Narsoplimab Drug Asset Due Diligence Report 2026

This Narsoplimab Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.

Decision date: 15 July 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.

Approved

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: GO

Decision memo

Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.

The central underwriting question is whether Narsoplimab can convert its Monoclonal antibody profile and MASP2 biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Narsoplimab (query alias: narsoplimab)
Modality / target	Monoclonal antibody; MASP2; MASP2 inhibitors
Highest global status	Approved
Originator	Omeros Corp.
Active developers	Omeros Corp.

The MCP disease footprint includes Thrombotic Microangiopathies, Hematopoietic stem cell transplantation, COVID-19. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.

2. Clinical program: design and endpoint audit

Registry	Phase	Status	Enrollment	Lead primary endpoint
NCT03608033	Phase 3	Terminated	360	Percent Change in 24-hour UPE in g/Day Compared to Baseline
NCT04488081	Phase 2	Active, not recruiting	1500	Identify agents that will result in substantial improvements to the clinical condition of participants with COVID-19.
NCT05855083	Phase 2	Recruiting	18	100-day survival rate following high-risk HSCT-TMA diagnosis.

The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.

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3. Clinical readouts: what is known

FDA-Approved Drugs-YARTEMLEA-CLINICAL STUDIES

Not Applicable; n=73; evaluation: Positive. Reported fields: -; complete TMA response = 67.0 % (95%CI, 22.3 - 95.7); complete TMA response = 61.0 % (95%CI, 40.6 - 78.5)

A Phase 3 Study to Evaluate the Safety and Efficacy of OMS721 for the Treatment of Atypical Hemolytic Uremic Syndrome (aHUS) in Adults and Adolescents

Phase 3; n=6; evaluation: not stated. Reported fields: Platelet Count (10^9 Platelets/L) Change From Baseline at Week 26(Median) = 42 10^9 platelets/L (Full Range, -21 to 115.5); -; -

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN)

Phase 3; n=360; evaluation: not stated. Reported fields: Percent Change in 24-hour UPE in g/Day Compared to Baseline(Least Squares Mean) = -16.6 Percent Change (Standard Error, 0.0680); Percent Change in 24-hour UPE in g/Day Compared to Baseline(Least Squares Mean) = -21.3 Percent Change (Standard Error, 0.0672); -

These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.

4. Market and competitive position

Narsoplimab addresses Thrombotic Microangiopathies, Hematopoietic stem cell transplantation, COVID-19. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Monoclonal antibody—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The strongest market-validation signal in this screen is partner behavior: 2 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2018-12-11	Omeros Announces Research Collaboration With University Of Cambridge	Phase 3	Financial terms not disclosed
2008-08-19	AFFITECH AND OMEROS ENTER INTO ANTIBODY DISCOVERY AND DEVELOPMENT AGREEMENT	Not disclosed	Financial terms not disclosed

Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.

6. IP and freedom-to-operate screen

The milestone feed surfaced a patent-application signal described as “MASP-2 and MASP-3 inhibitors, and related compositions and methods, for treatment of sickle cell disease”. The milestone feed surfaced a patent-application signal described as “Methods of inhibiting MASP-2 for the treatment and/or prevention of coronavirus-induced acute respiratory distress syndrome”. The milestone feed surfaced a patent-application signal described as “Compositions and methods of inhibiting MASP-2 for the treatment of various thrombotic diseases and disorders”.

The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights. Confirm that licensed patents, data and know-how track every granted territory and field.

7. Principal risks and diligence gates

Class crowding and differentiation versus other PD-(L)1/VEGF agents
Immune and anti-angiogenic safety, including bleeding and cardiovascular risk
Biomarker strategy, indication selection, and head-to-head endpoint execution

Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.

8. Final go/no-go memorandum

GO