101, an investigational gene-editing therapy for primary hyperoxaluria type 1 (PH1). The initial dosing took place at the Mayo Clinic. Within the 28-day dose-limiting toxicity observation period, no serious adverse events (AEs) were reported, and the study’s safety board has recommended moving forward with additional dosing in the trial.

• In May 2025, Arbor Biotechnologies, Inc., a biotech firm focused on advancing next-generation genetic therapies, has presented IND- and CTA-supporting data for its lead candidate, ABO-101, targeting primary hyperoxaluria type 1 (PH1), at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) in New Orleans, Louisiana.

• In February 2025, The U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) to Arbor Biotechnologies’ gene-editing therapy, ABO-101, for the treatment of primary hyperoxaluria type 1 (PH1). These designations provide Arbor with various incentives, including tax credits, waivers of certain regulatory fees, potential market exclusivity, and eligibility for a pediatric priority review voucher if the therapy gains FDA approval.

Primary Hyperoxaluria Overview

Primary Hyperoxaluria is a rare genetic disorder characterized by the overproduction of oxalate, a substance that is normally eliminated through the kidneys in the urine. In individuals with Primary Hyperoxaluria, there is a defect in the liver enzymes responsible for breaking down glyoxylate, leading to an accumulation of oxalate in the body.

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Emerging Primary Hyperoxaluria Drugs Under Different Phases of Clinical Development Include:

• CHK-336: Chinook Therapeutics

• BBP-711: Cantero Therapeutics

• BMN 255: BioMarin Pharmaceutical, Inc

• Oxabact: OxThera

• Nedosiran: Dicerna Pharmaceuticals, Inc.

Primary Hyperoxaluria Route of Administration

Primary Hyperoxaluria 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

• Parenteral

• Intravenous

• Subcutaneous

• Topical

• Molecule Type

Primary Hyperoxaluria Molecule Type

Primary Hyperoxaluria Products have been categorized under various Molecule types, such as

• Monoclonal Antibody

• Peptides

• Polymer

• Small molecule

• Gene therapy

• Product Type

Primary Hyperoxaluria Pipeline Therapeutics Assessment

• Primary Hyperoxaluria Assessment by Product Type

• Primary Hyperoxaluria By Stage and Product Type

• Primary Hyperoxaluria Assessment by Route of Administration

• Primary Hyperoxaluria By Stage and Route of Administration

• Primary Hyperoxaluria Assessment by Molecule Type

• Primary Hyperoxaluria by Stage and Molecule Type

DelveInsight’s Primary Hyperoxaluria Report covers around 6+ 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 Primary Hyperoxaluria product details are provided in the report. Download the Primary Hyperoxaluria pipeline report to learn more about the emerging Primary Hyperoxaluria therapies

Some of the key companies in the Primary Hyperoxaluria Therapeutics Market include:

Key companies developing therapies for Primary Hyperoxaluria are – Alnylam Pharmaceuticals, Inc., Genentech, Inc., Dicerna Pharmaceuticals, Inc., Pfizer Inc., Zhejiang Tianxin Pharmaceutical Co., Wuxi Further Pharmaceutical Co Ltd, Tecoland Corporation, Takeda Pharmaceuticals Company Limited, Intellia Therapeutics, Inc., and others.

Primary Hyperoxaluria Pipeline Analysis:

The Primary Hyperoxaluria pipeline report provides insights into

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

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

• Primary Hyperoxaluria 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 Primary Hyperoxaluria 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 Primary Hyperoxaluria drugs and therapies

Primary Hyperoxaluria Pipeline Market Drivers

• Rising Prevalence of Primary hyperoxaluria, increasing demand of disease specific novel treatment are some of the important factors that are fueling the Primary Hyperoxaluria Market.

Primary Hyperoxaluria Pipeline Market Barriers

• However, high cost of treatment and diagnosis for Hyperoxaluria, limited research and development for treatment and other factors are creating obstacles in the Primary Hyperoxaluria Market growth.

Scope of Primary Hyperoxaluria Pipeline Drug Insight

• Coverage: Global

• Key Primary Hyperoxaluria Companies: Chinook Therapeutics, Cantero Therapeutics, BioMarin Pharmaceutical, Inc, OxThera, Dicerna Pharmaceuticals, Inc., and others

• Key Primary Hyperoxaluria Therapies: CHK-336, BBP-711, BMN 255, Oxabact, Nedosiran, and others

• Primary Hyperoxaluria Therapeutic Assessment: Primary Hyperoxaluria current marketed and Primary Hyperoxaluria emerging therapies

• Primary Hyperoxaluria Market Dynamics: Primary Hyperoxaluria market drivers and Primary Hyperoxaluria market barriers

Request for Sample PDF Report for Primary Hyperoxaluria Pipeline Assessment and clinical trials

Table of Contents

1. Primary Hyperoxaluria Report Introduction

2. Primary Hyperoxaluria Executive Summary

3. Primary Hyperoxaluria Overview

4. Primary Hyperoxaluria- Analytical Perspective In-depth Commercial Assessment

5. Primary Hyperoxaluria Pipeline Therapeutics

6. Primary Hyperoxaluria Late Stage Products (Phase II/III)

7. Primary Hyperoxaluria Mid Stage Products (Phase II)

8. Primary Hyperoxaluria Early Stage Products (Phase I)

9. Primary Hyperoxaluria Preclinical Stage Products

10. Primary Hyperoxaluria Therapeutics Assessment

11. Primary Hyperoxaluria Inactive Products

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

13. Primary Hyperoxaluria Key Companies

14. Primary Hyperoxaluria Key Products

15. Primary Hyperoxaluria Unmet Needs

16 . Primary Hyperoxaluria Market Drivers and Barriers

17. Primary Hyperoxaluria Future Perspectives and Conclusion

18. Primary Hyperoxaluria 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.

Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Gaurav Bora
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: NV
Country: United States
Website: https://www.delveinsight.com/

Press Release Distributed by ABNewswire.com

To view the original version on ABNewswire visit: Primary Hyperoxaluria Pipeline 2025: Therapies, MOA Insights, and Key Clinical Trial Updates by DelveInsight | Alnylam Pharma, Genentech, Dicerna Pharma, Pfizer Inc., Zhejiang Tianxin Pharma, Wuxi

DelveInsight’s “Pulmonary Arterial Hypertension Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the Pulmonary Arterial Hypertension, historical and forecasted epidemiology as well as the Pulmonary Arterial Hypertension market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

The Pulmonary Arterial Hypertension market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Pulmonary Arterial Hypertension pipeline products will significantly revolutionize the Pulmonary Arterial Hypertension market dynamics.

To Know in detail about the Pulmonary Arterial Hypertension market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Pulmonary Arterial Hypertension Market Forecast

Some of the key facts of the Pulmonary Arterial Hypertension Market Report:

• The Pulmonary Arterial Hypertension market size was valued ~USD 4,949 million in 2022 and is anticipated to grow with a significant CAGR during the study period (2020-2034).

• In August 2025, VASTHERA Co., Ltd. announced FDA clearance of its Investigational New Drug (IND) application to begin a Phase 1 trial for VTB-10, a novel candidate for pulmonary arterial hypertension (PAH). Developed via the company’s proprietary Redoxizyme™ platform, VTB-10 is a first-in-class small molecule enzyme (Chemzyme) designed to mimic the function of peroxiredoxin (PRX), which is deficient in PAH lesions. Preclinical data showed that VTB-10 not only reversed abnormal vascular remodeling but also restored healthy endothelial function, offering a dual mechanism of action that sets it apart from current treatment options.

• In March 2025, Merck (NYSE: MRK), also known as MSD outside the U.S. and Canada, has shared initial results from its Phase 3 ZENITH trial evaluating WINREVAIR™ (sotatercept-csrk) versus placebo in adults with pulmonary arterial hypertension (PAH, Group 1 PH), classified as WHO functional class III or IV and at high risk of mortality, despite receiving the maximum tolerated background PAH therapy. With a median follow-up of 10.6 months (range: 0.3–26.1), WINREVAIR significantly reduced the relative risk of major morbidity and mortality events—including all-cause death, lung transplantation, or PAH-related hospitalization (≥24 hours)—by 76% (HR=0.24 [95% CI, 0.13–0.43]; p

• In January 2025, Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced preliminary findings from its Phase 3 ZENITH trial assessing WINREVAIR™ (sotatercept-csrk) against placebo in adults with pulmonary arterial hypertension (PAH, Group 1 PH), specifically those categorized as WHO functional class III or IV and considered at high risk of mortality despite being on optimized background PAH treatment. Over a median follow-up period of 10.6 months (range: 0.3–26.1), WINREVAIR demonstrated a 76% reduction in the relative risk of major morbidity and mortality events—defined as all-cause death, lung transplant, or PAH-related hospitalization lasting 24 hours or more—compared to placebo (HR=0.24 [95% CI, 0.13–0.43]; p

• In October 2024, Inhibikase Therapeutics, Inc. (Nasdaq: IKT), a clinical-stage pharmaceutical company focused on developing protein kinase inhibitors to address cardiopulmonary and neurodegenerative diseases via Abelson Tyrosine Kinase inhibition, has announced the closing of a $110 million private placement. This funding, generated through the sale of common stock and accompanying warrants, could potentially reach $275 million upon full cash exercise of the warrants, prior to deducting placement agent fees and expenses. The proceeds will support the execution of the Phase 2b ‘702’ trial for pulmonary arterial hypertension (PAH) and general corporate activities.

• In July 2024, Aerovate Therapeutics is reducing its workforce by 78%, following the Phase IIb trial failure of its pulmonary arterial hypertension (PAH) drug, AV-101. The Massachusetts-based biotech disclosed the layoffs in an SEC filing, estimating related costs at approximately $5.6 million.

• In March 2024, Merck (NYSE: MRK), also known as MSD outside the United States and Canada, has announced today that the U.S. Food and Drug Administration (FDA) has given approval for sotatercept-csrk (U.S. Brand Name: WINREVAIR™, for injection, 45mg, 60mg) for the management of pulmonary arterial hypertension (PAH) in adults. This medication is indicated to enhance exercise capacity, ameliorate World Health Organization (WHO) functional class (FC), and mitigate the risk of clinical worsening events. WINREVAIR had previously received Breakthrough Therapy Designation from the FDA. It represents the first FDA-approved therapy targeting activin signaling inhibition for PAH, offering a novel therapeutic approach by modulating the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation associated with PAH.

• In January 2024, Pulnovo Medical Limited, a globally renowned innovator in medical devices for treating Pulmonary Hypertension (PH) and Heart Failure (HF), has recently achieved Humanitarian Use Device (HUD) designation from the US FDA and approval from China’s National Medical Products Administration (NMPA) for the PADN Catheter and Generator. The PADN technology marks a significant breakthrough in the realm of global interventional pulmonary arterial hypertension (PAH), addressing challenges in PAH interventional therapy

• In 2022, the Pulmonary Arterial Hypertension treatment market in the US was valued at around USD 3,898.5 million, and it is expected to grow due to rising awareness of the condition and the introduction of new therapies.

• In 2022, the Pulmonary Arterial Hypertension market size in EU4 and the UK was estimated at approximately USD 816.4 million, accounting for nearly 16% of the total market revenue across the 7MM.

• As per DelveInsight’s estimates, Germany had the largest Pulmonary Arterial Hypertension drugs market in EU4 and the UK, reaching around USD 210.3 million in 2022, followed by France at approximately USD 207.9 million. In contrast, Spain had the smallest market in 2023.

• The evolving pipeline for pulmonary arterial hypertension (PAH) includes various treatments such as Sotatercept (MK-7962) from Merck, ralinepag by United Therapeutics, RT234 (vardenafil inhalation powder) developed by Respira Therapeutics, seralutinib (GB002) from Gossamer Bio, YUTREPIA (an inhaled dry powder formulation of treprostinil) created by Liquidia Technologies, and TNX-201 by Tenax Therapeutics. These treatments are anticipated to be introduced and made available throughout the forecast period from 2023 to 2032.

• In 2022, the collective number of existing cases of pulmonary arterial hypertension (PAH) in the 7MM (Seven Major Markets) was estimated to be around 88,100 cases. Over the study duration (2019─2032), it is anticipated that these cases will show a gradual increase, projected to grow at a Compound Annual Growth Rate (CAGR) of 0.4% by 2032

• In the European Union Four (EU4) and the United Kingdom (UK) combined, there were an estimated 19,720 diagnosed cases of pulmonary arterial hypertension (PAH) in 2022. It is anticipated that these diagnosed cases will experience an increase throughout the study period from 2019 to 2032.

• In 2022, Japan recorded an estimated 204 cases of class I, 1,143 occurrences of class II, 901 cases of class III, and 136 cases of class IV pulmonary arterial hypertension (PAH). It is anticipated that these figures will show a decline over the study period from 2019 to 2032.

• Key Pulmonary Arterial Hypertension Companies: Aerovate Therapeutics, Novartis, Keros Therapeutics, Vigonvita Life Sciences, Insmed Incorporated, Chugai Pharmaceutical, Merck Sharp & Dohme, Janssen Pharmaceutical, Actelion, Gossamer Bio, Lung Biotechnology PBC, United Therapeutics, Gilead Science, Acceleron Pharma, Eiger BioPharmaceuticals, AstraZeneca, and others

• Key Pulmonary Arterial Hypertension Therapies: AV-101, LTP001, KER-012, TPN171H, Treprostinil Palmitil, Satralizumab (Genetical Recombination), Sotatercept, Macitentan, ACT-293987, GB002 (seralutinib), Parenteral Treprostinil, Ralinepag, Selonsertib, Sotatercept, ubenimex, Olaparib, and others

• The Pulmonary Arterial Hypertension epidemiology based on gender analyzed that females are more affected with Pulmonary Arterial Hypertension than males

• The Pulmonary Arterial Hypertension market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Pulmonary Arterial Hypertension pipeline products will significantly revolutionize the Pulmonary Arterial Hypertension market dynamics.

Pulmonary Arterial Hypertension Overview

When measured by right heart catheterization, pulmonary hypertension (PH) is defined as mean pulmonary artery pressure greater than 25 mm Hg at rest or greater than 30 mm Hg during activity. PH has been classified into five groups by the World Health Organization (WHO) on the basis of shared pathophysiology, clinical presentation, and available treatments.

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Pulmonary Arterial Hypertension Epidemiology

The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Pulmonary Arterial Hypertension Epidemiology Segmentation:

The Pulmonary Arterial Hypertension market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Total Prevalence of Pulmonary Arterial Hypertension

• Prevalent Cases of Pulmonary Arterial Hypertension by severity

• Gender-specific Prevalence of Pulmonary Arterial Hypertension

• Diagnosed Cases of Episodic and Chronic Pulmonary Arterial Hypertension

Download the report to understand which factors are driving Pulmonary Arterial Hypertension epidemiology trends @ Pulmonary Arterial Hypertension Epidemiology Forecast

Pulmonary Arterial Hypertension Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Pulmonary Arterial Hypertension market or expected to get launched during the study period. The analysis covers Pulmonary Arterial Hypertension market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the Pulmonary Arterial Hypertension Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Pulmonary Arterial Hypertension Therapies and Key Companies

• AV-101: Aerovate Therapeutics

• LTP001: Novartis

• KER-012: Keros Therapeutics

• TPN171H: Vigonvita Life Sciences

• Treprostinil Palmitil: Insmed Incorporated

• Satralizumab (Genetical Recombination): Chugai Pharmaceutical

• Sotatercept: Merck Sharp & Dohme

• Macitentan: Janssen Pharmaceutical

• ACT-293987: Actelion

• GB002 (seralutinib): Gossamer Bio

• Parenteral Treprostinil: Lung Biotechnology PBC

• Ralinepag: United Therapeutics

• Selonsertib: Gilead Sciences

• Sotatercept: Acceleron Pharma

• ubenimex: Eiger BioPharmaceuticals

• Olaparib: AstraZeneca

Discover more about therapies set to grab major Pulmonary Arterial Hypertension market share @ Pulmonary Arterial Hypertension Treatment Landscape

Pulmonary Arterial Hypertension Market Strengths

• Better understanding of disease pathophysiology and genetics has improved diagnosis and treatment, reducing mortality

• There have been significant developments in the treatment regime leading to the approval of novel therapies and more defined treatment guidelines

Pulmonary Arterial Hypertension Market Opportunities

• Further research on diagnostic and prognostic blood biomarkers in asymptomatic or specific at-risk populations to improve diagnosis and develop novel treatment options

• The increasing prevalence of PAH, along with government support for the development of orphan drugs, provide companies with an excellent opportunity to invest in the PAH market

Scope of the Pulmonary Arterial Hypertension Market Report

• Study Period: 2020–2034

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key Pulmonary Arterial Hypertension Companies: Aerovate Therapeutics, Novartis, Keros Therapeutics, Vigonvita Life Sciences, Insmed Incorporated, Chugai Pharmaceutical, Merck Sharp & Dohme, Janssen Pharmaceutical, Actelion, Gossamer Bio, Lung Biotechnology PBC, United Therapeutics, Gilead Science, Acceleron Pharma, Eiger BioPharmaceuticals, AstraZeneca, and others

• Key Pulmonary Arterial Hypertension Therapies: AV-101, LTP001, KER-012, TPN171H, Treprostinil Palmitil, Satralizumab (Genetical Recombination), Sotatercept, Macitentan, ACT-293987, GB002 (seralutinib), Parenteral Treprostinil, Ralinepag, Selonsertib, Sotatercept, ubenimex, Olaparib, and others

• Pulmonary Arterial Hypertension Therapeutic Assessment: Pulmonary Arterial Hypertension current marketed and Pulmonary Arterial Hypertension emerging therapies

• Pulmonary Arterial Hypertension Market Dynamics: Pulmonary Arterial Hypertension market drivers and Pulmonary Arterial Hypertension market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• Pulmonary Arterial Hypertension Unmet Needs, KOL’s views, Analyst’s views, Pulmonary Arterial Hypertension Market Access and Reimbursement

To know more about Pulmonary Arterial Hypertension companies working in the treatment market, visit @ Pulmonary Arterial Hypertension Clinical Trials and Therapeutic Assessment

Table of Contents

1. Pulmonary Arterial Hypertension Market Report Introduction

2. Executive Summary for Pulmonary Arterial Hypertension

3. SWOT analysis of Pulmonary Arterial Hypertension

4. Pulmonary Arterial Hypertension Patient Share (%) Overview at a Glance

5. Pulmonary Arterial Hypertension Market Overview at a Glance

6. Pulmonary Arterial Hypertension Disease Background and Overview

7. Pulmonary Arterial Hypertension Epidemiology and Patient Population

8. Country-Specific Patient Population of Pulmonary Arterial Hypertension

9. Pulmonary Arterial Hypertension Current Treatment and Medical Practices

10. Pulmonary Arterial Hypertension Unmet Needs

11. Pulmonary Arterial Hypertension Emerging Therapies

12. Pulmonary Arterial Hypertension Market Outlook

13. Country-Wise Pulmonary Arterial Hypertension Market Analysis (2020–2034)

14. Pulmonary Arterial Hypertension Market Access and Reimbursement of Therapies

15. Pulmonary Arterial Hypertension Market Drivers

16. Pulmonary Arterial Hypertension Market Barriers

17. Pulmonary Arterial Hypertension Appendix

18. Pulmonary Arterial Hypertension Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare 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 the business growth and overcome challenges with a practical approach

Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Gaurav Bora
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: NV
Country: United States
Website: https://www.delveinsight.com/

Press Release Distributed by ABNewswire.com

To view the original version on ABNewswire visit: Pulmonary Arterial Hypertension Market Expected to Gain Momentum Through 2034, According to DelveInsight | Merck, Janssen Pharma, Aerovate Therapeutics, Novartis, Insmed Inc, Chugai Pharma, Keros

“Anti-CD152 Antibody Pipeline Insight, 2025“ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Anti-CD152 Antibody Market.

The Anti-CD152 Antibody 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 Anti-CD152 Antibody Pipeline Report:

• Companies across the globe are diligently working toward developing novel Anti-CD152 Antibody treatment therapies with a considerable amount of success over the years.

• Anti-CD152 Antibody companies working in the treatment market are RemeGen, Caribou Biosciences, Precision Biosciences, TG Therapeutics, Xencor, Horizon Therapeutics, Morphosys, and others, are developing therapies for the Anti-CD152 Antibody treatment

• Emerging Anti-CD152 Antibody therapies in the different phases of clinical trials are- RC58, CB-010, PBCAR19B, TG-1801, Obexelimab (XmAb5871), Inebilizumab, Tafasitamab, and others are expected to have a significant impact on the Anti-CD152 Antibody market in the coming years.

• In May 2024, ADC Therapeutics released topline Phase II data for its Anti-CD152 Antibody drug conjugate Zynlonta (loncastuximab tesirine-lpyl), showing high treatment response rates in patients with relapsed or refractory marginal zone lymphoma. The early data, from 15 evaluable patients out of 50 enrolled in the single-arm, open-label mid-stage study, revealed that 13 patients achieved complete response (CR) and one patient demonstrated partial response. All responses were maintained until the data cut-off.

Anti-CD152 Antibody Overview

Anti-CD152 antibody is a type of immunotherapy that targets CD152, also known as CTLA-4 (Cytotoxic T-Lymphocyte Antigen-4)—a protein receptor found on T cells. CTLA-4 acts as an immune checkpoint that downregulates immune responses. By blocking CTLA-4, anti-CD152 antibodies help enhance T cell activation and boost the immune system’s ability to attack cancer cells or fight infections. These antibodies are being explored in cancer immunotherapy and autoimmune disease treatment, aiming to modulate immune function either by enhancing it (in cancer) or suppressing it (in autoimmune disorders), depending on the therapeutic context.

Get a Free Sample PDF Report to know more about Anti-CD152 Antibody Pipeline Therapeutic Assessment-

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Emerging Anti-CD152 Antibody Drugs Under Different Phases of Clinical Development Include:

• RC58: RemeGen

• CB-010: Caribou Biosciences

• PBCAR19B: Precision Biosciences

• TG-1801: TG Therapeutics

• Obexelimab (XmAb5871): Xencor

• Inebilizumab: Horizon Therapeutics

• Tafasitamab: Morphosys

Anti-CD152 Antibody Pipeline Therapeutics Assessment

• Anti-CD152 Antibody Assessment by Product Type

• Anti-CD152 Antibody By Stage and Product Type

• Anti-CD152 Antibody Assessment by Route of Administration

• Anti-CD152 Antibody By Stage and Route of Administration

• Anti-CD152 Antibody Assessment by Molecule Type

• Anti-CD152 Antibody by Stage and Molecule Type

DelveInsight’s Anti-CD152 Antibody Report covers around 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 Anti-CD152 Antibody product details are provided in the report. Download the Anti-CD152 Antibody pipeline report to learn more about the emerging Anti-CD152 Antibody therapies

Some of the key companies in the Anti-CD152 Antibody Therapeutics Market include:

Key companies developing therapies for Anti-CD152 Antibody are – TG Therapeutics, Merck kGaA, Generium Pharmaceutical, Sanofi, Incyte Corporation, Amgen, Viela Bio, and others.

Anti-CD152 Antibody Pipeline Analysis:

The Anti-CD152 Antibody pipeline report provides insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Anti-CD152 Antibody 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 Anti-CD152 Antibody Treatment.

• Anti-CD152 Antibody key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

• Anti-CD152 Antibody 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 Anti-CD152 Antibody 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 Anti-CD152 Antibody drugs and therapies

Anti-CD152 Antibody Pipeline Market Drivers

• High incidence rates of B-cell malignancies, rise in healthcare investment (by the government and private organizations) are some of the important factors that are fueling the Anti-CD152 Antibody Market.

Anti-CD152 Antibody Pipeline Market Barriers

• However, side effects associated with the Treatment, high cost associated with the Treatment and other factors are creating obstacles in the Anti-CD152 Antibody Market growth.

Scope of Anti-CD152 Antibody Pipeline Drug Insight

• Coverage: Global

• Key Anti-CD152 Antibody Companies: RemeGen, Caribou Biosciences, Precision Biosciences, TG Therapeutics, Xencor, Horizon Therapeutics, Morphosys, and others

• Key Anti-CD152 Antibody Therapies: RC58, CB-010, PBCAR19B, TG-1801, Obexelimab (XmAb5871), Inebilizumab, Tafasitamab, and others

• Anti-CD152 Antibody Therapeutic Assessment: Anti-CD152 Antibody current marketed and Anti-CD152 Antibody emerging therapies

• Anti-CD152 Antibody Market Dynamics: Anti-CD152 Antibody market drivers and Anti-CD152 Antibody market barriers

Request for Sample PDF Report for Anti-CD152 Antibody Pipeline Assessment and clinical trials

Table of Contents

1. Anti-CD152 Antibody Report Introduction

2. Anti-CD152 Antibody Executive Summary

3. Anti-CD152 Antibody Overview

4. Anti-CD152 Antibody- Analytical Perspective In-depth Commercial Assessment

5. Anti-CD152 Antibody Pipeline Therapeutics

6. Anti-CD152 Antibody Late Stage Products (Phase II/III)

7. Anti-CD152 Antibody Mid Stage Products (Phase II)

8. Anti-CD152 Antibody Early Stage Products (Phase I)

9. Anti-CD152 Antibody Preclinical Stage Products

10. Anti-CD152 Antibody Therapeutics Assessment

11. Anti-CD152 Antibody Inactive Products

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

13. Anti-CD152 Antibody Key Companies

14. Anti-CD152 Antibody Key Products

15. Anti-CD152 Antibody Unmet Needs

16 . Anti-CD152 Antibody Market Drivers and Barriers

17. Anti-CD152 Antibody Future Perspectives and Conclusion

18. Anti-CD152 Antibody 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.

Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Gaurav Bora
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: NV
Country: United States
Website: https://www.delveinsight.com/

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To view the original version on ABNewswire visit: Anti-CD152 Antibody Pipeline 2025: MOA, ROA, FDA-Approved Drugs, and Clinical Trial Progress Assessment by DelveInsight | Precision Biosciences, TG Therapeutics, RemeGen, Caribou Biosciences, Xencor

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

The AL Amyloidosis 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 AL Amyloidosis Pipeline Report:

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

• AL Amyloidosis companies working in the treatment market are HaemaLogiX, Zentalis Pharmaceuticals, Sorrento Therapeutics, Sanofi, Astellas Pharma GmbH, GlaxoSmithKline, Takeda Oncology, Caelum Biosciences, and others, are developing therapies for the AL Amyloidosis treatment

• Emerging AL Amyloidosis therapies in the different phases of clinical trials are- LambdaMab, ZN d5, STI-6129, Isatuximab, Bendamustine, Belantamab mafodotin, Ixazomib, CAEL-101, and others are expected to have a significant impact on the AL Amyloidosis market in the coming years.

• In July 2025, AstraZeneca’s anselamimab did not demonstrate clinical benefit in patients with light chain (AL) amyloidosis in two Phase III trials. The antibody, designed to deplete light chains, was being evaluated under the Cardiac Amyloid Reaching for Extended Survival (CARES) program in patients with Mayo stage IIIa (NCT04512235) and stage IIIb (NCT04504825) AL amyloidosis. In both studies, the drug failed to reach statistical significance for the primary endpoint, which assessed a composite of time to all-cause mortality (ACM) and incidence of cardiovascular hospitalizations (CVH).

• In June 2025, Birtamimab is an experimental monoclonal antibody developed to target and remove amyloid deposits that lead to organ damage in patients with AL amyloidosis by binding to a specific epitope on kappa and lambda AL proteins. The AFFIRM-AL study (NCT04973137), a double-blind, placebo-controlled, time-to-event clinical trial, evaluated the safety and effectiveness of birtamimab in 207 newly diagnosed, treatment-naïve individuals with Mayo Stage IV AL amyloidosis. Participants were randomized in a 2:1 ratio to receive either birtamimab or placebo intravenously every 28 days, alongside standard-of-care treatment with a bortezomib-based chemotherapy regimen.

• In May 2025, Prothena Corporation plc (NASDAQ: PRTA) announced that its Phase 3 AFFIRM-AL clinical trial evaluating birtamimab for AL amyloidosis did not meet its primary endpoint (HR=0.915, p=0.7680). Consequently, the company has decided to discontinue the development of birtamimab and will also end the open-label extension phase of the AFFIRM-AL study.

• In February 2025, Immix Biopharma, Inc. (Nasdaq: IMMX), a clinical-stage biopharmaceutical company developing cell therapies for AL amyloidosis and immune-mediated conditions, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its sterically-optimized CAR-T therapy, NXC-201, for the treatment of relapsed/refractory AL amyloidosis. As of June 2024, fewer than half of RMAT requests submitted over the past eight years have received approval. The RMAT designation is reserved for advanced regenerative therapies targeting serious illnesses that show potential—through early clinical data—to treat, modify, reverse, or cure disease and address unmet medical needs.

• In January 2025, Attralus, Inc., a clinical-stage biopharmaceutical company developing novel therapies for systemic amyloidosis, in collaboration with Brigham and Women’s Hospital in Boston, MA, has announced the enrollment of the first patient in the Phase 3 REVEAL study. This clinical trial is evaluating the investigational diagnostic imaging agent 124I-evuzamitide (AT-01) in individuals suspected of having cardiac amyloidosis. The study aims to determine the sensitivity and specificity of 124I-evuzamitide PET/CT imaging for diagnosing the condition. Dr. Sharmila Dorbala, Principal Investigator and Sponsor of the REVEAL study, emphasized the significance of the research, noting that the imaging technique offers a promising noninvasive approach to detecting amyloid deposits in the heart and other organs. Given the serious nature of cardiac amyloidosis, early and accurate diagnosis is critical. With the availability of FDA-approved treatments, a reliable diagnostic scan could play a crucial role in minimizing diagnostic delays and improving patient outcomes.

AL Amyloidosis Overview

AL amyloidosis (also known as light chain amyloidosis) is a rare and serious condition caused by the buildup of abnormal proteins called amyloid light chains in organs and tissues. These proteins are produced by malfunctioning plasma cells in the bone marrow and can accumulate in the heart, kidneys, liver, and nerves, leading to organ damage. Symptoms vary depending on the organs affected and may include fatigue, swelling, shortness of breath, and irregular heartbeat. Early diagnosis and treatment—often involving chemotherapy or stem cell transplant—are essential to prevent irreversible organ damage and improve outcomes.

Get a Free Sample PDF Report to know more about AL Amyloidosis Pipeline Therapeutic Assessment-

https://www.delveinsight.com/report-store/al-amyloidosis-pipeline-insight

Emerging AL Amyloidosis Drugs Under Different Phases of Clinical Development Include:

• LambdaMab: HaemaLogiX

• ZN d5: Zentalis Pharmaceuticals

• STI-6129: Sorrento Therapeutics

• Isatuximab: Sanofi

• Bendamustine: Astellas Pharma GmbH

• Belantamab mafodotin: GlaxoSmithKline

• Ixazomib: Takeda Oncology

• CAEL-101: Caelum Biosciences

AL Amyloidosis Route of Administration

AL Amyloidosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as

• Intra-articular

• Intraocular

• Intrathecal

• Intravenous

• Ophthalmic

• Oral

• Parenteral

• Subcutaneous

• Topical

• Transdermal

AL Amyloidosis Molecule Type

AL Amyloidosis Products have been categorized under various Molecule types, such as

• Oligonucleotide

• Peptide

• Small molecule

AL Amyloidosis Pipeline Therapeutics Assessment

• AL Amyloidosis Assessment by Product Type

• AL Amyloidosis By Stage and Product Type

• AL Amyloidosis Assessment by Route of Administration

• AL Amyloidosis By Stage and Route of Administration

• AL Amyloidosis Assessment by Molecule Type

• AL Amyloidosis by Stage and Molecule Type

DelveInsight’s AL Amyloidosis Report covers around 10+ 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 AL Amyloidosis product details are provided in the report. Download the AL Amyloidosis pipeline report to learn more about the emerging AL Amyloidosis therapies

Some of the key companies in the AL Amyloidosis Therapeutics Market include:

Key companies developing therapies for AL Amyloidosis are – Sorrento Therapeutics, Prothena Therapeutics, Spectrum Pharmaceuticals, Takeda, Millennium Pharmaceuticals, Caelum Biosciences, Astellas Pharma GmbH, Oncopeptides, and others.

AL Amyloidosis Pipeline Analysis:

The AL Amyloidosis pipeline report provides insights into

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

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

• AL Amyloidosis 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 AL Amyloidosis 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 AL Amyloidosis drugs and therapies

AL Amyloidosis Pipeline Market Drivers

• Increase in the number of patients suffering from AL Amyloidosis, increase in awareness about the disease are some of the important factors that are fueling the AL Amyloidosis Market.

AL Amyloidosis Pipeline Market Barriers

• However, high cost of the associated treatment, side effects associated with the treatment and other factors are creating obstacles in the AL Amyloidosis Market growth.

Scope of AL Amyloidosis Pipeline Drug Insight

• Coverage: Global

• Key AL Amyloidosis Companies: HaemaLogiX, Zentalis Pharmaceuticals, Sorrento Therapeutics, Sanofi, Astellas Pharma GmbH, GlaxoSmithKline, Takeda Oncology, Caelum Biosciences, and others

• Key AL Amyloidosis Therapies: LambdaMab, ZN d5, STI-6129, Isatuximab, Bendamustine, Belantamab mafodotin, Ixazomib, CAEL-101, and others

• AL Amyloidosis Therapeutic Assessment: AL Amyloidosis current marketed and AL Amyloidosis emerging therapies

• AL Amyloidosis Market Dynamics: AL Amyloidosis market drivers and AL Amyloidosis market barriers

Request for Sample PDF Report for AL Amyloidosis Pipeline Assessment and clinical trials

Table of Contents

1. AL Amyloidosis Report Introduction

2. AL Amyloidosis Executive Summary

3. AL Amyloidosis Overview

4. AL Amyloidosis- Analytical Perspective In-depth Commercial Assessment

5. AL Amyloidosis Pipeline Therapeutics

6. AL Amyloidosis Late Stage Products (Phase II/III)

7. AL Amyloidosis Mid Stage Products (Phase II)

8. AL Amyloidosis Early Stage Products (Phase I)

9. AL Amyloidosis Preclinical Stage Products

10. AL Amyloidosis Therapeutics Assessment

11. AL Amyloidosis Inactive Products

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

13. AL Amyloidosis Key Companies

14. AL Amyloidosis Key Products

15. AL Amyloidosis Unmet Needs

16 . AL Amyloidosis Market Drivers and Barriers

17. AL Amyloidosis Future Perspectives and Conclusion

18. AL Amyloidosis 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.

Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Gaurav Bora
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: NV
Country: United States
Website: https://www.delveinsight.com/

Press Release Distributed by ABNewswire.com

To view the original version on ABNewswire visit: AL Amyloidosis Pipeline 2025: In-depth Clinical Trials Analysis and Emerging Therapies Report by DelveInsight | Sorrento Therapeutics, Prothena Therapeutics, Spectrum Pharma, Takeda, Millennium Pharma