Omeros Corporation

OMER

Held by 2 specialist biotech funds

2 funds opened new positions. Next phase2 readout (Biological: narsoplimab): Dec 2025. Short interest: 16.3% of float.

BiotechnologyCEO: Gregory A. DemopulosIPO: 2009Website ↗

Omeros Corporation is a biopharmaceutical firm with commercialized products, actively engaged in the discovery, development, and market introduction of both small-molecule and protein-based therapies, including treatments for rare diseases. The company's therapeutic endeavors primarily focus on inflammatory conditions, illnesses mediated by the complement system, cancers linked to immune system dysregulation, and disorders characterized by addiction or compulsion. Its robust clinical pipeline features several promising candidates. Narsoplimab (also known as OMS721 or MASP-2), a leading asset, has successfully concluded pivotal trials for hematopoietic stem-cell transplant-associated thrombotic microangiopathy (HSCT-TMA). This drug is also currently undergoing Phase III clinical evaluation for immunoglobulin A nephropathy (IgAN) and atypical hemolytic uremic syndrome (aHUS), in addition to a Phase II trial investigating its potential for treating COVID-19. Further expanding its clinical portfolio, Omeros is developing PPAR? (OMS405) in Phase II for opioid and nicotine dependence. PDE7 (OMS527) is progressing through Phase I studies for addiction, compulsive disorders, and movement disorders. Additionally, MASP-3 (OMS906) is currently in Phase I trials for paroxysmal nocturnal hemoglobinuria (PNH) and other conditions involving the alternative complement pathway. Beyond its clinical efforts, the company maintains a dynamic preclinical program. This includes small-molecule inhibitors targeting MASP-2, which are being explored for applications in aHUS, IgAN, HSCT-TMA, and age-related macular degeneration. Also in development is a next-generation, longer-acting antibody that targets MASP-2, alongside MASP-3 small-molecule inhibitors designed to address PNH and other alternative pathway disorders. Omeros's preclinical research further encompasses GPR174 inhibitors, as well as Chimeric Antigen Receptor (CAR) T-Cell and Adoptive T-Cell Therapies for various oncological indications. The company is also investigating G protein-coupled receptor targets for a broad spectrum of diseases, including immunological, immuno-oncological, metabolic, central nervous system (CNS), cardiovascular, musculoskeletal, and other conditions. Established in 1994, Omeros Corporation is headquartered in Seattle, Washington.

Catalysts

Phase 2PositiveQ1 2009OMS302Cataract ExtractionNCT00721695

Primary: Pupil diameter (Day of Surgery)Enrollment:60/60Sites: 4RANDOMIZED, TRIPLE, TREATMENT

Phase 3PositiveQ2 2009OMS103HPPostoperative PainNCT00624845

Primary: The primary efficacy endpoint is the mean VAS at 24 hours postoperatively. (24 hours)Enrollment:Target 200Sites: 8RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ1 2010OMS103HPAnterior Cruciate Ligament ReconstructionNCT00245271

Primary: The overall incidence of adverse events regardless of relationship to study drug. (90 days)Enrollment:Target 480Sites: 10RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ3 2010OMS103HPKnee InjuriesNCT00226772

Primary: Improvement in knee function (30 days)Enrollment:326/326Sites: 18RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ3 2010OMS103HPKnee InjuriesNCT00226759

Primary: Improvement in knee function (30 days)Enrollment:321/321Sites: 20RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q4 2010OMS201Urinary Calculi, Urinary Stones, Urinary Tract StonesNCT00857090

Primary: Peak systemic exposure. (Day of surgery)Enrollment:18/18Sites: 4RANDOMIZED, TRIPLE, TREATMENT

Phase 2Q1 2011OMS302 SolutionCataractNCT01193127

Primary: Pupil Diameter (mm) During Surgery (During surgery (immediately prior to surgical incision to wound closure))Enrollment:223/223Sites: 24RANDOMIZED, DOUBLE, TREATMENT

Phase 3PositiveQ1 2012OMS302Intraocular Lens ReplacementNCT01454063

Primary: Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm) During Surgery (from surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure))Enrollment:405/405Sites: 16RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q4 2012OMS103HP-SMeniscal TearNCT01406561

Primary: KOOS Symptoms Subscale (30 days)Enrollment:344/344Sites: 18RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ4 2012OMS302Intraocular Lens ReplacementNCT01579565

Primary: Mean Area Under the Curve Analysis of Change-from-Baseline in Pupil Diameter (mm) During Surgery (From surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure))Enrollment:416/416Sites: 14RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q2 2014OMS643762SchizophreniaNCT01952132

Primary: Safety (14 days)Enrollment:40/40Sites: 1RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3NegativeQ3 2014Part 1 OMS302Intraocular Lens Replacement, Intraoperative Floppy Iris SyndromeNCT02093689

Primary: Change in Pupil Diameter (Intraoperative)Enrollment:18/18Sites: 2NON_RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2NegativeQ4 2014OMS643762Huntington's DiseaseNCT02074410

Primary: Assess the Safety of OMS643762 (28 days)Enrollment:22/22Sites: 9RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ3 2016OMS302Unilateral Cataract Extraction, Congenital CataractNCT02132312

Primary: Intraoperative Pupil Diameter (From surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure), the mean time of surgery duration is 35.46 minutes with a standard deviation of 19.98.)Enrollment:78/78Sites: 11RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2PositiveQ1 2020OMS721Thrombotic MicroangiopathiesNCT02222545

Primary: Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA (Day 1 to 37 days after end of treatment, approximately up to 31 weeks.)Enrollment:58/58Sites: 24NON_RANDOMIZED, TREATMENT

Phase 2NegativeQ3 2020OMS721 (narsoplimab)Ig AN, LN, MNNCT02682407

Primary: Cohort 1-3: Proportion of IgAN, LN, MN, C3 Glomerulopathy Participants With Treatment Related Adverse Events (AE). (up to 104 weeks)Enrollment:31/31Sites: 12RANDOMIZED, TRIPLE, TREATMENT

Phase 3NegativeQ1 2021OMS721 (narsoplimab)Thrombotic Microangiopathies, Atypical Hemolytic Uremic SyndromeNCT03205995

Primary: Platelet Count (10^9 Platelets/L) Change From Baseline at Week 26 (Week 26)Enrollment:6/6Sites: 4NA, TREATMENT

Phase 3NegativeQ1 2024OMS721Ig A NephropathyNCT03608033

Phase 2Q4 2024OMS906Paroxysmal Nocturnal HemoglobinuriaNCT05972967

Phase 2Q4 2025Biological: narsoplimabThrombotic Microangiopathies, Hematopoietic Stem Cell TransplantationNCT05855083

Primary: 100-day survival rate following high-risk HSCT-TMA diagnosis. (100 days)Enrollment:Target 18Sites: 16NA, TREATMENT

Phase 2Q1 2026OMS906 study drugC3 Glomerulopathy, Idiopathic Immune Complex-Mediated GlomerulonephritisNCT06209736

Primary: To assess OMS906 5mg/kg IV administration at 4-week intervals in patients with C3G and ICGN. (48 weeks)Enrollment:Target 20Sites: 6NA, TREATMENT

Phase 2Q4 2026OMS906 study drugParoxysmal Nocturnal HemoglobinuriaNCT06298955

Primary: To assess overall safety and tolerability of OMS906 administration at 8-week intervals in PNH patients. (104 weeks)Enrollment:Target 25Sites: 5NA, TREATMENT

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