Anti-CD19 Antibody Pipeline 2025: FDA Approvals and Clinical Trials Landscape with MOA and ROA Highlights by DelveInsight

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Anti-CD19 Antibody pipeline constitutes 12+ key companies continuously working towards developing 12+ Anti-CD19 Antibody treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Anti-CD19 Antibody Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Anti-CD19 Antibody Market.

The Anti-CD19 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-CD19 Antibody Pipeline Report: https://www.delveinsight.com/sample-request/anti-cd19-antibody-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr
• Companies across the globe are diligently working toward developing novel Anti-CD19 Antibody treatment therapies with a considerable amount of success over the years.
• Anti-CD19 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-CD19 Antibody treatment
• Emerging Anti-CD19 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-CD19 Antibody market in the coming years.
• In December 2025, Generalized myasthenia gravis marks Uplizna's second indication expansion this year, following its FDA approval for IgG4-related disease in April. The FDA has now granted approval for a significant label expansion of Amgen's autoimmune therapy Uplizna, permitting its use in adults with specific forms of generalized myasthenia gravis. The therapy is approved for patients who test positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) autoantibodies, making Uplizna the first CD19-targeted B-cell therapy authorized for this indication.
• In April 2025, Amgen's anti-CD19 antibody has secured its second FDA-approved indication, becoming the first therapy authorized to treat IgG4-related disease (IgG4-RD). This approval marks an important milestone as the drug progresses toward potential approval in generalized myasthenia gravis (gMG). Uplizna (inebilizumab-cdon) is now approved for adults with IgG4-RD, a chronic immune-mediated inflammatory disorder that can result in fibrosis and irreversible organ damage. The FDA decision was supported by data from the Phase III MITIGATE trial, which enrolled 135 patients and demonstrated that Uplizna reduced the risk of IgG4-RD flares by 87% compared with placebo over the 52-week controlled treatment period.

Anti-CD19 Antibody Overview
An anti-CD19 antibody refers to a type of monoclonal antibody that specifically targets and binds to CD19, a protein found on the surface of B cells. CD19 is involved in the activation, proliferation, and differentiation of B cells, which play a critical role in the immune response by producing antibodies.

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Emerging Anti-CD19 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-CD19 Antibody Route of Administration
Anti-CD19 Antibody 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
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Anti-CD19 Antibody Molecule Type
Anti-CD19 Antibody Products have been categorized under various Molecule types, such as
• Oligonucleotide
• Peptide
• Small molecule

Anti-CD19 Antibody Pipeline Therapeutics Assessment
• Anti-CD19 Antibody Assessment by Product Type
• Anti-CD19 Antibody By Stage and Product Type
• Anti-CD19 Antibody Assessment by Route of Administration
• Anti-CD19 Antibody By Stage and Route of Administration
• Anti-CD19 Antibody Assessment by Molecule Type
• Anti-CD19 Antibody by Stage and Molecule Type

DelveInsight's Anti-CD19 Antibody Report covers around 12+ 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-CD19 Antibody product details are provided in the report. Download the Anti-CD19 Antibody pipeline report to learn more about the emerging Anti-CD19 Antibody therapies
https://www.delveinsight.com/sample-request/anti-cd19-antibody-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Some of the key companies in the Anti-CD19 Antibody Therapeutics Market include:
Key companies developing therapies for Anti-CD19 Antibody are - TG Therapeutics, Merck kGaA, Generium Pharmaceutical, Sanofi, Incyte Corporation, Amgen, Viela Bio, and others.

Anti-CD19 Antibody Pipeline Analysis:
The Anti-CD19 Antibody pipeline report provides insights into
• The report provides detailed insights about companies that are developing therapies for the treatment of Anti-CD19 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-CD19 Antibody Treatment.
• Anti-CD19 Antibody key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Anti-CD19 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-CD19 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-CD19 Antibody drugs and therapies
https://www.delveinsight.com/sample-request/anti-cd19-antibody-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=gpr

Anti-CD19 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-CD19 Antibody Market.

Anti-CD19 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-CD19 Antibody Market growth.

Scope of Anti-CD19 Antibody Pipeline Drug Insight
• Coverage: Global
• Key Anti-CD19 Antibody Companies: RemeGen, Caribou Biosciences, Precision Biosciences, TG Therapeutics, Xencor, Horizon Therapeutics, Morphosys, and others
• Key Anti-CD19 Antibody Therapies: RC58, CB-010, PBCAR19B, TG-1801, Obexelimab (XmAb5871), Inebilizumab, Tafasitamab, and others
• Anti-CD19 Antibody Therapeutic Assessment: Anti-CD19 Antibody current marketed and Anti-CD19 Antibody emerging therapies
• Anti-CD19 Antibody Market Dynamics: Anti-CD19 Antibody market drivers and Anti-CD19 Antibody market barriers

Contact Us:
Gaurav Bora
gbora@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

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.

This release was published on openPR.